SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold) 10Tests/Kit CE
Results in 15 minutes
1. Intended Use
The Green Spring ® SARS-CoV-2 Antigen Rapid Test is for the rapid
qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in
human nasal or nasopharyngeal swab specimens. The results are used
for the detection of SARS-CoV-2 antigens. The antigen is generally
detectable in upper respiratory tract specimens during the acute
phase of infections. Positive results do not rule out bacterial
infection or co-infection with other viruses. The pathogen detected
may not be the sole cause of the disease. Negative results should
be considered in the context of a patient's recent exposures,
history, and presence of clinical signs and symptoms consistent
with COVID-19. Suspective cases should be confirmed with a
molecular assay. Professional use only.
2. Materials Supplied
- Test cassette with a pack of desiccant
- Swab
- Disposable 0.5ml extraction buffer
- Package insert
3. Clintcal Performance
The clinical performance of the Green Spring ® SARS-CoV-2 antigen
rapid test was determined in prospective,randomized, single-blind
studies. A total of 310 nasopharyngeal specimens from symptomatic
and asymptomatic patients were collected within 5 days of the onset
of initial symptoms. The performance of the kit was compared with
the results of a commercially available molecular test. The test
was found to have a sensitivity of 98% and a specificity of
100.00%. The accuracy is 99.35%.
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% |
For the anterior nasal swab method,263 specimens were collected.A
sensitivity of 96.8% and a specificity of 100.00% were determined
for the test. The accuracy is 98.48%.
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%) |
EU Authorized Representative: Obelis s.a.
Bd General Wahis 53, 1030 Brussels Belgium,
4. Test Principle
The Green Spring ® SARS-CoV-2 Antigen Rapid Test is a qualitative,
membrane-based immunoassay for the detection of nucleocapsid
protein antigens of SARS-CoV-2, The test line region is coated with
a SARS-CoV-2 antibody. The sample reacts with the SARS-CoV-2
antibody in the test line region. If the specimen contains
SARS-CoV-2 antigensa colored line appears in the test line region
(T) as result. As a procedural control, a colored line appears in
the control line area(C) indicating that the correct volume of
sample has been added and membrane wicking has occurred correctly.
5. SARS-CoV-2 Antigen Self Test Kit Instructions
6. SARS-CoV-2 Antigen Self Test Kit CE certificate
7. Storage and Stability
Store the tests in the sealed foil pouch at room temperature or
refrigerated (2 -30 "C). The test is stable until the expiry date.
The test cassettes should be kept in the sealed foil pouch until
use. Do not freeze. Do not use after expiration date. Keep away
from sun, moisture and heat.
Q1: How long will it take for you to ship?
A1: Usually ships within 7 working days.
Q2: Do you support OEM/ODM?
A2: can be supported. We can customize according to your specific
needs and specific quantities.
Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 certification and ISO13485 certification, so
far all the production process, we have standard rules, we comply
with the relevant behavior and laws of the government.
Q4: Is after-sales service guaranteed?
A4: We provide professional online technical after-sales service.
If the product fails during the experiment, we can provide
one-to-one guidance through telephone, video and other forms.
Q5: What is your minimum order quantity?
A5: 1Kit.
Q6: What is the shipping method?
A6: It can be shipped by express (FEDEX, UPS, DHL, EMS, etc.) or by
air and ground.Please confirm with us before placing an order.
