KOVIcheck COVID-19 IgG / IgM is an immunochromatographic assay for the detection of SARS-CoV-2-specific human immunoglobulin G and immunoglobulin M in serum/plasma / venous whole blood (fingerstick or venipuncture).
KOVIcheck COVID-19 IgG / IgM detects virus-specific antibodies, which are produced in response to SARS-CoV-2 infection. The person who had an immune response to COVID-19 has specific antibodies that can be diagnosed with the disease regardless of the symptom.
Expected Use
The Rapid COVID-19 IgM / IgG Combo Test Kit is a lateral flow immunoassay intended for qualitative detection and differentiation of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against SARS-CoV-2 into human serum, acid citrate dextrose (ACD) plasma, and fingerstick whole blood. The rapid COVID-19 IgM / IgG Combo Test Kit is designed to help identify people with an adaptive immune system response to SARS-CoV-2, indicating recent or previous infection.
The Rapid COVID-19 IgM / IgG Combo Test Kit should not be used to diagnose or exclude an acute SARS-CoV-2 infection. At this time, it is unknown how Prolonged antibodies persist after infection and if the presence of antibodies confers protective immunity. Serum and plasma testing are limited to laboratories certified under the Clinical Laboratory Improvement Program 1988 Amendments (CLIA), 42 U.S.C 263a, meeting the requirements for moderate or heavy operations complexity tests.
Testing of whole blood samples by fingerstick is limited to laboratories certified by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, who meet the requirements to perform high, Moderate or waived complexity tests. The fingerstick whole blood specimen test is licensed for use in Point of Care (POC), that is, inpatient care settings operating under a CLIA Certificate of Waiver, Certified Compliance, or Certificate of Accreditation.
Results are for the detection of IgM and IgG SARS CoV-2 antibodies. IgM and IgG antibodies against SARS-CoV-2 are generally detectable in the blood several days after the initial infection, although the length of time the antibodies are present after infection is not well characterized. People may have a detectable virus present for several weeks after seroconversion.
Resume
COVID-19 is an acute infectious disease caused by the SARS-CoV-2 virus. The incubation period of the illness varies from 1 to 14 days, during which time infected people can infect other people. Acute SARSCoV-2 infection can also present without symptoms. Respiratory droplets and contact are the main routes of transmission symptoms Initial symptoms in patients include fever, fatigue, and cough, which may develop in dyspnea and other serious manifestations. Some of the severe cases may have acute respiratory distress septic syndrome or shock, or even death.
There are several days of incubation period after infection with the SARS-CoV-2 virus. IgM antibodies can be detected shortly after the incubation period and remain for a short time. IgG antibodies may appear after a few incubation period days and remain circulating in the blood for several weeks. A positive IgG result can be an indicator of a recent or previous infection.
Beginning
Rapid COVID-19 IgM / IgG Combo Test Kit uses the principle of immunochromatography. Anti-human IgM and mouse-human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgM line in the test window is closest to the sample well followed by the IgG line. As the test sample flows through the membrane. Inside the test device, the colloidal gold-recombinant antigen conjugate of the coloured COVID-19 virus is formed complexes with specific antibodies (IgM and/or IgG) against the COVID-19 virus, if present in the sample.
The antigen targets a segment of the SARS-CoV-2 nucleocapsid (N) protein. This complex goes further the membrane to the test region where it is captured by anti-human IgM and/or human IgG antibodies coated on the membrane leading to the formation of a coloured band, indicating positive test results. The absence of this coloured band in the test window indicates a negative test result. A built-in control line always appears in the test window when the test is successful, regardless of the presence or absence of antibodies against the new coronavirus 2019 in the sample.
Supplied Materials
• Rapid COVID-19 IgM / IgG Combo Test Kit
• Individual sample buffer
• 2 μL capillary pipette (serum and plasma only)
• 5 μL capillary pipette (finger stick only)
• Sterile safety lancet
• Insert package
Materials Required But Not Provided
• Clock or stopwatch, sample collection container, biohazard waste container, disposable gloves, disinfectant.
• External controls are not included with the kit but are commercially available from Megna Health under catalogue number: RAK-CON-001.
Storage
1. Store the test device at 4-30 ° C in the original sealed bag. Do not freeze.
2. The expiration date indicated on the bag was established under these storage conditions.
3. The test device should remain in its original sealed bag until ready for use. After opening, the test device should be used immediately. Do not reuse the device.
Warnings And Precautions
• For use only under an Emergency Use Authorization. For in vitro diagnostic use only. This test has not been cleared or approved by the FDA but has been cleared for emergency use by the FDA under a EUA for use by authorized laboratories.
• The fingerstick whole blood specimen test is licensed for use at the point of care (POC), that is, inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate Accreditation.
• This test is licensed only to detect the presence of IgM and IgG antibodies to SARS-CoV2, not to any other virus or pathogen.
• The emergency use of this test is only authorized for the duration of the declaration that the circumstances exist that justify the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564 (b) (1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3 (b) (1) unless the statement is terminated or the authorization is revoked earlier.
• Do not use the product beyond the expiration date.
• Do not use the product if the bag is damaged or the seal is broken.
• Handle all specimens as potentially infectious.
• Follow standard laboratory procedures and biosafety guidelines for handling and disposal of infectious material. When the assay procedure is complete, discard the samples based on the relevant condition and federal requirements for biological samples.
• The tests are for single use only.
Quality Control
- A quality control procedure is included in the test. It will appear as a red line in the control mark area if the test was successful and the reagents are reactive.
- External control standards are not included in the kit. However, external control Standards are commercially available by contacting the manufacturer directly.
- Controls are composed of inactivated negative serum and inactivated positive IgG and IgM serum. Controls are disabled to minimize risks not only from COVID-19 but also from HIV, HBV and HCV
- Controls are available through Megna Health under catalogue number: RAK-CON-001
- Good Laboratory Practice recommends that external positive and negative controls be tested for test kit batch to validate the reliability of the test kits. Users should consult the instructions for use of the external controls. External controls should be run as human specimens following the instructions described in this document. It is recommended to run positive and negative controls each time a new lot is used. It is used, when a new operator performs the test, or when the test is run in a new room/laboratory, etc. as good laboratory practise to confirm the test procedure and verify proper test performance.
- If controls do not provide expected results, repeat the test with a new COVID-19 Rapid Test Card and controls .; If the results are still not correct, please contact Megna Health at support@megnahealth.com.