Antigen Swab Test Kit of Covid-19 25 Tests/Kit CE Specificity 100%

Limitations

This test is for qualitative detection of SARS-CoV-2 viral antigens only. The test cannot determine the exact concentration of the SARS-CoV-2 viral antigen.

The test results are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in conjunction with their symptoms, signs, medical history, other laboratory tests, response to treatment, and epidemiological information.

Proper specimen collection is critical. Failure to follow procedures may result in inaccurate test results. Improper specimen collection, storage, or even freezing and thawing can lead to inaccurate test results.

False-negative test results may occur if the viral load in the specimen is below the limit of detection or if the specimen was improperly collected or transported; therefore, a negative test result does not exclude the possibility of infection with SARS-CoV-2.

A positive result does not rule out co-infection with other pathogens.

Monoclonal antibodies may not detect SARS-CoV-2 viruses with slightly altered amino acid levels in the target epitope region, or they may be less sensitive to detect them.

As the disease duration increases, the amount of antigen in the sample may decrease. Samples taken after day 5 of illness are more likely to be negative than RTPCR testing.

These tests target nucleocapsid proteins. Performance was not affected by mutations in the spike protein. Nucleocapsid protein mutations are less likely, but may not be ruled out in the future.

Covid 19 Antigen Swab Test Kit 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)

Clinical 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%.

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%.

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

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.