Professional Virus Test REAGEN COVID-19 Real-Time Fluorescence PCR Detection Kit

SPECIMEN COLLECTION AND PREPARATION

The test can be performed with whole blood, serum and plasma. For whole blood:
1. Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube with suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium). Other anticoagulants have not been validated and may give
incorrect result.

2. It is recommended that whole blood specimen is tested at the time of specimen collection. If the specimens are not tested
immediately, they may be stored at 2ºC～8ºC for up to 7 days. Prior to testing, mix the blood by gentle inversion several times, do
not freeze or heat whole blood specimens.

For Serum and Plasma:
1. Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube. If collecting
plasma use a blood collection tube containing suitable anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give incorrect result.
2. Centrifuge whole blood and separate the plasma from red blood cell as soon as possible to avoid hemolysis.
3. Test should be performed within 8 houres after the specimens have been collected. Do not leave the specimens at room temperature
for prolonged periods. Serum or plasma specimens may be stored at 2ºC～8ºC for up to 3 days prior to testing. Serum or plasma
specimens may be stored at -20ºC for up to 9 days.

Note: Bring specimens to room temperature before testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should
not be frozen and thawed repeatedly. Severe hemolytic or heat-inactivated specimens are not recommended.

TEST PROCEDURE

Please read the instruction for use carefully before performing the test.
1. Allow the device, buffer and specimen to equilibrate to room temperature (10ºC ～30ºC) prior to testing.
2. Remove a test cassette from the foil pouch by tearing at the notch and place it on a level surface.
3. Transfer 10 μL of whole blood or serum or plasma specimen to the sample well (small well) and then add 2-3 drops (80 μL) of buffer
solution to the buffer well (large well).
4. As the test begins to work, you will see purple color move across the result window in the center of the test device.
5. Wait for 15 minutes and read the results. Do not read results after 20 minutes.

RESULT INTERPRETATION

Positive Result
Colored bands appear at both test line (T) and control line (C). It indicates a positive result for the SARS-CoV-2 antibodies in the specimen.
Negative Result Colored band appear at control line (C) only. It indicates that the concentration of the SARS-CoV-2 antibodies is zero or below the

detection limit of the test.

Invalid Result
No visible colored band appear at control line after performing the test. The directions may not have been followed correctly or the test
may have deteriorated. It is recommended that the specimen be re-tested