CE COVID-19 IgG/IgM Rapid Test Cassette

The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 in human whole blood, serum or plasma specimen, and also in Fingerstick Whole Blood specimen.

【SUMMARY】

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.¹ Six coronavirus species are known to cause human disease.² Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.²

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
To use a dropper: Hold the dropper vertically, draw the specimen to the fill line
(approximately 10 μL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
To use a pipette: To transfer 10 uL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
For Venipuncture Whole Blood specimen:
To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx.20 μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 μL) and start the timer.
To use a pipette: To transfer 20 uL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
For Fingerstick Whole Blood specimen:
To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx.20 μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 μL) and start the timer.
To use a capillary tube: Fill the capillary tube and transfer approximately 20 μL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.

3. Do not interpret test results visually.
For Reader installation, start up and complete instructions refer to the Reader User Manual. Operator must consult the Reader User Manual prior to use and become familiar with the processes and quality control procedures.

Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

【INTERPRETATION OF RESULTS】

Results read by the LF Reader
The result of positive or negative for SARS-CoV-2 is determined by the LF reader. Result could be exported to excel or PDF. Other clinically available tests are required if questionable results are obtained.