• Each individual foil envelope contains: 1 x Test cassette
1 x Dropper
1 x Desiccant pouch
• Buffer solution
• Instructions for use
One Step COVID-19 Test is used for detecting COVID-19 antibodies in human whole blood, serum or plasma sample, and is suitable for the preliminary screening test for the patients with suspected COVID-19 infection.
For in vitro diagnostic use only.
One Step COVID-19 Test uses with immunochromatography assay for the detection of COVID-19 antibodies in human whole blood, serum and plasma. When the COVID-19 antigen level in the specimen is at or above the target cutoff (the detection limit of the test), the antigen bound to the antibody-dye conjugate are captured by anti-COVID-19 antibody immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the COVID-19 antigen level in the specimen is zero or below the target cut off, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result.
To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly
1. This kit is for in vitro diagnostic use Do not swallow.
2. All specimens should be treated as capable of transmitting
3. Icteric, lipemic, hemolysed, heat treated and contaminated blood may cause erroneous
4. Discard after first use. The test cannot be used more than
5. Do not use test kit beyond the expiration
6. Do not use the kit if the pouch is punctured or not well sealed.
7. Keep out of the reach of
8. DISPOSAL OF THE DIAGNOSTIC: The used-device has the infectious risk. The process of disposing the diagnostic must follow the local infectious disposal law or laboratory regulation
【STORAGE AND STABILITY】
1. Store at 4-30 ℃ in the sealed pouch up to the expiration date printed on the package. The shelf life is 24 months.
2. The test cassette should be used within 1 hour after taking out from the foil envelope. Buffer solution should be re-capped in time after
3. Keep away from sunlight, moisture and
【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 (EDTA, Heparin, Citrated sodium).
2. It is recommended that specimens should be tested Do not leave the specimens at room temperature for prolonged periods. If the specimens are not tested immediately, they may be stored at 2°C～8°C.
3. It’s not suitable to test the whole blood samples which have been stored at 2°C～8°C for more than 7
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 (EDTA, Heparin, Citrated sodium).
2. Separate the serum/plasma from blood as soon as possible to avoid
3. Test should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2°C～8°C for up to 3 For long-term storage, specimens should be kept below -20°C.
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. Only clear, non-hemolyzed specimens can be used.
Allow the device, buffer and specimen to equilibrate to room temperature (10°C ～30°C) prior to testing.
1. Remove a test cassette from the foil pouch by tearing at the notch and place it on a level
2. Slowly add 10 μL of whole blood or serum or plasma to the sample well (A) and then add 2～3 drops (80 μL) of buffer solution to the buffer well (B).
3. As the test begins to work, you will see purple color move across the result window in the center of the test device.
4. Wait for 15 minutes and read the results. Do not read results after 20
Positive: colored bands appear at both test line (T) and control line (C).
Negative: colored band appear at control line (C) only.
Invalid: 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.
Positive coincidence rate: Test 3 positive COVID-19 samples (P1～P3) with One Step COVID-19 Test, all of them showed positive results.
Negative coincidence rate: Test 5 negative COVID-19 samples (N1～N5) with One Step COVID-19 Test, all of them showed negative results.
Repeatability: Test 1 positive COVID-19 sample with One Step COVID-19 Test for 10 times, all of them showed positive results.