COVID-19 IgG and IgM Rapid Test Device

COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma. COVID-19 IgG/IgM Rapid Test Device is for professional use only.

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Description

Intended Use

Materials:

● Individually packed test devices

● Disposable pipettes

● Sterile safety lancet (if required)

● Buffer

● Package insert

● Alcohol Prep pad (if required)

Features:

Sample: Whole blood, Serum or Plasma

Sample Volume: 5µL

Testing Time: 15 minutes

Shelf life: 24 months

Storage Condition: 4°C-30°C

Application:

● Early screening of suspected cases in primary hospitals and fever clinics.

● Early screening in schools and public places.

● Early screening of the employees of enterprises and institutions before returning to work.

● On-site screening of the community.

Test procedure:

Specimen Collection:

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface. Label the test with patient or control identification.

Note: There should be a blue line in the control region (next to “C”), discard the device if there is no blue line.

3. Twist off the cap of the buffer ampule.

4. Add the specimens

For Serum or Plasma Specimens

a) Using the provided disposable pipette, draw the specimen up to the Fill Line, and transfer all the specimen (appr. 5 µL) into the specimen well of the test device, then add 3 drops of buffer and start the timer.

For Venous Whole Blood Specimens

a) Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of disposable pipette) and transfer one drop of the specimen into the specimen well of the test device, then add 3 drops of buffer and start the timer.

For Fingerstick Blood

a) Clean the puncture site with the alcohol prep pad provided

b) Carefully remove the cap from the safety lancet. Push the safety lancet firmly against the puncture site until it pricks the finger.

c) Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of disposable pipette) and transfer one drop of the specimen into the specimen well of the test device, then add 3 drops of buffer and start the timer.

5. Wait for the blue line change to red line. Read results at 15 minutes.