Healgen Scientific LLC
COVID-19 “CORONAVIRUS” IGG/IGM RAPID TEST KIT
In accordance with FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, we are not selling tests to the general public at this time. Please review our Terms and Conditions at Checkout and confirm you are an eligible purchaser. All orders are being evaluated due to stricter FDA guidelines. If we deem your order is not for professional use then a refund will be given and your order will be cancelled. The FDA has received the necessary intent to launch notices for the COVID-19 IgG/IgM Rapid Test Cassette sold on this website. For additional information regarding the FDA’s Emergency Use Authorization (EUA) for In Vitro Diagnostic Products, please visit this link. This test’s EUA Submission Number is EUA200056.
INSTANT USE KITS
Rapid results in 2-5 minutes
- Small sample sizes
- Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
- Shelf life of 24 months from manufacture date
- Forensic/Professional Use Only
- Tests should be conducted by a licensed phlebotomist, or a medical professional
- Verification of use case prior to shipping is mandatory
Clinical Performance
The COVID-19 lgG/lgM Rapid Test (Whole Blood/Serum/Plasma) has been evaluated with 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms. The results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs etc.) of “Diagnosis and treatment of novel coronavirus pneumonia”.
Regarding the igM test, the result comparison to RT-PCR
Regarding the IgG test, we have counted the positive rate of the 36 of 113 patients during the convalescence period.
Rapid Test Cassette Instructions for Use
- Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
- Place the test device on a clean and level surface.
- (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
- (For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
- Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
Interpretation of Results:
Negative: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.
IgM Positive: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.
IgG Positive: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.
IgG and IgM Positive: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
