Ag Rapid Test Kit of Covid 19 25 Tests/Kit Specificity 100%
Professional
Intended use
The Green Spring ® SARS-CoV-2 Antigen Rapid Test is used for the
rapid qualitative detection of SARS-CoV-2 nucleocapsid protein
antigens in human nasal or nasopharyngeal swab samples. The results
were used to detect SARS-CoV-2 antigens. This antigen is usually
detectable in upper respiratory tract specimens during the acute
phase of infection. A positive result does not rule out bacterial
infection or co-infection with other viruses. The detected pathogen
may not be the only cause of the disease. Negative results should
be considered in conjunction with the patient's recent exposure,
medical history, and the presence of clinical signs and symptoms
consistent with COVID-19. Suspected cases should be confirmed by
molecular testing. Professional use only.
Clinical Performance
The clinical presentation of the rapid SARS-CoV-2 antigen test was
determined in a prospective, randomized, single-blind study. Within
5 days of the onset of suspected symptoms, 310 nasopharyngeal
specimens were collected from symptomatic and asymptomatic
patients. The performance of this kit was compared to the results
of commercially available molecular tests. The test was found to
have 98% sensitivity and 100.00% specificity. The accuracy is
99.35%.
For the anterior nasal swab method, a total of 263 samples were
collected for testing. The test has a sensitivity of 96.8% and a
specificity of 100.00%. The accuracy is 98.48%.
| Greenspring SARS-COV2-Antigen-rapidtest (nasopharyngeal) | PCR-Comparator | Total |
| Positive | Negative | |
| Positive | 98 | 0 | 98 |
| Negative | 2 | 210 | 212 |
| Total | 100 | 210 | 310 |
| Sensitivity | 98% (95% Cl: 97,12-99,98%) |
| Specificity | 100% (95% Cl: 98,12-99,99%) |
| Accuracy | 99,35% |
Greenspring SARS- COV2-Antigen-rapidtest (anterior nasal)
| PCR-Comparator | Total |
| Positive | Negative | |
| Positive | 121 | 0 | 121 |
| Negative | 4 | 138 | 142 |
| Total | 125 | 138 | 263 |
| Sensitivity | 96,8% (95% Cl: 91,52-98,97%) |
| Specificity | 100% (95% Cl: 96,62-100%) |
| Accuracy | 98,48% (95% Cl: 96,17-100%) |
Warnings and precautions
1. The package insert must be read carefully before performing the
test.Failure to follow the instructions in the package insert may result
in inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after
expiration date.
3. Do not drink or smoke 10 minutes prior and during testing.
4. Do not use the test if the packaging or test components are
damaged.
5. Proper laboratory safety techniques should be followed at all
times when working with SARS-CoV-2 patient samples.Patient swabs
used Test Strips and used extraction buffer vials may be
potentially infectious. Proper handling and disposal methods should
be established by the laboratory in accordance with local
requlatory requirements.
6. Wear protective clothing such as lab coats, disposable gloves
and eye
protection while testing and wash hands thoroughly after performing
the test.
7. Samples stored in Viral Transport Media (VTM) may affect test
results.
8. Humidity and temperature may adversely affect results.
Package and Specification
25 tests/kit (1 test/bag x 25 bags)
Product Advantages
1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 15 minutes
5. Cost-efficient
Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is
99.68%.
Component
| test/bag | 25 bags |
| 0.5mL extraction buffer | 25 bottles |
| Sterile single-use sampling swab | 25 pieces |
| Package insert | 1 piece |
Using Direction
Interpretation of the test result
Positive: The presence of two lines in the results window as control line C
and test line T indicates a positive result.
Negative: Colored lines appear in control area C. No visible colored lines
appear in the test strip area T. A negative result does not rule
out viral infection with SARS-CoV-2, and in the case of COVID-19,
the suspicion should be confirmed by molecular diagnostic methods.
Invalid: Control lines do not appear. Insufficient sample volume or
improper handling is the most likely reason for the control line
not appearing. Check the program and repeat the test with a new
test cassette.
Storage and Stability
1. Store in a sealed bag at 2~30℃ until the shelf life, and the
validity period is tentatively set for 12 months. Do not freeze.
2. After the test cassette is taken out of the aluminum foil bag,
it should be used within 1 hour.
3. Keep away from sunlight, humidity and heat sources.
Q1: When will it be shipped?
A1: We will ship the goods for you as soon as possible within 7
working days after receiving the payment. (In the event of the
epidemic and other external factors, there may be delays in
shipping)
Q2: Does it support OEM/ODM?
A2: It can be supported, but the specific quantity needs to be more
than 100,000 pieces to facilitate customized products.
Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 and ISO13485 certified by the state. Our
production process is in accordance with the standard process,
which can ensure that the quality of the products is optimal.
Q4: How is after-sales service provided?
A4: We provide professional online technical after-sales service.
We can provide you with one-on-one guidance in the form of video,
phone calls, etc.
Q5: What is the payment method?
A5: We receive payment by T/T.
Q6: How to ship?
A6: By obtaining quotations from our many cooperative carriers,
choose the best way to ship for you, or you can ship according to
your requirements.
