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Severna Laboratories is proud to release a COVID-19 IgM/IgG Antibody Rapid Test. Made In USA.
COVID-19 Tests for professional use now available
The Severna Laboratories COVID-19 IgM/IgG Rapid Test is a lateral flow immunoassay test device for the rapid presumptive qualitative simultaneous detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma.
Our test
Easy, Efficient & Accurate Screening Device for COVID-19
• COVID-19 Positive/Negative Results in 15 Minutes
• Works with Fingerstick, Whole Blood, Serum or Plasma
• Increased Screening with IgM and IgG Antibody Detection
• Ideal High-Volume Screening Device to Complement Nucleic Acid Tests
COLLOIDAL GOLD RAPID TEST VS. NUCLEIC ACID (PCR) TEST:
FLUORESCENCE-PCR
Test Time: 3-4 hours
Operational Method: Complex with supporting equipment required
Portability: Requires highly complex equipment only available in large hospitals
COLLOIDAL GOLD
Test Time 15 Minutes
Operation Method: Simple without supporting equipment required
Portability: Highly portable and stable test device at room temperature. Testing can be conducted at Point of Care including certified small labs, clinics or patient bedside.
Frequently Asked Questions
1. What is the COVID-19 IgM-IgG Antibody Test?
A: Severna Laboratories 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.
2. How quickly can the COVID-19 IgM/IgG Antibody Test yield results?
A: Results can be interpreted at 10~15 minutes after sample and buffer are combined in the cassette sample well.
3. Is the COVID-19 Antibody IgM/IgG Antibody Test available for sale in the United States?
A: 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 Severna Laboratories, for screening tests that identify antibodies (e.g., IgM, IgG) to sARS-CoV-2 from clinical specimens. This updated policy allows for testing by healthcare workers at the point of care or in laboratories. At-home testing is not covered by this guidance. In March 2020 W.H.P.M. submitted an Emergency Use Authorization (EUA) to the FDA. While this application is under review, please note the following information:
- Severna Labs’s COVID-19 IgM/IgG Antibody 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.
4. How does the COVID-19 Antibody Test work?
A: 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 fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody.
- C- The quality control antibody is fixed on the C (Control) line.
5. How accurate is COVID-19 IgG/IgM Antibody Test Device?
A:The clinical sensitivity is 93.5% and clinical specificity is 100% when compared to RT-PCR. The relative accuracy rate is 97.9%.
6. Can the device be frozen for long-term storage?
A: 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.
7. What is the significance of the various test results??
- 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.
8. What is the alternative to using this rapid test?
A: 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.
9. Who can buy and use the Covid-19 IgM/IgG Antibody Test?
A: Professional Health Care institutions only. The Covid-19 IgM/IgG Antibody Test is NOT for home use. The test must be conducted, and the results interpreted by a trained medical professional.
10. What are the benefits of using this type of Rapid Test?
A:
- 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.
IMPORTANT NOTIFICATION:
According to Section D in the FDA Guidance document entitled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”, issued on web 3-16-2020, please note the following requirements (actual verbiage from guidance document):
Commercial Manufacturer Development and Distribution and Laboratory Development and Use of Serology Tests Without an EUA The policy described in this subsection applies to developers of serology tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. This policy is limited to such testing in laboratories or by healthcare workers at the point-of-care. This policy does not apply to at home testing.
Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports: ·
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- 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.
FDA recommends that developers planning to submit an EUA for serological testing as the sole basis to diagnose or inform infection status, include information along the lines of the statements above in their test reports until data is submitted and an EUA is authorized for additional uses.
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.
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