vitro diagnostic (ivd) devices coronavirus disease 2019 (covid-19) covid rapid antigen test for travel
Product Description
In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is a rapid chromatographic immunoassay for the qualitative detection of N protein antigens to SARS-CoV-2 present in nasal swab . This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; confifirmatory testing is required.
Date sheet
| Product name: |
Covid -19 Antigen nasal swab rapid test kit |
| Format: |
Card |
| Specimen: |
Swab |
| Sensitivity: |
95.6% |
| Accuracy: |
>99% |
| Specificity: |
98.21% |
| Packing |
25pcs/box; 5pcs/box; 1pcs/box |
| shelf life |
2years |
| Certificate: |
CE , FSC |
Features:
Detects active COVID-19 infection
Detects multiple COVID-19 strains, including the DELTA variant*
Get your COVID-19 test results in just 15 minutes
Easy to follow, illustrated step-by-step instructions
Requires a minimally invasive nasal swab sample
Know your COVID-19 test result now, without the need to wait for results from your healthcare provider
Directions for Use
1. Remove the test device from the sealed foil pouch and use it as soon as possible. Place the test device on a clean and level surface. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Take out 1 Sample Extraction Tube, and remove the sealed film.
3. Place the sterilized swab specimen in the sample extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
4. Remove the sterilized swab while squeezing the sterilized swab head against the inside of Buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilized swab in accordance with your biohazard waste disposal protocol.
5. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the sample extraction buffer. See the illustration below.
6. Add 3 drops of the solution (approx.80ul) to the sample well and then start the timer. Read the result at 10~20 minutes. Don’t interpret the result after 20minutes.
POSITIVE: Two red lines appear. One red line appears in the control region(C), and one red line in the test region(T).The shade of color may vary,but it should be considered positive whenever there is even a faint line.
NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T). The negative result indicates that there are no Novel coronavirus particles in the sample or the number of viral particles is below the detectable range.
INVALID: No red line appears in the control region(C).The test is invalid even if there is a line on test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device.
FAQ
Q: What is your payment terms?
A: Payment terms: 100% TT before shipment
Q: Can you send samples?
A: Yes,SAMPLES can be sent for your evaluation.customer pay the freight charge
Q: Do you give any discount?
A: I'll surely try my best to help you get those by the best price and good service at the same time. We promise the best price upon same quality, and best quality upon same price.
Q: How to order?
A: Please tell us the model and quantity and package requests.
b. Proforma Invoice confirmed, the order will be arranged upon receipt of your payment.
c. Confirm and ship the goods.
d. We will help to track your goods until you receive them safely.
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