Effective May 19, 2020, Interpath Laboratory is offering in-house testing for antibodies against SARS-CoV-2, the etiologic agent of coronavirus disease 2019 (COVID-19). The Interpath Laboratory “Anti-SARS-CoV-2 Ab (IgM + IgG)” test (#2870) is a total antibody test, detecting IgM + IgG antibodies, as is currently recommended by the U.S. Centers for Disease Control and Prevention (CDC).
Recent studies1,2,3 have shown some utility for antibody tests as supplements (not stand-alone) to the NAATs in diagnosing late acute (active) COVID-19. However, due to the highly variable performance (e.g., sensitivity, specificity) of the multitude of assays that have been developed, we have chosen a test that has been granted emergency use authorization (EUA) designation by the U.S. Food and Drug administration (FDA).
In addition, we continue to offer “SARS-CoV-2 by PCR” (test #2785), a nucleic acid amplification test (NAAT) which remains the recommended test type for diagnosis of acute (active) COVID- 19. Even as testing capacity continues to increase, we recommend that clinicians continue to work closely with local and state public health officials and follow CDC guidelines to determine prioritization of patients to be tested (https://www.cdc.gov/coronavirus/2019- nCoV/hcp/clinical-criteria.html).
Interpath is contracted with public and private payers and will bill those payers for the cost of COVID testing. Patients will not incur upfront out of pocket costs for the test.
Interpath’s price for cash-paying patients:
COVID-19 molecular diagnostic testing = $100.00
COVID-19 IgG serological antibody testing = $63.00
2870 Anti-SARS-CoV-2 IgM and IgG NT |
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Specimen: |
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Collect: |
One SST Also Acceptable |
Submit: |
1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Also Acceptable |
Rejection Criteria: |
Heat inactivated |
Stability: |
Ambient: 3 Day(s); Refrigerated: 7 Day(s); Frozen: 4 Week(s); Incubated: Unacceptable |
Methodology: |
Electrochemiluminescence Immunoassay (ECLIA) |
Performed: |
Mon-Fri |
Reported: |
1-3 Day(s) |
Interpretive Data: |
General Reference Range : non-reactive This test cannot be used by itself to diagnose an acute infection. Testing with a molecular diagnostic method (e.g., SARS-CoV-2 by PCR) should be performed to evaluate for active infection. It is not known at this time if the presence of antibodies to SARS- CoV-2 confers immunity to reinfection. The individual immune response following SARS-CoV-2 infection (COVID-19) varies considerably and might give different results with assays from different manufacturers. Results of assays from different manufacturers should not be used interchangeably. FOR INFORMATION ABOUT THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE EMERGENCY USE OF THIS SARS-COV-2 (COVID-19) ANTIBODY TEST, GO TO: www.fda.gov/media/137603/download (FOR HEALTHCARE PROVIDERS), OR: www.fda.gov/media/137604/download (FOR PATIENTS). |
Watch our website for the date when COVID-19 Antibody testing will be available.
Interpath is now offering a COVID 19 self collection kit that contains one sterile Polyester tipped swab, a specimen transport tube and patient self-collection instructions. Kit is available through our E supply process using item number #105137.
We are working closely with federal and state authorities, health officials, and other key constituencies to make testing available to all patients who meet CDC criteria for who should be tested. We are also encouraging the use of the Department of Health and Human Services (HHS) guidance for prioritization of testing, while we work to increase test capacity in response to this public health crisis. Our priority is the health and safety of our patients, employees, and the communities we serve
Note 1. Supplies to collect and test COVID19 specimens remain at National shortage levels. We are working to maintain levels of those supplies to be able to provide testing as requested.
Note 2. Additional information on COVID-19 testing can be found in the “Latest News” section on the homepage of our website. www.interpathlab.com
Specimen: | |
Collect: | Nasopharyngeal Swab in Viral Transport Media Also Acceptable Nasopharyngeal Swab in Sterile Tube w/Saline Throat Swab in Viral Transport Media Throat Swab in Sterile Tube w/Saline |
Submit: | Nasopharyngeal Swab in Viral Transport Media. Submit Frozen. Also Acceptable Nasopharyngeal Swab in Sterile Tube w/Saline. Submit Frozen. Throat Swab in Viral Transport Media. Submit Frozen. Throat Swab in Sterile Tube w/Saline. Submit Frozen. |
Special Handling: | Swab must be placed in VTM or Saline within 1 hour of collection. |
Rejection Criteria: | Swab not placed in VTM or Saline within 1 hour of collection. Calcium alginate swabs, cotton swabs, or swabs with wooden shafts. |
Stability: | Ambient: Unacceptable; Refrigerated: 4 Day(s); Frozen: 2 Week(s); Incubated: Unacceptable |
Methodology: | Real-Time Polymerase Chain Reaction |
Performed: | Mon-Fri |
Reported: | 1-4 Day(s) |
Interpretive Data: | General Reference Range: negative THIS IS A REAL-TIME PCR ASSAY FOR THE RAPID AND PRESUMPTIVE QUALITATIVE DETECTION OF RNA FROM SARS-COV-2 (ETIOLOGICAL CAUSE OF COVID-19). POSITIVE RESULTS ARE INDICATIVE OF ACTIVE INFECTION WITH SARS-COV-2, BUT DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS. FOR INFORMATION ABOUT THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE EMERGENCY USE OF THIS SARS-COV-2 (COVID-19) TEST, GO TO: www.fda.gov/media/136599/download (FOR HEALTHCARE PROVIDERS), OR: www.fda.gov/mwww.fda.gov/media/136600/downloadedia/136600/download (FOR PATIENTS). |
Test results are reported to our clients as “positive,” “negative,” or “invalid.”
Interpath considers a result of “positive” to be a critical value, and as with all critical values, the result will be called to the client.
All COVID-19 test results (both positive and negative) will be reported to the Public Health Department in the state where the patient resides.
OREGON:
PROVISIONAL GUIDANCE FOR HEALTH SYSTEMS FOR COVID-19 TESTING
https://govstatus.egov.com/OR-OHA-COVID-19
WASHINGTON:
COVIC-19 TESTING INFORMATION FOR HEALTHCARE PROVIDERS
IDAHO:
2019 NOVEL COVID-19 TESTING IN IDAHO
https://healthandwelfare.idaho.gov/Portals/0/Health/Labs/SL_Blast_2020-02-20_COVID19.pdf
CHECKLIST FOR EVALUATING SUSPECTED PATIENT UNDER INVESTIGATION (PUI)
https://healthandwelfare.idaho.gov/Portals/0/Health/Epi/COVID-19%20assessment%20guidance_DPH.pdf
ALASKA:
INFORMATION FOR ALASKA HEALTHCARE PROVIDERS
http://dhss.alaska.gov/dph/Epi/id/SiteAssets/Pages/HumanCoV/2019-nhcov_AKHCP-info.pdf
ALASKA COVID-19 REPORTING FORM
http://dhss.alaska.gov/dph/Epi/id/SiteAssets/Pages/HumanCoV/COVID_SOEreportform.pdf