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Rapid Diagnostic Home COVID-19 Antigen Test Kit

  • Cofoe
  • Antigen Test Kit
  • 2,000
  • $0.679
Availability:


Introduction


SARS-CoV-2 Antigen Test Kit is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 in anterior nasal swab specimen from individuals suspected of being infected with COVID-19. This self-test Kit is intended to be used in the home or similar environment by a lay person. For self-testing use and in vitro diagnostic.


Test Principle


This product adopts colloidal gold immunochromatography technology for detecting the SARS-CoV-2 antigen nucleocapsid protein. When the sample contains the coronavirus antigen, both the test line (C) and the control line (T) will appear, and the result will be positive. When the sample does not contain the coronavirus antigen or no coronavirus antigen is detected, the test line (T) will not appear, only control line (C) will appear. If the C line does not appear, it indicates that the test result is invalid, and this sample needs to be tested again.


Main Components


1. Test Device

2. Sample processing tube

3. Nasal swab

4. Self-sealing bag

5. Instruction

6. Timer (Materials required but not provided)


Specification


Principle

Colloidal gold immunochromatography

Sensitivity

90.099%

Specificity

99.010%

Accuracy

97.228%

Specimen

Nasal Swab

Certificate

CE1434

Reading Time

15 minutes

Pack

IT,5T,10T,20T/25T,30T,40T

Storage Temperature

2-30°C

Shelf Life

12 Months


Test Procedure


1. Preparation: Please read the instructions carefully before using this product, check the expiration date and balance the kit to room temperature. Wash and dry your hands.



2. Sample processing:

a) Take out the sample processing tube and unscrew the lower cover. Don’t pour out the liquid. Put the lower cover aside for later use.

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b) Open the package of nasal swab and take out the swab but do NOT touch the head of the swab. Then carefully insert the head of swab into the nasal cavity about 2.5 cm deep in nostrils. Rotate the swab 5 times brushing against the inside of the nostril and take out the swab. Then repeat the process in the other nostril with the same swab.

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c) Insert the completed swab into the liquid of the sample processing tube and rotate it 10 times against the inner wall. Leave the swab inserted, then break the front end of the swab and discard the rest. Cover the lower lid of the sample processing tube.

3

3. Test:

Open the upper cover of the sample processing tube, and drop 85 μL (about 3 drops) of the processed sample into the sample adding hole of the test card.

4

4.Test Results

Read the results of the observation area after 15 minutes. The result read after 30 minutes is invalid

5

Performance


There were 505 cases overall in the study, including 101 positive samples and 404 negative samples.



Method RT-PCR RT-PCR

Total

Results

SARA

SARS-CoV-2

Antigen Test

Kit

( Self-testing)

Results Positive Negative
Positive 4 91 14
Negative 400 10 491
Total 404 101 505

Sensitivity : 90.099%

Specificity 99.010%

Accuracy 97.228%

LOD 900 TCID50 /mL





1235

Payment & Shipping

cofoe-packing            

Packaging



98_Cofoe Medical Technology Co.,Ltd. automatic product inner and outer packing line  

FAQ           
   

Q1:Are you Trading Company or manufacturer?                

A: We are manufacturer and started our healthcare business from 2005, welcome to visit our factory any time !                


             

Q2:Can I print our logo on the products and change the color of products?                

A:Yes, we accept OEM service.                


             

Q3:Can I get a sample?                

A:Of course, but you may need to pay sample charge which will be returned after any order signed. Some stock sample will be free for you!                


             

Q4: What is the sample lead time & production lead time?                

A: the stock sample 1 day, making sample 3-5 workdays after received your sample charge. The production lead time depend on your order quantity, about 7-30 days.                


             

Q5: What’s your payment terms and trade terms?                

A: We can accept TT, Paypal, L/C at sight. 30% deposit and 70% before shipment. We'll show you the photos of the products and packages before you pay the balance.                


             

Q6: What is your terms of delivery?                

A:Fedex /DHL / UPS / TNT / EMS for sample.                

By air/sea/train for batch goods; Airport/port /station receiving.                

Customers specifying freight forwarders or negotiable shipping methods.                


             

Q7:What certificates your products have?                

A:Most of our products have CE, ISO13485 etc. Don't worry about the quality!                


             

Q8:How long is your warranty terms?                

A: Our Warranty term is 1 to 5 years guarantee. According to the product.                

       


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