Antigen Home Test Kit of SARS-CoV-2 25 Tests/Kit CE Accuracy 99.68%
Professional
Clinical Performance
The clinical performance of the Green Spring® SARS-CoV-2 Antigen
Rapid Test was determined in a prospective, randomized,
single-blind study. Within 5 days 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 specimens were
collected for testing. The test had 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%) |
Possible uses
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. A negative result 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.
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
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: How long does it take for your delivery?
A1: Usually ships within 7 working days.
Q2: Do you support OEM/ODM?
A2: It 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 behaviors and laws of the government.
Q4: Is the after-sales service guaranteed?
A4: We provide professional online technical after-sales service.
If the product fails during the experiment, we can provide
One-on-one coaching via phone, video, etc.
Q5: What is your minimum order quantity?
A5: 1 kit.
Q6: What is the shipping method?
A6: Can be shipped by express (FEDEX, UPS, DHL, EMS, etc.) or by
air and ground. Please confirm with us before placing an order.
