KEY FEATURES OF OUR ANTIBODY TESTS

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GENERAL COVID-19 DOCUMENTS

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FREQUENTLY ASKED QUESTIONS

Covid-19 IgM-IgG Rapid Test is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies to SARS-COV-2 virus in human whole blood, serum or plasma.

The test strip uses a colloidal gold recombinant novel coronavirus antigen and a quality control antibody colloidal gold marker. The strip has the follow detection lines:

• IgM - is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody.

• IgG - is fixeda with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody.

• C - The quality control antibody is fixed on the C (Control) line.

Results can be interpreted at 10-15 minutes after sample and buffer are combined in the cassette sample wells.

Due to the Coronavirus Public Health Emergency, the FDA updated its Policy for Diagnostic Tests for COVID-19 on March 16, 2020. Included in this update is guidance for commercial manufacturers, such as our test, for screening tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. On May 4, 2020 and May 11, 2020 it further refined its guidance to read as follows: “Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review.” While an application is under review, please note the following information:

• The test has not been reviewed by the FDA.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

• Negative results do not rule out SARS-CoV-2 infection, especially in those who have been exposed to the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in those individuals.

The results from rapid antibody testing should not be used as the sole basis to diagnose or exclude a COVID-19 infection or to determine an individual’s infection status.

Antibody Test (Healgen): The clinical sensitivity is 93.87% and clinical specificity is 99.10% when compared to RT-PCR. The relative accuracy rate is 97.19%.

Antibody Test (Assure): The clinical sensitivity is 100.00% and clinical specificity is 98.80% when compared to RT-PCR. The relative accuracy rate is 99.10%.

The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use. The advised storage is 2-30⁰C / 36-86⁰F.

• IgM presumptive positive = Indication of onset of acute SARS-CoV-2 infection

• IgG/IgM presumptive positive = Indication of active SARS-CoV-2 infection

• IgG presumptive positive = Indication of later-stage SARS-CoV-2 infection or possible developed immunity.

• Negative = a medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.

The Covid-19 IgM/IgG Antibody Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of this test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.

Antibody Test (Healgen): Professional Health Care institutions only. The Covid-19 IgM/IgG Rapid Test is NOT for home use. Use of this test is limited to laboratories certified to perform high complexity and moderate complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity or moderate-complexity testing.

Antibody Test (Assure): Professional Health Care institutions only. The Covid-19 IgM/IgG Rapid Test is NOT for home use. Use of this test is limited to laboratories certified to perform high complexity and moderate complexity testing, and also authorized for use with fingerstick whole blood specimens at the Point of Care (POC), i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• Urgency – The Covid-19 IgM/IgG Antibody Test can provide presumptive qualitative results onsite in a matter of minutes. Providing healthcare workers with more information at critical moments in the patients care.

• Volume – Low-cost fast turn-around testing of symptomatic patients can reduce the burden on hospitals and clinics. 

• Triage Efficiency – Presumptive antibody results for symptomatic patients allow hospitals to reduce doctor/patient interview time, further diminishing the chance of contagion in a hospital setting. 

• Immunity Screening – Recovering or recovered patients can use the Covid-19 IgM/IgG Antibody Test in conjunction with approved nucleic acid tests to confirm recovery and the existence of virus fighting IgG antibodies in the blood stream.

Yes, both of our antibody tests are reimbursable.

What codes exist?

The American Medical Association (AMA) recently released expedited CPT updates that include two new codes, effective April 10, 2020 for COVID-19 antibody tests:

CPT Code 86769 - falls under parent code 86710 and is specific to antibody tests using a multi-step method using a micro-titer plate, while code 87635 is for detection using nucleic acid methods. 

CPT Code 86328 - falls under parent code 86318 and is specific to antibody tests using a qualitative or semi-quantitative single-step method immunoassay for COVID-19 antibodies. 

For questions about CPT Codes refer to

In response to the COVID-19 pandemic, all providers, laboratories, and facilities performing testing for COVID-19 must report results to local public health authorities. This includes all types of tests, including those offered in point-of-care (POC) settings (e.g., traditional and rapid PCR, rapid antigen, serology).

Depending on one's local public health guidelines, healthcare providers offering POC serology tests should seek guidance locally for specific reporting guidelines and protocol/ instructions. 

Here are some resources available:

CDC Reporting Guidelines: https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html 

Local Health Department Directory: https://www.naccho.org/membership/lhd-directory 

Phone Numbers by state: https://www.cste.org/page/EpiOnCall  

WARNING

This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.

This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This product is intended for professional use and not for home use.

Not for the screening of donated blood.

IMPORTANT NOTIFICATION

The FDA continues to update its guidance in its FAQ section. It is important to check their website daily for latest updates: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.

Do you have any further questions?

Please contact us at sales@plymouthmedical.com or call our customer service hotline at 888-392-5076 Ext.1.

FDA WEBPAGE: 

www.fda.gov/novelcoronavirus 

CDC WEBPAGE: 

www.cdc.gov/COVID19