COVID-19 Antibody Rapid Detection Kit
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent
and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
Instructions for Use:
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):
a. For Serum or Plasma Specimen: With the 5 μL plastic dropper provided, draw serum/plasma specimen to
exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/
plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer
well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
b. For Whole Blood Specimen (Venous): Hold the 5 μL plastic dropper vertically and transfer 1 drop of whole
blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample
buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved
across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to
the buffer well (B).
4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
*Detection Window (IgM): 3-5 days after incubation
*Dual band results for simple interpretation
*Multivariable analysis of immunoglobin IgG & IgM
*Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
*Procedural internal control included
* Sensitivity: IgG 97.2%; IgM 87.9%
* Specificity: IgG 100%; IgM 100%
* Specimen: Whole Blood, Serum, Plasma
* Time to Results: 10 minutes
* Shelf Life: 24 months from the date of manufacture
How accurate is COVID-19 IgG/IgM Rapid Test Device?
The COVID-19 IgG/IgM has been evaluated with the 113 blood samples obtained from patients exhibiting
pneumonia or respiratory symptoms.
The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.
The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room
temperature before use.
What is the significance of the various test results?
IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe
symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
IgM positive, IgG positive/negative: Acute or recent infection.
IgM negative, IgG positive: Previous, distant infection.
This test has been validated but independent review by the FDA is not yet complete.
This product is intended for professional use and not for home use. Results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
A negative result may appear and not correlate with symptoms. A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result.