PEI/Bfarm listed COVID 19 Antigen professional/Self Rapid Test

Short Description:

PEI/Bfarm listed COVID 19 Antigen professional/Self Rapid Test

Used For COVID 19 Antigen Self Test Kit
Specimen Nasal Swab or Saliva
Certification CE/ISO13485/White List/PEI certified/Befarm
MOQ 1000 test kits
Delivery time 1 week after Get payment
Packing 1 test kits/Packing box5 test kits/packig box20 test kits/packing box
Test Data Over 95% Sensitivity and Specificity
Shelf Life 2 years
Production Capacity 1 Million/Week
Payment T/T, Western Union, Paypal

 


Product Detail

Product Tags

PEI/Bfarm listed COVID 19 Antigen professional/Self Rapid Test

Used For COVID 19 Antigen Self Test Kit
Specimen Nasal Swab or Saliva
Certification CE/ISO13485/White List/PEI certified/Befarm
MOQ 1000 test kits
Delivery time 1 week after Get payment
Packing 1 test kits/Packing box5 test kits/packig box20 test kits/packing box
Test Data Over 95% Sensitivity and Specificity
Shelf Life 2 years
Production Capacity 1 Million/Week
Payment T/T, Western Union, Paypal

 COVID Self Test COVID 19 Test

SHORT INTRODUCTION

SARS-CoV-2 antigen rapid detection method is a method to detect SARS-CoV-2 antigen. The anti-SARS-CoV-2 monoclonal antibody is coated on the test line and combined with colloidal gold. During the test, the sample reacts with the anti-SARS-CoV-2 antibody conjugate in the test paper. Then, the mixture migrates upward on the membrane by capillary action and reacts with another anti-SARS-CoV-2 monoclonal antibody in the test area. The composite is captured and forms a colored line in the test line area. The rapid detection of SARS-CoV-2 antigen contains anti-SARS-CoV-2 monoclonal antibody binding particles, and another anti-SARS-CoV-2 monoclonal antibody is coated in the detection line area.

COVID Antigen Test COVID_Self_Test2

Features
A. High Sensitivity and Specificity
B. Available for professional and self test
C. PEI certification

D. Bfarm listed for both Self and professional Test

D. ANMAT Certified

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Preventive Measure

-Only for in vitro diagnosis. Do not use after expiration.

-The test box shall be kept in the sealed bag until it is used.

-Treat all specimens as if they contain infectious pathogens. Follow established precautions against microbial hazards throughout the process and follow standard procedures for proper disposal of specimens.

-When testing specimens, please wear protective clothing, such as laboratory coat, disposable gloves and goggles.

-Used test strips should be discarded in accordance with national, state and local regulations.

-Humidity and temperature can adversely affect the results.

Storage and Stability

The kit can be stored at room temperature or refrigerated (2-30 days) ° C)。 The test strip is stable during the period of validity printed on the sealed bag. The test box must remain in the sealed bag until it is used. Don’t freeze. Do not use beyond the validity period. The stability of the kit under these storage conditions was 18 months

Specimen collection and preparation

Rapid detection of sars-cov-2 antigen (covid-19 Ag) can be performed with nasopharyngeal or oropharyngeal swabs, nasal swabs and saliva.

Nasopharyngeal swab: insert the sterile swab deep into the nasal cavity to the nasopharynx. Rub and rotate the swab gently on the concha wall several times.

· oropharyngeal swab: insert a sterile swab into the throat. Gently scrape the secretion around the pharynx and tonsil wall.

Nasal swab: insert the sterile swab into one of the nostrils about 2.5 cm. Rub the front wall gently and repeat in the other nostril.

Saliva: prepare a specimen collection container. Make a “kruuua” sound from the throat and expel saliva or sputum from the depth of the throat. Then spit the saliva (about 1-2ml) into the container. Morning saliva is best for collecting saliva. Do not brush your teeth, eat or drink before collecting saliva samples.

 

Remove from the buffer tube and tear off the tube head. Squeeze all the liquid (about 0.5ml) into the specimen collection tube. Insert the swab into the tube and squeeze the hose to squeeze the specimen out of the swab head. The sample was dissolved completely in the determination buffer. Add the tip to the sample collection tube. If it is a saliva sample, suck saliva out of the container, and then put 5 drops (about 200ul) of saliva into the sample collection tube.

The test should be carried out within 2 hours after sample preparation. If the test cannot be carried out immediately, the sample should be prepared within 2-8 hours ° Store at – 20 ℃ for 24 hours or less ° It should be stored for no more than 7 days under C.

Place the sample at room temperature before testing. Frozen samples must be completely thawed and mixed before testing. The specimens should not be frozen and thawed repeatedly for more than two times.

If specimens are to be transported, they should be packaged in accordance with federal regulations covering the transportation of pathogens.

 

Test procedure

Balance the test equipment, sample, buffer and / or control to room temperature (15-30 ℃) before testing ° C)。

1. Place the bag at room temperature before opening. Remove the test device from the sealed bag and use it as soon as possible.

2. Place the test equipment on a clean and level surface. Reverse the sample collection tube, squeeze 3 drops of the prepared sample into the sample hole (s) of the test box, and start the timer.

See the figure below.

COVID Antigen Test Kit

3. Wait for the colored line(s) to appear. Read results at 10 minutes.

Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

COVID Self Test

-Positive (+): two colored lines appear. One color line should always appear in the control line area (c) and the other in the T line area.

*Note: the color intensity of the test line area may vary depending on the concentration of sars-cov-2 present in the sample. Therefore, any shade of color in the test line area should be considered positive and recorded as positive.

-Negative (-): a color line appears in the control line area (c). There is no line in the T-line area.

-Invalid: the control line does not appear. Insufficient sample size or incorrect program technology are the most likely causes of control line failure. Review the program and repeat the test with the new test. If the problem persists, stop using the test suite immediately and contact your local dealer.


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