SARS-CoV-2 Antigen Self Test Kit 10 Tests/Kit CE for Nasal Specificity 99.99%

Materials Provided

Cross Reactivity and Microbial Interference

The cross-reactivity with the following microorganisms was examined. Samples that tested positive for the following microorganisms were negative when tested with the SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). The microbial interference study evaluated whether microorganisms possibly contained in clinical samples interfere with the detection capability of the kit which may lead to false negative results. Each microorganism was tested in the presence of a fabricated SARS-CoV-2 positive sample. No cross-reactivity or interference with the microorganisms listed in the table below was found.

Antigen Self Test Kit Test Procedure

1. Blow your nose. Wash or disinfect your hands. Remove the test cassette by tearing open the foil pouch and place it in front of you.
2. Tear off the seal of extraction buffer tube, Press in the perforated hole on the top of the packaging and use the hole as a tube stand.
3. Remove the swab. Do not touch the sterile tip of the swab. Instead, grasp the swab by the handle. Insert the swab about 2.5 cm deep into your nostril until you feel resistance.

4. Collect sample from left and right nostrils with the same swab: Rub the swab against the inner wall of the nose and turn it at least 5 times to ensure sufficient sample is collected. Repeat the process in the other nostril.
Note: Children under 15 years of age (at least 2 years old), and people including the elderly and sick who are unable to perform the test themselves should be tested by another adult. To sample a child, insert a cotton swab into one of their nostrils until you feel some resistance (about 2 cm). Rotate the swab against the nasal wall 5 times. Repeat the sampling process by removing the swab and inserting the same swab into the other nostril. If the child feels any pain, do not continue the test.
5. Dip a cotton swab into the tube and make sure it is well mixed with the extract by stirring and dipping up and down at least 5 times. Let the cotton swab soak for a minute.
6. Slowly pull the swab out of the tube while gently squeezing the sides of the tube to retain as much liquid in the tube as possible.

7. Place the dropper tip firmly on the extraction buffer tube and mix the liquid thoroughly.
8. Drop 3 drops into the sample well (S) on the test card.
9. Interpret the test result between 15-20 minutes. The result after 20 minutes is invalid.

Interpretation Of The Test Result

Check whether a line is visible at the control line (C). The color thickness of the control line (C) is irrelevant. If it is not visible, the test was not performed correctly and a new test with a new test set must be performed.

Storage and disposal

Store at room temperature (2-30°C or 35.6-86 T).
Shelf life 12 months (from production date to expiration date).
Test cassettes must be stored in airtight foil pouches until use. Do not use after expiration date.
Waste from used tests should be disposed of according to local regulations.

Clinical early warning indicators for severe and critically ill patients with COVID-19

Aldult:

Progressive exacerbation of hypoxemia or respiratory distress;

Deterioration of tissue oxygenation indices or progressive elevation of lactate;

Progressive decrease in peripheral blood lymphocyte count or progressive increase in peripheral blood inflammatory markers such as IL-6, CRP, and ferritin;

·D-dimer and other coagulation function-related indicators were significantly increased;

·Chest imaging showed significant progression of pulmonary lesions.

Child:

increased breathing rate;

· Poor mental response, lethargy;

a progressive increase in lactic acid;

Inflammatory markers such as CRP, PCT, and ferritin were significantly increased;

Imaging showing bilateral or multilobar infiltration, pleural effusion, or rapid progression of the disease in a short period of time;

· Neonates with underlying diseases (congenital heart disease, bronchopulmonary dysplasia, respiratory malformation, abnormal hemoglobin, severe malnutrition, etc.), immunodeficiency or low (long-term use of immunosuppressants).

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.