Antigen Home Test Kit of SARS-CoV-2 25 Tests/Kit CE Accuracy 99.68%
Professional
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%) |
Summary
The novel coronaviruses belong to a β genus. COVID-19 is an acute
respiratory infectious disease. Humans are generally susceptible to
it. Currently, patients infected with novel coronavirus are the
main source of infection; asymptomatic infected people may also be
a source of infection. The main manifestations include fever,
fatigue, and dry cough. A stuffy or runny nose, sore throat, muscle
aches, and diarrhea occur in a few cases.
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 as control line (C)and test line (T)
within the result window indicates a positive result.
Negative: A colored line appears in the control region (C). No visible
colored line appears in the test band region (T).A negative result
does not rule out viral infection with SARS-CoV-2 and should be
confirmed by molecular diagnostic methods if COVID-19 is suspected.
Invalid: The control line does not appear. Insufficient sample volume or
incorrect handling are the most likely reasons for the control line
not appearing. Check the procedure 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.
