Active Member
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[China]
Address: Huafa Mansion, Binhu District, Wuxi, Jiangsu Province, China
Contact name:Soohia
Wuxi Owgels Medical Instruments Co., Ltd |
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Covid-19 Antigen Rapid Test Kit Pharyngeal test one step test
This kit is a solid phase immunochromatographic sandwich assay that
is intended for the rapid, qualitative and differential detection
nucleocapsid protein antigen from SARS-CoV-2 in human oral saliva
specimens.
Testing is only limited to professional laboratories.
The COVID-19 Antigen Rapid Test Kit is a lateral flow
immunochromatographic assay. The test uses COVID-19 antibody (test
line T) and goat anti-mouse IgG (control line C) immobilized on a
nitrocellulose strip.
The burgundy colored conjugate pad contains colloidal gold
conjugated to anti-COVID-19 antibody conjugated with colloid gold
(COVID-19 conjugates) and mouse IgG-gold conjugates.
Clinical Performance of Antigen Test Kit
A total of 67 positive samples and 100 negative samples were
detected to evaluate the clinical performance of the COVID-19
Antigen Rapid Test Kit.
The Result is below:
| Sansure Covid-19 RT-PCR Assay | ||||
| Positive | Negative | Total | ||
| COVID-19 Antigen Rapid Assay | Positive | 64 | 0 | 64 |
| Negative | 3 | 160 | 163 | |
| Total | 67 | 160 | 227 | |
The assay demonstrated acceptable total clinical sensitivity is
95.52% (95% CI: 87.64%- 98.47%) when compared to a molecular device
produced by Sansure Inc. The assay demonstrated excellent clinical
specificity 100% (95% CI: 97.66%-100%). Overall
Agreement was 98.68% (96.19%-99.55%).
| SPECIMEN COLLECTION AND HANDLING | |
| 1. | Gargle with clean water before sampling |
| 2. | Unscrew the lid of the Extraction Tube, insert the saliva specimen collection funnel and screw it tightly. |
| 3. | Cough up secretions deep in the throat, accumulated in the oral cavity. |
| 4. | Use a saliva specimen collection funnel to collect fresh secretions in the oral cavity, reach the oral secretion scale mark. |
| 5. | Unscrew the funnel to allow the secretions to slip into the extraction buffer, tighten the funnel immediately and shake the collection tube. |
| 6. | Rotate to remove the funnel, place the white tip into the collection tube. |
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after
expiration date.
2. This package insert must be read completely before performing
the test. Failure to follow the insert gives inaccurate test
results.
3. Do not use it if the pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any
circumstances.
5. Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout testing and follow the standard procedures for proper
disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie.
electric fan or strong air- conditioning.
9. Test is only for oral saliva specimens If test other specimens
such as nasal, throat or nasopharyngeal swab specimens or
serumplasmaurine specimens, the results are only for research.
10. Sample collection and handling procedures require specific
training and guidance.
11. Do not pour sample from the Extraction Tube into the Test
Cassette sample well. Use the provided dispensing tip of Extraction
Tubes when adding the sample to the Test Cassette.
