NoJVers QR-SJ2J-24/00
SARS-CoV-2 Antigen Rapid Test Kit
CERTIFICATE OF ANALYSIS
Labnovation Technologies, Inc.
NO: f-202201021
ae ‘SARS-CoV-2 Antigen Rapid Test Kit pen re
(mmunochromatography )
20 Tesi | Manufacturing
2 i 20
Sample Quy. Hel var bachne, | 20220121 | Package Size Tests / box
Validation Date | 2022.01.21 | Expiration date | 20230720 Qy. 20 Tests x7750 boxes
Inspection Criteria FactValue | Result_| Memo
Cassette should be flat and free of burrs on the edge.
‘Appearance of Cassette should be neat, uniform in
‘color and no stains.
‘Appearance is complete in an airtight Foil bag. conti SH
1| Appearance | Markings on the package are correct. fa Pass
‘Appearance of packaging should be tidy. ae
Symbols, wordage and logo should be clear.
‘Complete contents and its packaging should not be
damaged.
2| — width | strip width should be not less than 2.50mm. 3.0mm — | 3.0mm
3] speed | Sample migrate speed shoud be not less han ipdincie | her
10mm/min.
‘After diluent was diluted for 1:10, tested with 8
4 positive reference materials (PI ~P8) separately, he | All positive | Pass
results were all positive.
Negative ‘ ‘ :
5 | cone | Tested with 20 negative reference materials (NI ~ | pi nggyiye | Pas
Tete | N20 separately the results were all negative
Using diluent to dilute minimum detection limit
Minimum | reference materials $ for 1:50, 1:100, 1:200, 1:400,
6| Detection | 1:800 and 1:1600, then marked $1~S6. Tested with Positive Pass
Limit | the above 6 concentrations separately, S1~S4 the test
result were positive, S5~$6 no requirement.
Using diluent to dilute repeatable reference product
R for 1:10, 1:100, then marked Rand R2. The test | All positive and
7| Repeatability | was repeated 10 times of above 2 concentrations | the coloration | Pass
and the corresponding reaction results | were uniform.
the coloration was uniform.
Remark:
x
Labnovation Technologles- te. records its own analytical methodology and of quality.
Inspector: Wang Fang
Wes Foy
Approved: Yi Qiuxiang
we Ayacany