Coronavirus 2019 Update - Interpath Labs

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CORONAVIRUS – COVID-19 UPDATE

May 19, 2020

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 studies^1,2,3 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).

Cost of COVID Testing

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
Specimen:
Collect:	One SST Also Acceptable Green Top (Li Heparin)
Submit:	1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Also Acceptable 1 mL (Min:0.5 mL) Plasma. Submit Refrigerated. Submit in a Standard Transport Tube.
Rejection Criteria:	Heat inactivated Sample stabalized with azide.
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).

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May 11, 2020

Covid-19 antibody test

coming soon

Watch our website for the date when COVID-19 Antibody testing will be available.

May 7, 2020

Self-collection kits 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.

Self collections can be obtained with provider supervision in providers office

OR

Patients can collect at home and deliver specimen to providers office or Interpath Patient Service Center. If specimen cannot be returned right away, it must be refrigerated

*Collections are not available at Interpath Patient Service Centers

April 29, 2020

Effective April 29, 2020;
Interpath Laboratory is now accepting specimens for testing COVID-19 in our laboratory

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

Please refer to the COVID-19 TEST ORDERING INFORMATION below.

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

COVID-19 TEST ORDERING INFORMATION

April 20, 2020

2785 SARS-CoV-2 by PCR

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).

Who Should Be Tested for COVID-19 ?

CDC recommends an individual for COVID-19 testing if they had/are:

Experiencing a recent fever ≥100° F
Having signs/symptoms of acute respiratory illness (cough, difficulty breathing, upper respiratory complaints).
Had close contact with a person with laboratory-confirmed COVID-19 and/or travel to an area with widespread community transmission within the last 14 days.