CE Mark Convenient 2019-nCoV IgG/IgM Rapid Test Dipstick with the sample of Whole Blood/Serum/Plasma

The COVID-19 IgG/IgM Rapid Test Dipstick 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.

【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.
Remove the test dipstick from the canister. Best results will be obtained within 1 hour after opening the canister.
Place the test card on a clean and level desk, then peel off the strip label of the test card, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen:
To transfer 10 uL of specimen to the specimen area with a dropper or a pipette, then add 1 drop of buffer (approximately 40 uL), and start the timer
For Venipuncture and Fingerstick Whole Blood specimen:
To transfer 20 uL of specimen to the specimen area with a dropper or a pipette, then add 1 drop of buffer (approximately 40 uL), and start the timer.

Wait for the colored line(s) to appear.If the liquid migration is incomplete on the membrane within 3 minutes of sample application, slowly add one drop of buffer to the specimen area.
Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

【INTERPRETATION OF RESULTS】
IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.
IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.
IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region and IgM region.
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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Note:INCP-411B without the Alcohol Pads and the Lancets