TECH
ACTION
COVID-19 Antibody Test
Detection of SARS-CoV-9 antibodies in whole blood, plasma or serum for suspected COVID-19 patients for healthcare providers.
Test Principle
1. The Rapid COVID-19 IgM/IgG Antibody Screen Test is a qualitative
membrane strip-based immunoassay for the detection of COVID-19
IgM/IgG antibody in serum, plasma or whole blood.
2. Anti-human IgM or anti-human IgG antibody is immobilized in the test line region of the test. After a serum, plasma, or whole blood specimen is added in the specimen well, it reacts with COVID-19 antigen coated particles that have been applied to the specimen pad.
3. Gold-labeled Nucleoprotein viral protein is precoated just distal to the sample well.
4. If the specimen contains COVID-19 IgM/IgG antibodies, a colored band will appear in the test line region indicating a positive result.
5. If the specimen does not contain COVID-19 IgM or IgG antibodies, no colored band would appear in this region indicating a negative result.
6. To serve as a procedural control, a colored band will appear at the control line region as indication that a sufficient volume of specimen has been added and membrane wicking has occurred
Intended Use
1. Screen symptomatic and asymptomatic patients for serologic evidence of current or past exposure to SARS-CoV2.
2. Perform contact tracing to identify individuals who have been exposed or at risk of infection with SARS-CoV-2.
3. Monitor serologic status of individuals who may receive future vaccines developed to prevent infection with SARS-Cov-2.
4.The Rapid COVID-19 IgM/IgG Antibody Screen Test is a rapid visual qualitative detection of COVID-19 IgM/IgG antibodies in fingerstick whole blood, sera and plasma as an aid in the diagnosis of SARS-CoV-2 infection.
5. This Test is for use only in laboratories or by healthcare workers at the point-of-care and is NOT for home use.
6. The tests are available in Cassette format.
7. All results should be confirmed with molecular diagnostics to confirm any results.
8. For research use ONLY
9. FOR EXPORT ONLY
Positive Results
Detection of IgG antibodies with specificity for the S1 protein identifies individuals recently exposed to the SARS-CoV-2 virus, possibly 14 days to 3 months previously. They may be currently asymptomatic and potentially inmune to re-infection. Community surveillance and contact tracing is required to interrupt further transmission of COVID-19 infection.
*We cannot support the diagnostic guidelines. At this time it is unknown for how long the IgM and IgG antibodies detected may persist and whether or not they provide immunity.
The test itself does not diagnose or exclude infection status of COVID-19 as it tests for the presence of antibody
