COVID-19 IgM + IgG Rapid Test Kit (Colloidal Gold) is based on a one-step lateral flow chromatographic immunoassay. The test strip in the device includes: (1) a conjugate pad containing colloidal gold conjugated COVID-19 antigen and rabbit IgG antibody, and (2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line was precoated with Anti-Human COVID-19 IgM + IgG Antibodies; when an adequate amount of specimen is applied to the sample pad of the device, COVID-19 antibodies in the specimen bind to sites on the colloidal gold conjugated COVID-19 antigen and form a novel “colloidal gold conjugated coronavirus antigen – coronavirus antibody – anti-human COVID-19 IgM + IgG” complex in the nitro cellulose membrane detection line and migrates along the membrane strip. If the specimen contains COVID-19 antibodies, the complex will bind to the capture antibody coated on the T line to develop a burgundy-colored band. If the specimen does not contain COVID-19 antibodies, the T line will not develop. The C line is coated with goat anti-rabbit IgG antibody, which binds to the gold-antibody conjugate and forms a burgundy colored line with or without the presence of COVID-19 antibodies.
Store the kit at room temperature (15-30°C).
Positive for Coronavirus: Both the test line (T) and the quality control line (C) are burgundy colored.
Negative for Coronavirus: The test line (T) does not develop color, or a faint gray band may be visible, but the quality control line (C) is colored.
Suspect: A light band is an inconclusive result. The sample requires an alternate testing method (such as RT-qPCR) to determine positivity.
Invalid: There is no colored control line (C) band. The results are invalid regardless of whether a burgundy band appears on the test line (T) – additional testing is required.
Independent Evaluation by Authorities and Third Parties
COVID-19 Testing Project, USA
A total of 10 commercially available serological tests are evaluated by a group of researchers and physicians at UCSF, UC Berkeley, Chan Zuckerberg Biohub and Innovative Genomics Institute.
The VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) has ONLY been designed to act as a supplementary test for suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. Results from IgM/IgG antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) IS INTENDED FOR USE BY HEALTHCARE PROFESSIONALS AND CLINICAL LABS ONLY. DO NOT SEPARATE TEST COMPONENTS. IMPROPER USE MAY PRODUCE INVALID AND/OR UNRELIABLE TEST RESULTS.
DO NOT USE IF PACKAGE SEAL HAS BEEN REMOVED OR BROKEN.
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 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: Hold the 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.