Rapid Ag Antigen Self Test Kit SARS-CoV-2 For Nasal Throat Buccal 25 Tests/Kit

SARS-CoV-2 Ag Rapid Professional Test Kit for Nasal Throat Buccal 25 Tests/Kit

Limit of Detection (analytical sensitivity)

The limit of detection (LOD) for the Green Spring ® SARS-CoV-2 Antigen Rapid Test is 4 x 10² TCID₅₀/mL.The LOD for Green Spring ® SARS-CoV-2 Antigen Rapid Test Kit was determined using limiting dilution of a gamma irradiation inactivated virus sample. The sample was provided at a concentration of 1.3 x 10⁶ TCID₅₀/mL.

HIGH-DOSE HOOK-EFFECT

The LOD study tested the highest concentration of the sample (TCID₅₀ of 1.3 x 10⁶ TCID₅₀/mL). No Hook-effect was detected.

EU Authorized Representative: Obelis s.a.

Test principle

The Green Spring® SARS-CoV-2 Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of the nucleocapsid protein antigen of SARS-CoV-2 with the detection line area coated with SARS-CoV-2 antibodies. The sample reacts with SARS-CoV-2 antibodies in the test line area. If the sample contains SARS-CoV-2 antigen, a colored line will appear in the test line area T. As a program control, a colored line appears in the control line area C, indicating that the correct volume of sample has been added and that membrane wicking has occurred correctly.

Package and Specification

25 tests/kit (1 test/bag x 25 bags)

Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.

Component

Using Direction

Warnings and Precautions

1. The package insert must be read carefully before testing.
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 before and during the test.
4. Do not use if the package or test element is damaged.

5. Appropriate laboratory safety techniques should always be followed when handling SARS-CoV-2 patient samples. The test strips used for patient swabs and the extraction buffer bottles used can be potentially infectious. Laboratories should develop appropriate handling and disposal methods in accordance with local regulatory requirements.
6. Wear protective clothing such as a lab coat, disposable gloves, and goggles while testing, and wash hands thoroughly after testing.
7. Samples stored in virus transfer media (VTM) may affect test results.

8. Humidity and temperature may adversely affect results.

Prepare

Use only the materials provided with the kit. Test samples immediately.
Allow the kit to equilibrate to room temperature (15 to 30 °C). This test kit is only suitable for swab samples collected and tested directly (i.e. swabs not placed in shipping media).
This kit is not suitable for testing liquid samples such as wash or aspirate samples or swabs in shipping media.
1. Tear off the foil bag, remove the test box and place it on a clean, flat surface.
2. Freshly collected samples should be processed within 1 hour.

3. Mark the appropriate test cartridge and extraction tube for each test.
4. Place the extraction tube in the cardboard tube holder. Pour the entire contents of the extraction buffer (or a 10-drop spare pack from the extraction buffer bottle) into the extraction tube.

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.