Opiate and prescription medication abuse constitutes a continuing public health crisis in the United States. According to recent estimates by the CDC, more than 90 Americans die each day from opiate overdose,1 and current estimates place the total economic burden of prescription opiate medication misuse alone at $78.5 billion a year.2 To monitor patient compliance with prescribed medications and to identify recent use of non-prescribed medications or illicit substances, Clinical Pathology Laboratories (CPL) in partnership with Sonic Reference Laboratory (SRL), A Sonic Healthcare Company, will begin to offer in-house Drug Monitoring Profiles designed for patients who have been prescribed pain management or other controlled substance prescription medications starting on July, 15 2019. 

CPL and SRL’s Drug Monitoring program includes testing for 30 different classes of drugs with screening performed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) or immunometric techniques and with reflex or directly ordered confirmation performed by high-resolution LC-MS/MS. Individual classes range from one to many individual tests (see attached Drug Monitoring Attachment). In addition to individual classes, providers may choose profiles as appropriate to meet the needs of their patient compliance monitoring: 

Profile NameScreen CodeScreen/Reflex CodeClassesComponents
Drug Monitoring Profile 1246524669Classic opiates, oxycodone, fentanyl, benzodiazepines, amphetamines, designer amphetamines, gabapentin/pregabalin, ethanol and typical illicits
Drug Monitoring Profile 22467246815Profile 1 + meperidine, methadone, tapentadol, tramadol, naloxone/naltrexone/butorphanol, buprenorphine.
Drug Monitoring Profile 32469247116Profile 2 + skeletal muscle relaxants.
Drug Monitoring Profile 42472247323Profile 3 + barbiturates, cathinones (bath salts), dextromethorphan, D-type illicits (DMT, MEO- DMT), K-type illicits (Kava, Kratom), ketamine and synthetic cannabinoids.
Comprehensive Drug Monitoring Profile2451245226Profile 4 + anticonvulsants, antidepressants, antipsychotics.

Further notes about this service:

  1. Natural cannabinoids, nicotine, and non-opioid analgesics (e.g. acetaminophen) can be ordered separately with any one of the panels above. These medications may be outside of the specifications of many monitoring programs. 

  2. Short acting sedatives (Zolpidem, Zaleplon, Zopiclone) can be ordered separately with any one of the panels above. These are best assessed with use of a frozen specimen as they have decreased refrigerated stability. 

  3. For medication review in context of test results, please submit a list of prescribed medications. The Drug Monitoring Attachment can be used to document medications in addition to requesting specific Drug Monitoring Profiles or classes to be tested. 

  4. All specimens are also subjected to validity testing to assess for adulteration. Please review report notes carefully. 

  5. An enhanced report is available summarizing the medication list, all positive results and salient negative results (inconsistent negative – if a medication list is provided) at the top of the report with the results a complete analysis in the body of the report. Where possible, the enhanced report will include historical results. This report can be provided under separate cover. Please review this with your CPL Account Representative. 

 REFERENCES 

  1. Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal WklyRep. 2016;65. doi:10.15585/mmwr.mm655051e1. 
  2. Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. MedCare. 2016;54(10):901-906. doi:10.1097/MLR.0000000000000625. 

Printable Version

Printable Drug Monitoring Attachement

Effective July 1, 2019, Clinical Pathology Laboratories will change the current reagents and instrumentation for lymphocyte subset analysis and enumeration to the Beckman Coulter AQUIOS CL Flow Cytometry System using AQUIOS Tetra-1 and Tetra-2+ Panels.
NOTE: Adult reference ranges and specimen stability will be updated concurrent with this change.

Fluorochrome

 FITCRD1ECDPC5
AQUIOS Tetra-1CD45CD4CD8CD3
AQUIOS Tetra-2+CD45CD16+56CD19CD3

 

The AQUIOS CL is a fully automated flow cytometry system based on precise volumetric sampling to produce efficient, high-throughput lymphocyte subset analysis. In the clinical diagnosis and management of immune deficiency diseases, accuracy and precision in the enumeration of relative (percent) and absolute lymphocyte subsets is critical. The volumetric AQUIOS CL method eliminates the need for and variability produced by the introduction of fluorescent beads to the specimen. The platform is validated for identification and enumeration of T, B, and NK lymphocytes in whole blood.

Order Codes:4870, 5664, 4875, 4873, 4865, 4813, 4594, 3735*
Test Method:AQUIOS Tetra-1 and Tetra-2+ Lymphocyte Subset Analysis
Specimen Requirements:4 mL EDTA Whole Blood*
Specimen Rejection Criteria:Hemolysis, Refrigerated Samples, Frozen Samples, and Heparin Samples*
Transport Temperature/StabilityCritical Room Temperature* up to 2 days
Performed:Monday - Sunday*
Analytic Time:1 day*
Reference Ranges (18YRS):

CD3% 58.0-84.0%

CD3 ABS 850-2240 cells/μL

CD4% 34.0-65.0%

CD4 ABS 520-1470 cells/μL

CD8% 13.0-38.0%

CD8 ABS 205-920 cells/μL

CD19% 6.0-25.0%

CD19 ABS 87-507 cells/μL

CD16+56% 4.0-27.0%

CD16+56 ABS 74-562 cells/μL

CPT Codes:86360, 86359, 86357, 86355*

 

*Unchanged from previous version

Printable Version

Effective March 4, 2019

Clinical Pathology Laboratories (CPL) will change current immunochemistry instrumentation and reagents to Roche COBAS® Electrochemiluminescent (eCLIA) methodology for the following assays:

  • Adrenocorticotropic hormone (ACTH)
  • C-peptide
  • Dehydroepiandrosterone sulfate (DHEA-S)
  • Human growth hormone (HGH)
  • Insulin-like growth factor 1 (IGF-1)
  • Insulin-like growth factor binding protein 3 (IGF-BP3)
  • Intact parathyroid hormone (iPTH)

The Roche assays provide improved precision and sensitivity, partially due to high-specificity biotin-streptavidin interactions in the immunoassay.1 As a result of this change all related reference ranges, specimen requirements, analytic measuring ranges and interferences were reviewed. The reference ranges for all analytes are modified in the validation process, with gender and age-stratification applied as appropriate. For certain assays, previously supplied Tanner charts are not currently available; instead, providers may reference granular gender- and age-stratified normal ranges. The Tanner charts may be reestablished for specific analytes with literature review and after accumulation of population data and analysis.

The reference interval changes have been distributed to the interfaced laboratory users group in a separate communication. If you or your practice requires a chart of the reference intervals across gender or age, please contact your CPL Account Representative.

Laboratory reports will be appended with a notice of the change in reference range and method as a part of this transition. As always, please review your laboratory results in the context of the provided reference interval and flagging.

Please contact your CPL Account Representative should you have any questions regarding this change.

1 Assays may be susceptible to interference by high doses (e.g. >5 mg/day) of biotin. Patients should avoid high dose biotin supplements for at least 8 hours prior to phlebotomy.

Printable Version

Dear CPL Client,

We have just received a notice from Beckman-Coulter, the manufacturer of our Thyroglobulin Antibody assay reagent, that a possibility exists for decreased sensitivity for Thyroglobulin Antibody detection in a subset of patient samples tested with specific lot numbers of reagent. CPL was provided with the impacted lot numbers to test patients during the time period of 11/4/2018 to 2/19/2019. CPL immediately replaced this reagent lot with a new formulation not affected by this issue.

With potentially decreased sensitivity for TG Antibody, the impacted results may be inconsistent with clinical presentation, other laboratory tests, or imaging results. If you suspect that this issue impacted your patients’ results, please contact your CPL Account Representative to review and arrange for reassessment. For clinical questions regarding this testing, please contact customer service at 800.633.4757.

We regret the inconvenience that this may cause you and your patients.

Printable Version

UnitedHealthcare® Community Plan Detail

Effective December 10, 2018,

Clinical Pathology Laboratories (CPL) will no longer offer Helicobacter pylori (H. pylori) serology testing in support of the current diagnostic guidelines for H. pylori. The Effective December 10, 2018, Clinical Pathology Laboratories (CPL) will no longer offer Helicobacter pylori (H. pylori) serology testing in support of the current diagnostic guidelines for H. pylori.

The discontinued tests are as follow:
Order CodeTest Name
4565H. pylori IgG, Qualitative 
4496H. pylori Antibody Reflex Quantitative
4611H. pylori IgA Antibody
4672H. pylori IgG Antibody
4607H. pylori IgM Antibody
4449H. pylori IgG/IgA Antibodies
4609H. pylori IgG, IgM, IgA Quantitative
CPL recommends the following alternative assays:
Order CodeTest Name
4499H. pylori Antigen, Stool
5591H. pylori (Breath)
5653H. pylori (Breath), Pediatric 

 

To better support high quality patient care, CPL will inactivate the serology test codes for H. pylori listed above and recommend active infection assays. These changes are consistent with the current diagnostic guidelines of the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA) that recommend either the urea breath test or the stool antigen test as preferred testing modalities for active H. pylori infection. These alternative noninvasive testing methods demonstrate higher clinical utility, sensitivity and specificity.

Serologic evaluation of patients to determine the presence or absence of H. pylori infection is no longer considered clinically useful. As a result, many insurance providers are no longer providing coverage to patients for serologic testing. Antibody tests cannot distinguish between active and past infection with adequate sensitivity and specificity. Despite older literature suggesting that IgG serology can be used as a test of cure after 18 months, this has shown to be inaccurate. Both the urea breath test and stool antigen test are FDA cleared for use as a test of eradication.

Please contact your CPL Account Representative should you have any questions regarding this change.

Choosing Wisely: Fifteen Things Physicians and Patients Should Question, 2016; American Society for Clinical Pathology (ASCP)

Printable Version

Effective September 10, 2018

Clinical Pathology Laboratories (CPL) will no longer offer BNP (order code 5585). Consider NT-proBNP (order code 5722) as replacement. NT-proBNP offers better stability and reduced interference to common Neprilysin inhibitors.

Atrial- and brain-type natriuretic peptides (ANPs and BNPs) are produced in cardiac tissues in response to ventricular dysfunction and atrial distension.

NT-proBNP aids in the:

  • Diagnosis and prognosis of individuals suspected of having congestive heart failure
  • Risk stratification of patients with acute coronary syndrome and congestive heart failure
  • Assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease

NT-proBNP, in contrast to Brain Natriuretic Peptide (BNP), is:

  • Unaffected by the new class of Neprilysin Inhibitors (e.g. Entresto)
  • Suitable as a biomarker for congestive heart failure
  • Stable when collected, stored and transported at ambient, refrigerated and frozen temperatures

The table below demonstrates NT-proBNP performance characteristics by age range.

 MaleFemale
Age in Years45-5455-6465-74> 7545-5455-6465-74> 75
% Sensitivity88.269.691.786.590.589.394.381.8
% Specificity93.387.886.788.985.579.957.887.9
% Prevalence1.86.26.89.81.33.46.69.7
% NPV99.899.299.398.899.999.599.397.8
Order Code/ Test Name:5722  NT- proBNP
Test Method:Electrochemiluminesence Immunoassay (ECLIA)
Specimen Requirements:2 mL serum. Allow Serum Separator Tube (SST) to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate (2-8 °C) Note: Samples should not be collected from patients receiving therapy with high Biotin doses (> 5 mg/day) until at least 8 hours following the last Biotin administration.
Specimen Rejection Criteria:Grossly hemolyzed specimens will be rejected
Transport Temperature:Refrigerated (2 - 8 °C)
Stability (collection to initiation of testing):

Ambient: (15 - 25 °C) 3 days

Refrigerated: (2 - 8 °C) 6 days

Frozen: (≤ -20 °C) 1 month

Performed:Monday through Friday
Analytic Time:1 day
Reference Range:

< 50 years: 450 pg/mL or less

50-75 years: 900 pg/mL or less

> 75 years: 1800 pg/mL or less

CPT Code:83880

If you have concerns about patients with known BNP baselining, please contact your CPL Account Representative.

Printable Version

Date: June 4, 2018

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements.

Medicare Medical Necessity Policy

Medicare will only pay for the tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, but which does not meet the Medicare definition of medical necessity. 

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define the medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD code(s) to be present on each claim filed. These codes must also be documented in the patient’s medical records.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, covered diagnosis codes(s), coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPSQuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels The (AMA) panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate or required by state, regulatory or accreditation standards. 
Advance Beneficiary Notice of Non-Coverage (ABN)

  • Limited Coverage – An ABN is required if the diagnosis is not covered
  • Frequency Limit - An ABN is required at each encounter for frequency limited tests
  • Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare an non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN) 2018 Medicare Clinical Laboratory Fee Schedule Effective January 1, 2018, CLFS rates are based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-LaboratoryFee-Schedule-Files.html Additional details can be found at PAMA regulations. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMARegulations.html Medicare Part B National Correct Coding Initiative (NCCI) Edits The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment. https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html
Contact Information The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call 512.339.1275 or 800.595.1275 for assistance. You may also contact our Compliance Department at compliancedept@cpllabs.com. Please review this notice with all appropriate staff. 

Printable Version

Effective June 18, 2018, Clinical Pathology Laboratories (CPL) will no longer offer in-house testing for Cancer Antigen 27.29 (CA 27.29) due to manufacturer reagent unavailability. Cancer Antigen (CA 15-3), order code 4827, testing is routinely performed in-house and may be considered an appropriate alternative.

Both CA 27.29 and CA 15-3 are mucin antibodies which detect soluble forms of MUC-1, a transmembrane mucin which can become overexpressed in epithelial cancer cells. Analytic antibodies for CA 27.29 partially overlap the binding sites used for CA 15-3 testing, yielding clinically similar results. According to Centers for Medicare and Medicaid Services (CMS) policy, CA 27.29 is equivalent to CA 15-3 in its usage in management of patients with breast cancer. Serial tumor marker testing must be used in conjunction with other clinical methods for monitoring breast cancer. If medically necessary for monitoring, clinicians should consistently use either CA 15-3 or CA 27.29, not both. CPL will offer rebaselining for initial transition from CA 27.29 to CA 15-3 from June 18, 2018 to August 31, 2018.

Please contact your Account Executive should you have any questions regarding rebaselining and testing details.

Order Code/Test Name:4827 Cancer Antigen 15-3
Test Method:Electrochemiluminesence Immunoassay (ECLIA)
Specimen Requirements:2 mL serum. Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate. Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration.
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient: (15 - 25 °C) 2 days

Refrigerated: (2 - 8 °C) 5 days

Frozen: (≤ -20 °C) 3 months

Performed:Monday through Friday PM Shift
Analytic Time:1 day
Reference Range:≤25 U/mL
CPT Code:

86300  (LOINC code:  6875-9)

Limited Coverage Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) required if diagnosis not covered

Printable Version

Effective 06/18/2018, Clinical Pathology Laboratories (CPL) will replace current drug of abuse (DAU) screening and screening with reflex confirmation profiles.

The new profiles provide:

  • Reformulation and recombination of classes for profile testing, more relevant to current societal trends
  • Standardization of drug thresholds to high sensitivity cutoff values
  • Addition of the following analytes in specific profiles for testing:
    • Fentanyl  
    • Buprenorphine
    • 6-Acetylmorphine
    • MDMA (Ecstasy)
  • Expansion of testing for adulterants with disqualifying comments added to specimens determined to be altered
  • Expansion of interpretive notes on reports regarding the method, cutoff values, and specific drugs that may or may not be detected by the screening method
Test NameOrder CodeTests Detected
Drug of Abuse, 8 Analytes No Confirmation3305Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine
Drug of Abuse, 8 Analytes w/ Confirmation3306Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine
Drug of Abuse, 9 Analytes No Confirmation3316Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, EtOH
Drug of Abuse, 9 Analytes w/ Confirmation3315Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, EtOH
Drug of Abuse, 10 Analytes No Confirmation3307Amphetamines, Barbituates, Benzodiazepines, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 10 Analytes w/ Confirmation3308Amphetamines, Barbituates, Benzodiazepines, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 11 Analytes No Confirmation3317Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 11 Analytes w/ Confirmation3254Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 12 Analytes No Confirmation3310Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, EtOH
Drug of Abuse, 12 Analytes w/ Confirmation3311Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, EtOH
Drug of Abuse,  13Analytes No Confirmation3312Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy
Drug of Abuse, 13 Analytes w/ Confirmation3309Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy
Drug of Abuse, 14 Analytes No Confirmation3313Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy. EtOH
Drug of Abuse, 14 Analytes w/ Confirmation3314Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy. EtOH

Additional information for the newly added analytes:

  • Fentanyl: a potent synthetic opioid usually not detectable by standard opiate testing
  • Buprenorphine: a semisynthetic opioid receptor partial agonist, used in place of or with methadone for detoxification or opioid replacement therapy
  • 6-Acetylmorphine: a heroin metabolite, produced very quickly from the short-lived parent and detectable in the urine for approximately 8 hours after use
  • MDMA (Ecstasy): a sympathomimetic stimulant related to amphetamine with significantly fewer CNS stimulant properties than methamphetamine 

 Testing to be eliminated from the screening and screen/reflex profiles:

  • Methaqualone (Quaaludes): this drug was discontinued in the US in 1985; screening programs very rarely produce positive results, most of which are determined to be false positives
  • Propoxyphene (Darvon): this drug was discontinued in the US in 2010 due to cardiac arrhythmias

The following order codes will be discontinued:

3202, 3203, 3204, 3205, 3206, 3210, 3211, 3212, 3220, 3225, 3250, 3251, 3255, 3258, 3270, 3272, 3285, 3290, 3295, 3296, 5813, 5867, 5869, and 5910.

Order code 3254, formerly known as DRUG ABUSE PANEL 10 WITH OXYCODONE will be modified as represented in the chart on reverse side.

The testing represents conventional drug of abuse screening using immunoassay (IA) methods and, where requested, reflex confirmation by chromatography with mass spectrometry. This IA technology is designed to react at a certain threshold to particular members of a drug class. For some classes certain compounds will not measure above the screen threshold. Additionally, chemically related compounds may trigger a "false positive" screen.

Confirmatory testing is performed for positive screens at an additional charge for those profiles designated “W/CONFIRM” on reverse side. Positive screens are reflexed and performed by a different technology, either gas chromatography with mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS or LC-MS/MS if tandem). The confirmatory testing provides higher sensitivity testing with lower thresholds, definitive analyte identification and quantitation without analytic false positives. 

Additional test information:

Order Unit Code/Test Name:See table 
Test Method:Immunoassay Screen 
Specimen Requirements:50 mL Random Urine. No Preservative. Refrigerate.
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient, 15-25°C: 1 week

Refrigerated, 2-8°C: 1 week

Performed:Monday through Friday / PM Shift
Analytic Time:1 day
Reference Range:Negative 
CPT Code:80307

Limited Coverage Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) required if diagnosis not covered. Frequency Limit Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) is always required. There must be documentation, by the clinician, in the patient’s medical record, to support the medical necessity and frequency of drug testing on an individual basis.

Please contact your CPL Account Representative should you have any questions regarding this change. Printable Version

 

Effective March 26, 2018, Clinical Pathology Laboratories will change the current instrumentation for Insulin testing from Siemens Immulite to Roche Cobas e602 using Electrochemiluminescence Immunoassay (ECLIA) technology. As a result of this change, all related reference ranges were reviewed and modified as listed below.

Order CodeInsulin ValueSiemens Reference Range µIU/mLRoche Reference Range µIU/mL
2760Random4-132-21
2749Fasting4-132-21
27561/2 hour12-5822-133
27571 hour17-4633-104
27641 1/2 hour15-4429-99
27582 hour13-4225-93
27593 hourNot establishedNot established
27614 hourNot establishedNot established
27625 hourNot establishedNot established
27636 hourNot establishedNot established

Note: Reference ranges for timed specimens are given presuming a 75 gm oral glucose. The Random reference range presumes standard overnight fast as well.

Additional Test Information:

Specimen Requirements:2 mL serum from SST
Specimen Rejection Criteria:Hemolysis, Allow only 1 Freeze/Thaw Cycle
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):24 Hours Room Temperature; 4 Days Refrigerated; 1 Month Frozen
Performed:Monday through Friday
Analytic Time:1 Day
Specimen Retention:1 Week 
CPT Code:83525

Please contact your Account Executive should you have any questions regarding this change. 

Printable Version

Effective April 2, 2018, Clinical Pathology Laboratories is pleased to announce a change in methodology and reference range for Thyroxine Binding Capacity (TBC) and a change in reference range for total thyroxine (T4) with transition to the Roche Cobas electrochemiluminescence immunoassay (ECLIA) method. Traditionally, the excess TBC of serum was indirectly assayed with a T3-resin uptake (T3RU). The Roche ECLIA method is a direct measure of TBC which will also allow a calculated T-Uptake in percentage. Free thyroxine index (FTI), an estimate of the free fraction of T4, is calculated using the TBC and Total T4.

T-Uptake:

  • Increased in hyperthyroidism or with decreased unsaturated Thyroid Binding Globulin (TBG)
  • Decreased in hypothyroidism or with increased unsaturated TBG

TBC:

  • Decreased in hyperthyroidism or with decreased unsaturated TBG
  • Increased in hypothyroidism or with increased unsaturated TBG

FTI:

  • Historically, FTI was the product of total T4 and T3RU divided by 100
  • Using Roche, FTI is the ratio: T4/TBC

Changes in Reporting:

AssayTest CodePrior Reference RangeNew Reference RangeNotes
ThyroxineT428194.5-12.0 ug/dL4.5-10.5 ug/dL 
T-Uptake%281724.3-39.0 %24.3-39.0%Mathematically derived from TBC
Thyroxine Binding CapacityTBC28171New0.8-1.3 (no units)Directly proportional to unsaturated thyroxine binding capacity.
Corrected T4FTI28201.5-3.80 (no units)4.2-11.6 ug/dLRatio of T4/TBC. Thyroid I and II Profiles (profile codes 117 and 119) contain Thyroxine (T4), T-Uptake, Corrected T4 (FTI) 
Order Unit Codes and Test Names:2817 T-Uptake / 2819 Thyroxine (T4)
Specimen Requirements:2 mL serum. Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate. Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration. 
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient, 15-25°C: 1 day

Refrigerated, 2-8°C: 7 days

Frozen, (-15)- (-25)°C: 1 month

Performed:Monday through Friday / PM Shift
Analytic Time:1 day
CPT Code:T-Uptake: 84479 / Thyroxine (T4): 84436

Printable Version

Laboratory tests such as immunoassays use antibodies to detect and quantitate analytical compounds and often use a biotin linker to enhance sensitivity and accuracy. High dose biotin taken within 1 or 2 days or lower dose biotin taken within a few hours prior to sampling may affect the accuracy of laboratory testing for those assays that include a biotin component. 

As a consequence, the US Food and Drug Administration (FDA) has issued a Safety Communication: The FDA Warns that Biotin May Interfere with Lab Tests (https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm586505.htm)

What does this mean for patients and providers?

  • Patients on high dose supplements of biotin, such as hair/nail/skin supplements, should refrain from taking them in the 24 hours prior to laboratory testing.
  • These supplements may or may not indicate they contain biotin prominently.
  • Patients taking prescribed megadose regiments (>150 mg biotin) should refrain from taking the supplement for 24-48 hours prior to laboratory testing, upon the advice of their physician.
  • Patients and physicians should review any lab test result that does not match the clinical presentation and consider if biotin interference is present. 

 Background information:

  • Biotin, or vitamin B7, is often found in multi-vitamins, prenatal vitamins, and dietary supplements, which may not be clear from the name of the supplement.
  • Patients and clinicians should be aware that a number of immunoassay lab tests, including but not limited to cardiovascular diagnostic tests, thyroid tests, and certain other hormone tests, may be affected by biotin interference.
  • The US recommended daily allowance (US RDA) for biotin is 0.03 mg.
  1. The amount of biotin often found in multivitamins does not typically cause significant interference.
  2. Supplements containing high biotin levels including those marketed for hair, skin, and nail benefits may contain 5-20 mg of biotin (200-600 times US RDA).
  3. Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests. 

 References:

Printable Version

Effective December 18th, 2017, Clinical Pathology Laboratories will change the current instrumentation and reagents for CMV testing in EDTA plasma from the Roche AmpliPrep/TaqMan 2.0 to the new Roche cobas® CMV quantitative nucleic acid test on the cobas 8800.

The intended use of both assays is as an aid in the management of CMV in solid organ transplant (SOT) patients and in hematopoietic stem cell transplant (HSCT) patients, specifically including serial DNA measurements to assess viral response to treatment.

Both assays are traceable to WHO International Standards and demonstrate strong quantitative correlation to one another.  

Due to assay design changes there could be differences in quantitation for individual patients.

  • The lower limit of quantitation has decreased from 137 IU/mL to 35 IU/mL. With higher sensitivity, this assay will result in more samples with low quantifiable results.
  • More samples will show a “detected” result below the limit of quantitation when previously a result of “not detected” may have been reported.
  • In clinical specimens for both SOT and HSCT, Roche found a slight positive bias in new CMV assay relative to the TaqMan CMV (approximately 0.2 log IU/mL).
  • Rare samples showed discrepant viral loads between the two assays due to polymorphisms within CMV target sequences. 

Retesting and verification of CMV results may be necessary if a result with the new assay is clinically unexpected. Please contact a CPL Pathologist if there are any questions regarding this testing.

Order Unit Code/Test Name: 4019, 4187 CMV BY PCR QUAL/QUANT and QUANT  
Test Method: Polymerase chain reaction (PCR) by Roche Cobas 8800
Specimen Requirements: 3 mL EDTA plasma
Specimen Rejection Criteria: Samples received in frozen BD PPT tube, serum, heparin plasma 
Transport Temperature: Frozen or Refrigerated*  
Stability (collection to initiation of testing): 6 Days Refrigerated; 12 Weeks Frozen  
Performed: Monday, Wednesday, Friday  
Specimen Retention:2 Weeks  
Range of quantitation: 35 – 1.0E+07 IU/mL (1.54 – 7.00 log IU/mL)**  
CPT Code:87497  

* Previous transport temperature was frozen only

**Previous range of quantitation: 137 – 9.1E+06 IU/mL (2.14 – 6.96 log IU/mL)

Order Unit Code 4045 CMV by PCR, Qual/Quant, Whole Blood is unaffected by this change. 

Printable Version

Effective September 18, 2017, Clinical Pathology Laboratories will offer in-house testing for Anti-Mullerian Hormone using the Roche COBAS Elecsys Electrochemiluminescence Immunoassay.

Anti-Mullerian Hormone (AMH) is: 

  • a glycoprotein belonging to the transforming growth factor β (TGF-β) family that controls ovarian folliculogenesis.
  • expressed in primary follicles and is maximal in granulosa cells of preantral and small antral follicles.
  • relatively stable during the menstrual cycle with more fluctuation observed in younger women.
  • decreased significantly under influence of certain oral contraceptives.

 The Roche COBAS AMH assay is FDA approved for assessment of ovarian reserve in the management of fertility patients, correlating with ovarian antral follicle counts (AFC). An interpretive chart for the new method provides age-stratified reference ranges as follows:

Female Age Bracket (years)AMH Reference Range (ng/mL)
20-241.22-11.7
25-290.890-9.85
30-340.576-8.13
35-390.147-7.49
40-440.030-5.47

 In validation of the Roche Elecsys AMH assay, CPL confirmed a 40% negative bias relative to the prior method, Ansh picoAMH ELISA assay.

AMH values were correlated to the antral follicle count (AFC) in a study of 856 women presenting to fertility clinics. Patients excluded from the study included those with polycystic ovarian syndrome (PCOS), extremes of body mass, ovarian masses, ovarian surgery, endocrine disease, and oral contraceptive use. AFC was determined by transvaginal ultrasonography (TVUS), which measures antral follicles (2-10 mm) of the ovaries. Both AFC and AMH were measured and correlated on days 2-4 of the same menstrual cycle. For an AMH cutoff of 1.77 ng/mL, the performance characteristics for determination of intermediate to normal ovarian reserve (defined as AFC > 15) is as follows:

 Result
Sensitivity68.3%
Specificity88.3%
Positive predictive value (PPV)75.2%
Negative predictive value (NPV)84.3%
Order Unit Code/Test Name:5786 Anti-Mullerian Hormone
Test Method:Electrochemiluminesence Immunoassay (ECLIA)
Specimen Requirements:2 mL serum. Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate. Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient, 15 to 25 °C: 3 days

Refrigerated, 2 to 8 °C: 5 days

Frozen, -15 to -25 °C: 6 months

Performed:Monday to Friday, Day Shift
Analytic Time:1 day
Reference Range:Interpretive Chart 
CPT Code:82397

Printable Version

Effective December 3rd, 2017, Clinical Pathology Laboratories will change the current instrumentation and reagents for hemoglobin A1c testing from the Roche Integra-800 A1cDX Generation 2 to Hemoglobin A1cDX Generation 3 on the Roche/Hitachi Cobas c513.

As with the current reagent, the Tina-quant Hemoglobin A1cDX Gen.3 is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Review the test information below for any changes associated with this update.

Please contact your Account Executive should you have any questions regarding this change.

Order Unit Code/Test Name:2707, 2708, and 2709
Test Method:Turbidimetric Inhibition Immunoassay (TINIA)
Specimen Requirements:4 mL EDTA Whole Blood*
Specimen Rejection Criteria:Allow on 1 Freeze/Thaw Cycle
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):3 Days Room Temperature; 1 Week Refrigerated; 6 Months Frozen
Performed:Monday through Saturday
Analytic Time:1 Day
Reference Range:4.2-5.6% A1C**
CPT Code:83036
Specimen Retention:1 Week

*Previous specimen requirement, 5 mL 

** Previous reference range, 4.0-5.6%

Printable Version

Effective September 5, 2017, Clinical Pathology Laboratories will offer in-house testing for Procalcitonin (PCT). Procalcitonin (PCT) is a(n):

  • Prohormone of the hormone calcitonin and is produced in several cell types and organs in response to inflammatory stimuli, in particular, bacterial products.1
  • Biomarker associated with the inflammatory response to bacterial infection.
  • Aid in the risk assessment of critically ill patients for progression to severe sepsis.

In healthy individuals, plasma PCT concentrations are found to be below 0.10 ng/mL. Depending on the clinical context, a PCT concentration above 0.10 ng/mL may indicate clinically relevant bacterial infection requiring antibiotic treatment. PCT levels rise rapidly (within 6 to 12 hours) after a bacterial infectious insult with systemic consequences. The magnitude of the increase in PCT concentration correlates with severity of the bacterial infection.

Procalcitonin ResultClinical Interpretation
0.10 – 0.49 ng/mL:Low risk for progression to severe systemic infection (severe sepsis). Local bacterial infection is possible.*
0.50 – 1.99 ng/mL:Moderate risk for progression to severe systemic infection (severe sepsis). Consider close monitoring and repeat assay in 6 to 24 hours.**
2.00 – 9.99 ng/mL:High risk for progression to severe sepsis.
>=10.00 ng/mL:High likelihood of severe sepsis or septic shock.

 * PCT levels below 0.5 ng/mL do not exclude an infection. Localized infections without systemic signs may be associated with such low levels. If the PCT measurement is performed very early after a bacterial challenge (usually <6 hours), these values may still be low. In this case, PCT should be reassessed 6 to 24 hours later.

Percent change of PCT over time aids in assessing cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock.

Percent change of PCT chart and equation

For convenience, one can use the Change in Procalcitonin Calculator to determine ΔPCT results from the absolute PCT concentrations of a patient obtained on the day severe sepsis or septic shock was first diagnosed (or 24 hours later) and on Day 4. Go to www.BRAHMS-PCT-Calculator.com

** Increased PCT levels may not always be related to systemic bacterial infection. This includes neonates <48 hours of life, first days after major trauma, surgery, burns, invasive fungal or plasmodium infections, cardiogenic shock, severe liver cirrhosis, and certain malignancies (lung and thyroid).

Order Unit Code/Test Name:4709 Procalcitonin
Test Method:Electrochemiluminescent Immunoassay (ECLIA)
Specimen Requirements:2 mL serum. Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate. Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):Ambient, 15 to 25 °C: 24 hours Refrigerated, 2 to 8 °C: 6 days Frozen, -15 to -25 °C: 3 months
Performed:Monday to Friday, Day Shift
Analytic Time:1 day
Reference Range:<0.10 ng/mL
CPT Code:84145

Reference: 1. Christ-Crain M, Müller B. Procalcitonin in bacterial infections-hype, hope, more or less? Swiss Med Wkly 2005 Aug 6;135(31-32):451-460.

Printable Version

Effective April 24, 2017, Clinical Pathology Laboratories will offer in-house testing for NT-proBNP as a replacement for current BNP testing.

Atrial- and brain-type natriuretic peptides (ANPs and BNPs) are produced in cardiac tissues in response to ventricular dysfunction and atrial distension.

NT-proBNP aids in the:

  • Diagnosis and prognosis of individuals suspected of having congestive heartfailure
  • Risk stratification of patients with acute coronary syndrome and congestive heart failure
  • Assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease

NT-proBNP, in contrast to Brain Natriuretic Peptide (BNP), is:

  • Unaffected by the new class of Neprilysin Inhibitors (e.g. Entresto®)
  • Suitable as a Biomarker for congestive heartfailure
  • Stable when collected, stored and transported at Ambient, Refrigerated and Frozen Temperatures 

 The table below demonstrates NT-proB performance characteristics by agerange.

 MaleFemale
Age in years45-54 55-6465-74≥ 7545-5455-6465-74≥ 75
% Sensitivity88.269.691.786.590.589.394.381.8
% Specificity93.387.886.788.985.579.957.887.9
% Prevalence1.86.26.89.81.33.46.69.7
% NPV99.899.299.398.899.999.599.397.8

In-house testing for BNP (unit code 5585) will be discontinued May 10, 2017. Please contact your Sales Representative should you have any questions regarding this change.

Order Unit Code/Test Name:5722 NT-proBNP
Test Method:Electrochemiluminescence Immunoassay (ECLIA)
Specimen Requirements: 2 mL serum. Allow Serum Separator Tube (SST) to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate (2-8 °C) Note: Samples should not be collected from patients receiving therapy with high Biotin doses (> 5 mg/day) until at least 8 hours following the last Biotin administration
Specimen Rejection Criteria:Grossly hemolyzed specimens will be rejected
Transport Temperature: Refrigerated (2-8 °C)
Stability (collection to initiation of testing:Ambient (15-25 °C) - 3 days; Refrigerated (2-8 °C) - 6 days: Frozen (≤ -20 °) - 1 month 
Performed:Monday –Friday 
Analytic Time:1 day
Reference Range:

< 75 years: 124 pg/mL or less

≥ 75 years: 449 pg/mL or less

CPT Code:83880

Printable Version

Dear CPL Client:

Effective March 10, 2017, testing for Unit code 5949, cardiac Troponin I (cTnI) was discontinued due to analytic unavailability of Troponin I testing.

Unit Code 4017, high sensitivity (hs) cardiac Troponin T (cTnT) has been validated on the Roche cobas® platform as an Electrochemiluminescent Immunoassay (ECLIA) and both current and future orders will be migrated to Troponin T.

Gimenez MR, et. al. measured the diagnostic and prognostic accuracy of cTnT and cTnI using clinically available high sensitivity assays (Roche hs-cTnT vs. Abbott hs-cTnI). Patients at presentation, early presenters (< 3 hours since onset of chest pain), late presenters and prognostic accuracy were evaluated.

The findings demonstrated:

  • Diagnosis at presentation performance was similar for both hs-cTnT and hs-cTnI.
  • Diagnosis of early presenters showed slightly higher accuracy for hs-cTnI.
  • Diagnosis of late presenters showed superior performance for hs-TnT.
  • Prognostic accuracy for all-cause mortality was significantly higher for hs-cTnT.

Diagnostic performance of high-sensitivity cardiac troponins I and T.

 Diagnostic performance of high-sensitivity cardiac troponins I and T. Receiver-operation-characteristic curves show the diagnostic accuracy of high-sensitivity cardiac troponins I and T for non-ST segment myocardial infarction at presentation to the emergency department with acute chest pain in the overall cohort (A) and in the patients with a chest pain onset within 3 h (B). 

Diagnostic performance of high-sensitivity cardiac troponin T and I within time.

 Diagnostic performance of high-sensitivity cardiac troponin T and I within time. Receiver-operation-characteristic curves displaying the diagnostic accuracy for non-ST segment myocardial infarction of serial sampling of high-sensitivity cardiac troponin I vs. high-sensitivity cardiac troponin T. 

Prognostic performance of high-sensitivity cardiac troponin T and I.

 Prognostic performance of high-sensitivity cardiac troponin T and I. Receiver-operation-characteristic curves displaying the prognostic accuracy for all-cause mortality during the 24-month follow-up of high-sensitivity cardiac troponin I and high sensitivity cardiac troponin T. 

Print Version

ZIKA Fact Sheets for Health Care Providers and Patients Offering our clients state-of-the-art testing is part of CPL’s ongoing commitment to excellence

Effective 12/30/2016, Clinical Pathology Laboratories (CPL) will offer Zika Virus, PCR Serum and Urine and Zika Virus Antibody, IgM.

Etiology Zika virus is an emerging zoonotic viral disease that has been identified as a causative agent of microcephaly and other severe brain defects.

The Zika virus:

  • Is primarily spread to people through mosquito bites
  • can be transmitted through blood transfusion or sexual contact
  • can be spread from mother to child

Signs and Symptoms

Most people infected with the virus have mild or no symptoms. For those who do develop symptoms, illness is generally mild and typically lasts a few days to a week. The most common symptoms are fever, rash, joint pain, and conjunctivitis. Infections requiring hospitalization are uncommon and fatalities are rare; however, the disease may be associated with an increased risk of Guillain-Barré syndrome.

Guidelines for testing

Testing should only be performed in individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical and/or epidemiological criteria:

  • Clinical signs and symptoms associated with Zika virus infection
  • History of residence in, or travel to a geographic regions with active Zika transmission at the time of travel
  • Other epidemiologic criteria for which Zika virus testing may be indicated i.e. sexual transmission Additional information can be found at: http://www.cdc.gov/zika/symptoms/index.html

Interpretive Information

  • The tests have not been FDA cleared or approved The tests have been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories
  • The tests have been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, and not for any other viruses or pathogens
  • The tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Order Unit Code/Test Name:3113 ZIKA Virus Serum and Urine
Specimen Requirements:

3 mL serum in each of 2 plastic transport
tubes. Clearly label transport tubes as serum.
Freeze. When multiple tests are ordered
submit separate tubes for this test.
A completed Zika Testing History form
must accompany sample.

3 mL random urine in plastic transport tube.
Clearly label transport tube as urine. Freeze.
When multiple tests are ordered submit
separate tubes for this test.

Rejection CriteriaRoom temperature samples No serum sample received.
Transport Temperature:Frozen (≤ -20 ◦ C)
Stability:Room Temperature Unacceptable
Refrigerated: (2-8 ◦ C) 1 week
Frozen: (≤ -20 ◦ C) 2 weeks
Preformed:Monday - Friday
Analytic Time:2-3 Days
Reference Range:Negative
CPT Code:87798 x2

Printable ZIka Testing Form

ZIka Testing Algorithms

Signs/SymptomsClinical IndicationsPregnantNon-Pregnant
Symptomatic<14 days from symptom onsetAlgorithm 1Algorithm 1
Symptomatic2-12 weeks from symptom onsetAlgorithm 3Algorithm 2
Asymptomatic<14 days after return from travel or exposureAlgorithm 4No guidance*
Asymptomatic2-12 weeks from return from travel or exposureAlgorithm 5No guidance*

* No specific algorithm or guidance is published by the Centers for Disease Control and Prevention (CDC) for this clinical indication. Testing should be individualized as appropriate.

List of Algorithms

Dear Madam:

You are being given this Fact Sheet, because your blood or urine was tested for evidence of Zika virus infection. This testing is being done because you have symptoms of Zika virus infection and you live in or have traveled to an area with active Zika virus transmission, or you have a male sex partner who has lived in or traveled to an area with ongoing Zika virus transmission. The test used on your specimen(s) is called the RealStar® Zika Virus RT-PCR Kit U.S., which is a laboratory test designed to help detect Zika virus infection in humans.

This Fact Sheet contains information to help you understand the risks and benefits of using the RealStar® Zika Virus RT-PCR Kit U.S. You may want to discuss with your health care provider the benefits and risks described in this Fact Sheet and any additional questions you may have.

Zika virus infection is caused by the Zika virus and is most often spread to people through mosquito bites. A woman infected with Zika virus during pregnancy can pass the virus to her unborn baby. Zika virus can also be sexually transmitted by a man to his sexual partners. Since 2015, a large number of Zika virus cases have been reported in many South and Central American countries.

Most people who are infected with Zika virus do not have any symptoms. Those that do, usually have mild illness with symptoms that may include fever, joint pains, rash, or redness of the eyes. These symptoms often resolve on their own within a week.

Although the Centers for Disease Control and Prevention (CDC) is still investigating the potential harms from Zika virus infection, it has concluded that there is enough scientific evidence to state that Zika virus infection during pregnancy is a cause of birth defects (such as microcephaly) and other poor pregnancy outcomes. Zika virus infection in a pregnant woman does not definitely mean she will have pregnancy problems. However, a woman who is infected with Zika virus during pregnancy is at increased risk of miscarriage, having a baby that is stillborn, or having a baby that is small at birth, has incomplete brain development (microcephaly), and/or eye problems. Women who get Zika virus infection while pregnant should be monitored more closely by their healthcare providers throughout their pregnancy. There have also been reports of a possible link between Zika virus infection and an illness that can cause temporary paralysis (Guillain-Barré syndrome).

The RealStar® Zika Virus RT-PCR Kit U.S. is a laboratory test designed to detect Zika virus. The Food and Drug Administration (FDA) has not cleared or approved this test. No FDA-cleared or approved tests exist that can tell whether you have Zika virus infection. However, FDA has authorized the use of this test under an Emergency Use Authorization (EUA).

You were tested because you have symptoms that resemble Zika virus infection and because you live in or have traveled to an area with active Zika virus transmission or have a male sex partner who has lived in or traveled to an area with active Zika virus transmission. The sample collected from you was tested using the RealStar® Zika Virus RT-PCR Kit U.S. to help find out whether you may be infected with Zika virus. The test results, along with other information, could help your doctors make decisions about how to take care of you and better monitor your pregnancy.

You may feel discomfort when the sample is taken. There is a very small chance that the test result is incorrect (see next paragraphs for more information). The results of this test, along with other information, can help your health care provider make decisions about how to take care of you and your baby. 

If you have a positive test, it is very likely that you have a Zika virus infection. There is a very small chance that this test can give a positive result that is wrong; this is called a “false positive” result. If your result from this test is positive, your health care provider or health department will work with you to help you understand the steps you should take to care for yourself. They will also work closely with you to monitor the health and development of your baby.

No, not necessarily. While, evidence shows that Zika virus infection during pregnancy is a cause of birth defects and other poor pregnancy outcomes, not all Zika virus infections result in these pregnancy problems. This test result may lead your doctors to follow your pregnancy more closely, however, a Zika virus infection in a mother does not always mean the baby will be harmed. 

 

 

 

Roche Immunoassay Reference Ranges

Effective November 14, 2016

Clinical Pathology Laboratories (CPL) will change the current immunochemistry instrumentation and reagents to Roche COBAS® Electrochemiluminescent (eCLIA) methodology. As a result of this change, all related reference ranges are reviewed. Ranges for certain analytes are modified in the validation process, and additional interpretive notes or information are added for selected assays. Gender and age stratification is applied as appropriate. The chart below summarizes all analytes to be performed on Roche COBAS® eCLIA. Laboratory reports will be appended with a notice. As always, please review your laboratory results in the context of the provided reference interval and flagging.

Please contact your Account Executive should you have any questions regarding this change.

2645CEA   0.0-3.8ng/mL
    Otherwise healthy smokers0.0-5.5ng/mL
2070CKMBMale  ≤ 7.7ng/mL
  Female  ≤ 4.3ng/mL
  Not given  ≤ 4.3ng/mL
2655Cortisol   4.8-19.5µg/dL
4267Cortisol, AM  AM (6-10 am)4.8-19.5µg/dL
4269Cortisol, PM  PM (4-8 pm)2.5-11.9µg/dL
3034Digoxin   0.6-2.0ng/mL
2675EstradiolMale≥18yrs. 25.8-60.7pg/mL
  Female≥18yrs.Follicular12.4-233.0pg/mL
  Female Ovulation41.0-398.0pg/mL
  Female Luteal22.3-341.0pg/mL
  Female Post-menopausal< 138.0pg/mL
  Female 1st Trimester154-3,243pg/mL
  Female 2nd Trimester1,561-21,280pg/mL
  Female 3rd Trimester8,525->30,000pg/mL
  Male7-9yrs. ≤ 17.0pg/mL
  Male10-12yrs. ≤ 18.0pg/mL
  Male13-15yrs. ≤ 51.0pg/mL
  Male16-17yrs. ≤ 48.0pg/mL
  Male Tanner I≤ 17.0pg/mL
  Male  Tanner II≤ 17.0pg/mL
  Male  Tanner III≤ 49.0pg/mL
  Male  Tanner IV/V≤ 49.0pg/mL
  Female7-9yrs. ≤ 51.0pg/mL
  Female10-12yrs. ≤ 116.0pg/mL
  Female13-15yrs. ≤ 324.0pg/mL
  Female16-17yrs. ≤ 346.0pg/mL
  Female Tanner I≤76.0.0pg/mL
  Female Tanner II≤ 175.0pg/mL
  Female Tanner III20.0-360.0pg/mL
  Female Tanner IV/V≤ 337.0pg/mL
2090FerritinMale 0-1 mo. 25-200ng/mL
  Male 2-5 mos 50-200ng/mL
  Male 6 mos.-15yrs. 7-140ng/mL
  Male 16-150yrs. 30-400ng/mL
  Female0-1 mo. 25-200ng/mL
  Female2-5 mos. 50-200ng/mL
  Female6 mos.-15yrs. 7-140ng/mL
  Female16 – 15yrs. 13-200ng/mL
2695Folic AcidFemale  ≥ 6.0µg/L
2700FSHMale ≥18yrs. 1.5-12.4IU/L
  Female≥18yrs.Follicular3.5-12.5IU/L
  Female Mid-Cycle4.7-21.5IU/L
  Female Luteal1.7-7.7IU/L
  Female Post-Menopausal25.8-134.8IU/L
  Male 4 wks.-5mos. 0.2-4.1IU/L
  Male 6 mos.-2yrs. 0.3-2.2IU/L
  Male 3-4yrs. 0.3-2.3IU/L
  Male 5-6yrs. 0.3-2.0IU/L
  Male 7-9yrs. 0.3-2.6IU/L
  Male 10-12yrs. 0.5-4.9IU/L
  Male 13-15yrs. 1.1-7.4IU/L
  Male 16-17yrs. 0.9-7.8IU/L
  Male  Tanner I0.3-2.9IU/L
  Male  Tanner II0.4-4.8IU/L
  Male  Tanner III1.0-6.6IU/L
  Male  Tanner IV/V1.0-8.2IU/L
  Female4 wks.-5mos. 0.2-14.2IU/L
  Female6 mos.-2yrs. 1.4-8.0IU/L
  Female3-4yrs. 0.6-5.0IU/L
  Female5-6yrs. 0.5-3.2IU/L
  Female7-9yrs. 0.4-4.4IU/L
  Female10-12yrs. 0.7-8.3IU/L
  Female13-15yrs. 1.0-9.1IU/L
  Female16-17yrs. 0.4-9.9IU/L
  Female Tanner I0.4-6.5IU/L
  Female Tanner II1.0-8.4IU/L
  Female Tanner III1.0-9.5IU/L
  Female Tanner IV/V0.6-9.4IU/L
2713HCGMale   0-5mIU/mL
  Female Non-pregnant0-5mIU/mL
  Female Post-menopausal≤ 7mIU/mL
  Female GA 3 weeks   Female GA 4 weeks10-750mIU/mL
  Female GA 5 weeks217-7,138mIU/mL
  Female GA 6 weeks158-31,795mIU/mL
  Female GA 7 weeks3,697-163,563mIU/mL
  Female GA 8 weeks32,065-149,571mIU/mL
  Female GA 9 weeks63,803-151,410mIU/mL
  Female GA 10 weeks46,509-186,977mIU/mL
  Female GA 12 weeks27,832-210,612mIU/mL
  Female GA 14 weeks13,950-62,530mIU/mL
  Female GA 15 weeks12,039-70,971mIU/mL
  Female GA 16 weeks9,040-56,451mIU/mL
  Female GA 17 weeks8,175-55,868mIU/mL
  Female GA18 weeks8,099-58,176mIU/mL
2776LHMale ≥18yrs. 1.2-8.6IU/L
  Female≥18yrs.Follicular2.4-12.6IU/L
  Female Mid-Cycle14.0-95.6IU/L
  Female Luteal1.0-11.4IU/L
  Female Post-Menopausal7.7-58.5IU/L
  Male 7-9yrs. 0.0-0.7IU/L
  Male 10-12yrs. 0.0-3.4IU/L
  Male 13-15yrs. 0.3-5.6IU/L
  Male 16-17yrs. 1.1-9.0IU/L
  Male  Tanner I0.0-1.0IU/L
  Male  Tanner II0.0-3.6IU/L
  Male  Tanner III0.2-6.4IU/L
  Male  Tanner IV/V1.1-8.5IU/L
  Female7-9yrs. 0.0-0.7IU/L
  Female10-12yrs. 0.0-6.8IU/L
  Female13-15yrs. 0.0-23.0IU/L
  Female16-17yrs. 0.0-26.4IU/L
  Female Tanner I0.0-2.8IU/L
  Female Tanner II0.0-7.9IU/L
  Female Tanner III0.0-23.0IU/L
  Female Tanner IV/V0.0-25.3IU/L
2790ProgesteroneMale   < 0.15ng/mL
  Female Follicular0.06-0.89ng/mL
  Female Ovulation0.12-12.00ng/mL
  Female Luteal1.83-23.90ng/mL
  Female Post-Menopausal< 0.13ng/mL
  Female 1st Trimester11.00-44.30ng/mL
  Female 2nd Trimester25.40-83.30ng/mL
  Female 3rd Trimester58.70-214.0ng/mL
2800ProlactinMale   4.0-15.2ng/mL
  Female Non-pregnant4.8-23.3ng/mL
2690RBC Folate   499-1504ng/mL
4600Rubella IgG  Reactive≥ 10IU/mL
2991SHBGMale 1-7 days 12.3-46.2nmol/L
  Male 8-15 days 16.2-60.7nmol/L
  Male 16 days – 3yrs. 21.1-97.5nmol/L
  Male 4-6yrs. 32.9-119.1nmol/L
  Male 7-8yrs. 39.8-102.3nmol/L
  Male 9-10yrs. 29.6-141.6nmol/L
  Male 11yrs. 43.0-129.1nmol/L
  Male 12yrs. 30.0-145.3nmol/L
  Male 13yrs. 23.6-133.5nmol/L
  Male 14yrs. 16.9-86.4nmol/L
  Male 15yrs. 19.5-120.3nmol/L
  Male 16yrs. 19.6-96.5nmol/L
  Male 17yrs. 21.0-67.6nmol/L
  Male 18-20yrs. 14.5-56.2nmol/L
  Male 21-49yrs. 16.5-55.9nmol/L
  Male ≥ 50yrs. 19.3-76.4nmol/L
  Female1-7 days 11.1-33.3nmol/L
  Female8-15 days 13.3-46.6nmol/L
  Female16 days – 3yrs. 15.6-83.2nmol/L
  Female4-6yrs. 39.4-110.7nmol/L
  Female7-8yrs. 38.9-125.7nmol/L
  Female9-10yrs. 29.7-148.9nmol/L
  Female11yrs. 33.3-132.7nmol/L
  Female12yrs. 29.8-121.5nmol/L
  Female13yrs. 25.5-134.3nmol/L
  Female14yrs. 16.0-113.6nmol/L
  Female15yrs. 25.4-130.1nmol/L
  Female16yrs. 27.7-137.8nmol/L
  Female17yrs. 24.4-109.4nmol/L
  Female18-20yrs. 23.5-124.9nmol/L
  Female21-49yrs. 24.6-122.0nmol/L
  Female≥ 50yrs. 17.3-125.0nmol/L
4017Troponin T   <0.010µg/L
2830TestosteroneMale 10-11yrs. ≤ 150ng/dL
  Male 12-13yrs. ≤ 561ng/dL
  Male 14-15yrs. 28-664ng/dL
  Male 16-17yrs. 143-749ng/dL
  Male  Tanner I≤ 14ng/dL
  Male  Tanner II≤ 275ng/dL
  Male  Tanner III≤ 771ng/dL
  Male  Tanner IV/V147-768ng/dL
  Male 18-39yrs. 300-1080ng/dL
  Male 40-59yrs. 300-890ng/dL
  Male ≥60yrs. 300-720ng/dL
  Female10-11yrs. ≤ 29ng/dL
  Female12-13yrs. ≤ 45ng/dL
  Female14-15yrs. ≤ 47ng/dL
  Female16-17yrs. ≤ 53ng/dL
  Female Tanner I≤ 15ng/dL
  Female Tanner II≤ 36ng/dL
  Female Tanner III≤ 57ng/dL
  Female Tanner IV/V≤ 56ng/dL
  Female18-59yrs. < 50ng/dL
  Female≥ 60yrs. < 29ng/dL
N/ATestosterone,Male 10-11yrs. ≤ 0.6ng/dL
 FreeMale 12-13yrs. ≤ 10.3ng/dL
  Male 14-15yrs. 0.2-14.5ng/dL
  Male 16-17yrs. 3.9-18.2ng/dL
  Male  Tanner I≤ 0.3ng/dL
  Male  Tanner II≤ 2.1ng/dL
  Male  Tanner III≤ 10.3ng/dL
  Male  Tanner IV3.6-17.8ng/dL
  Male  Tanner V4.2-25.2ng/dL
  Male ≥ 18yrs. 4.8-25.7ng/dL
  Female10-11yrs. ≤ 0.3ng/dL
  Female12-13yrs. ≤ 0.6ng/dL
  Female14-15yrs. ≤ 0.7ng/dL
  Female16-17yrs. ≤ 1.0ng/dL
  Female Tanner I≤ 0.1ng/dL
  Female Tanner II≤ 0.4ng/dL
  Female Tanner III0.1-0.7ng/dL
  Female Tanner IV≤ 1.6ng/dL
  Female Tanner V≤ 0.9ng/dL
  Female18-30yrs. ≤ 0.7ng/dL
  Female31-40yrs. ≤ 0.9ng/dL
  Female41-51yrs. ≤ 0.5ng/dL
  Female≥ 52yrs. ≤0.3ng/dL
2606Total PSAMale   ≤ 4.00ng/mL
2613Total PSA,Age-AdjustedMale ≤ 30yrs.    Male 31-32yrs. < 1.40ng/mL
  Male 33-34yrs. < 1.60ng/mL
  Male 35-36yrs. < 1.70ng/mL
  Male 37-38yrs. < 1.80ng/mL
  Male 39-40yrs. < 1.90ng/mL
  Male 41yrs. < 2.00ng/mL
  Male 42-43yrs. < 2.20ng/mL
  Male 44yrs. < 2.30ng/mL
  Male 45-46yrs. < 2.40ng/mL
  Male 47yrs. < 2.50ng/mL
  Male 48yrs. < 2.60ng/mL
  Male 49-50yrs. < 2.80ng/mL
  Male 51yrs. < 2.90ng/mL
  Male 52yrs. < 3.00ng/mL
  Male 53yrs. < 3.10ng/mL
  Male 54yrs. < 3.30ng/mL
  Male 55yrs. < 3.40ng/mL
  Male 56yrs. < 3.50ng/mL
  Male 57yrs. < 3.60ng/mL
  Male 58yrs. < 3.70ng/mL
  Male ≥ 59yrs. < 4.00ng/mL
2840Vitamin B-12   200-950pg/mL

Printable Version

Attention: CPL Clients

Reminder: ICD-10-CM, the International Classification of Diseases 10th Revision

Compliance Date: October 1, 2015

This rule applies to:

  • Health Care Providers
  • Health Plans
  • Health Care Clearinghouses

The rule requires:

  • Use of ICD-10-CM beginning October 1, 2015
  • Continued use of ICD-9-CM through September 30, 2015
  • Providers, insurance companies and others in the health care industry to ensure their systems and business processes are ready for the October 1, 2015 compliance date

 Further detailed announcements and answers to Frequently Asked Questions about CPL’s ICD-10-CM implementation will be issued over the next few months.

Please watch for CPL announcements regarding:

  • CMS National Coverage Determinations (NCDs) for laboratory testing
  • Noridian Local Coverage Determinations (LCDs) for laboratory testing
  • Novitas Local Coverage Determinations (LCDs) for laboratory testing
  • Patient Orders placed on or before October 1, 2015
  • Standing Orders placed on or before to October 1, 2015

For additional information and resources visit the:

Printable Version

 

Enterovirus EV-D68

Clinical Pathology Laboratories (CPL) does not currently offer testing for Enterovirus with specific typing for EV-D68, but offers an Enterovirus by PCR screening test that does not include typing (order code 5080; see below for details). 

Enterovirus testing with D68 typing:

  • Is only available from the US Centers for Disease Control and Prevention (CDC). For current clinical and testing information from the CDC, see http://www.cdc.gov.
  • May not be as timely as that performed in a clinical laboratory.
  • Can only be accepted when submitted through state or local health departments for epidemiological purposes. Questions must be directed through local or state health departments as follows:

Texas

Texas Department of State Health Services: https://www.dshs.state.tx.us Emerging and Acute Infectious Disease Branch: 512.776.7676 or 800.252.8239

Louisiana

Louisiana Department of Health and Hospitals: http://www.dhh.state.la.us Infectious Disease/Epidemiology: 800.256.2748

New Mexico

New Mexico Department of Health: http://nmhealth.org Epidemiology and Response: 505.827.0006

Nevada

Southern Nevada Health District: http://www.southernnevadahealthdistrict.org Office of Epidemiology: 702.759.1300
Note: Southern Nevada Health District services only residents of Southern Nevada

Oklahoma

Oklahoma State Department of Health: http://www.ok.gov/health
Acute Disease: 405.271.4060 Ask to be connected to the Epidemiologist on Call

Order Unit Code/Test Name:5080 – Enterovirus by PCR
Specimen Requirements:
  • 2 mL bronchial lavage or wash or nasal wash in sterile leak-proof container
  • nasopharyngeal or throat swab in viral transport media
Transport Temperature:Frozen
Maximum Lab Time:3-4 days

Printable Version

Ebola Virus

Ebola virus disease (EVD) is one of number of viral hemorrhagic fevers (VHF). It is a severe, often fatal disease in human and nonhuman primates. Ebola virus is spread by direct contact with the blood or body fluids (such as urine, saliva, feces, vomit and semen) of an infected and symptomatic person or by being exposed to objects that have been contaminated with infected blood or body fluids. The incubation period is usually 8–10 days (rarely ranging from 2 to 21 days). Patients can transmit the virus once symptoms appear and through the later stages of disease, as well as postmortem.

If you are considering a diagnosis of EVD, you should first review the US Centers for Disease Control and Prevention (CDC; website: http://www.cdc.gov) criteria and case definition for EVD. If the patient is still considered suspect for EVD, you must contact your local Health Department (see below). Specimens from the patient would then be collected and processed under the direction of the local or state Health Department. The CDC testing cannot be referred from nongovernmental laboratories.

CPL does not collect, process or analyze specimens for EVD testing or to rule out EVD infection. Please do not submit specimens to CPL for any other testing such as hematology, chemistry or microbiology from patients suspected to have EVD or for whom EVD is a clinical consideration until those individuals have been cleared by state Health Departments or the CDC. In the interest of safety and adherence to national and state EVD requirements, CPL requests that providers or patients inform us if the patient has recently traveled to endemic areas or has been exposed to affected areas prior to acquiring specimens.

For the most current information and updates, please see the Centers for Disease Control and Prevention (CDC) website: http://www.cdc.gov

Questions can also be directed to your local Health Departments.

Texas

Texas Department of State Health Services: https://www.dshs.state.tx.us Emerging and Acute Infectious Disease Branch: 512.776.7676 or 800.252.8239

Louisiana

Louisiana Department of Health and Hospitals: http://www.dhh.state.la.us Infectious Disease/Epidemiology: 800.256.2748

New Mexico

New Mexico Department of Health: http://nmhealth.org Epidemiology and Response: 505.827.0006

Nevada

Southern Nevada Health District: http://www.southernnevadahealthdistrict.org Office of Epidemiology: 702.759.1300 Note: Southern Nevada Health District services only residents of Southern Nevada

Oklahoma

Oklahoma State Department of Health: http://www.ok.gov/health Acute Disease: 405.271.4060 Ask to be connected to the Epidemiologist on Call

Printable Version

On February 6, 2014, The Department of Health and Human Services (HHS) issued modifications to the HIPAA privacy rule, entitled “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports”. The rule can be viewed in its entirety at: http://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02280.pdf

The provisions of the rule include:

  • A patient or authorized patient representative has the right to receive completed laboratory reports directly from any CLIA certified laboratory.
  • Patients/representatives may request current or prior reports. The duration of record retention is variable and meets the specifications of the Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and CMS.
  • Report delivery must be in the form and format requested by the patient/representative if a copy in that form or format is readily producible.
  • Report must be issued to the patient/representative within 30 days of request unless preempted by state law. In the states of Texas and Louisiana, records must be provided within 15 days of the written request. The rule provides sufficient time to allow a treating provider to receive a test report in advance of the patient’s receipt of the report and to communicate the result to and counsel the patient as necessary.
  • The laboratory is not required to provide clinical interpretation of results to patient/representative.
  • There is no routine exclusion or refusal to release “sensitive tests” to patients unless a licensed healthcare professional specifically renders a judgment that the information is “reasonably likely to endanger the life or physical safety of the individual or another person”. 

 CPL’s responses to the provisions of the rule include:

 An authentication process for release of patient results to include a Record Request Form with instructions for completion and submission (see reverse).

 A secure method of report delivery to patients/representatives in form/format requested.

 Updated Notice of Privacy Practices (NPP) reflecting patient/representative right to access completed laboratory reports.

 A new order code for use by providers when they believe results are “reasonably likely to endanger the life or physical safety of the individual or another person”. Order code 813, Patient Record Request Review holds results from release directly to patients. The code may be ordered manually or electronically with specimen collection and submission or verbally added after specimen is submitted to the laboratory. CPL will monitor use of order code 813 to make sure it is not routinely used to prevent result release.

 CPL will not provide clinical interpretation of laboratory results to patients or their representatives.

I welcome any questions that you have and appreciate your support.

Sincerely,

Mark A. Silberman, M.D.

Laboratory Director

Email: msilberman@cpllabs.com phone: 512.873.1603

Printable Version

Effective immediately, CPL is excited to announce that we have entered into a new long-term agreement with UHC that allows us to continue providing laboratory services to members of all UHC plans: Commercial, Medicare, and Community Plans. 

CPL remains a committed partner with UHC in our efforts to bring the highest quality and most cost-efficient services to all UHC covered members.

CPL has over 200 Patient Service Centers located throughout the southwestern United States to serve you and your patients.

As a reminder, if you refer testing to a laboratory that does not participate in the UHC network, your members may be subject to a higher healthcare cost as described in their benefit plans for out-of-network services.

If you have any questions regarding CPL’s insurance contracts or locations,  or call your Account Executive at 800.595.1275.

Printable Version

Client Communication

9200 Wall Street, Austin, TX 78754                                                                Issued December, 2010

Specimen Collection and Preperation

Report Comment on Unspun Vacutainer SST Samples

In a continuing effort to ensure the quality of all specimens recieved for testing, we would like to remind our clients of the necessity of proper centrifugation of specimens submitted in serum seperator tubes(SSTs).

It is essential that the serum in a blood specimen be seperated from the cells within 2 hours of collection. However, the blood specimen must be allowed to properly clot prior to centrifugation. Please adhere to the following procedure:

1. SST tubes must properly clot prior to centrifugation in an upriht position for 30 minutes. Centrifugation is required within 2 hours.

2. Centrifuge tubes for 15 minutes when using an angle head centrifuge. If the centrifuge does not have a timer, watch time carefully to avoid over or under centrifuging.
NOTE:
Do not re-centrifuge specimens in the SST tubes after the initial spin. 

3. If you are collecting the specimens, you are responsible for proper processing.

Prolonged unspun SSTs will artificially increase potassium and LDH and decrease glucose. The effect of delayed centrifugation can affect a broad variety of other lab tests. The laboratory will begin adding a comment to the report for various analytes disclosing the possibility that results may be affected by improper handling based on Clinical Laboratory Standards Institute guidelines*.

(* Kiechele FL et. al. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests-Fourth Edition Vol. 30, No. 10, CLSI May 2010)

Thank you for supporting Clinical Patology Laboratories, Inc.

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