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Rapid COVID-19 Coronavirus Test Kit High Accuracy 99.99% CE Approved

Categories Coronavirus Test kit
Brand Name: CLUNGENE
Model Number: JY-128
Certification: ISO9001, CE, TUV, FDA
Place of Origin: China
MOQ: 50000 boxs
Price: $1.8~2.5 /box Negotiable as per Order Quantity
Payment Terms: T/T, Western Union
Supply Ability: 50,000 Kits Per Day
Delivery Time: 8 days
Packaging Details: The size of one box for 1 kits is 190 * 70 * 38 mm, 240 boxes /carton, the size of the carton is 59 * 40 * 58 cm, and 20.5 kg /carton
Color: white
Quantity: 1 Kit/Box
Shelf Life: 2 years
Material: plastic
Time of use: One-Off Use Only
Reading time: 10 Mintues
Specimen: swab
Type: Diagnostic Antigen rapid test kit
Sensitivity: High Accuracy 99.99%
Power Source: Manual
Package: foil pouch
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Rapid COVID-19 Coronavirus Test Kit High Accuracy 99.99% CE Approved

rapid test kit 19 for CE approved


NOTE

in the specimen. Therefore, any shade of color in the test line (T) should be considered positive. Please note that this is a
qualitative test only, and cannot determine the concentration of analyses in the specimen.
2.Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band
failure.

PERFORMANCE CHARACTERISTICS

1. Negative reference coincidence rate
Use 10 samples of Ag negative reference to test, the test results should not be positive, the negative coincidence rate should be 10/10;
2. Positive reference coincidence rate
Use 10 samples of Ag positive reference to test, the test result should all be positive, the positive coincidence rate
should be 8/10;
3. Sensitivity
Use 3 samples of Ag sensitivity reference to test, L1 should be detected, L2 should be detected or not,L3 should not be detected.
4. Repeatability
Use 1 sample of internal control repeatability reference( J1) to complete the parallel test for 10 tests, the results should be coincident.
5. Cross-reaction and interference reaction
Use positive samples of the other kinds of Infection to do the tests, the test results should be negative.
6. The Clinical study
The Ag Rapid Test has been evaluated with 155 clinical samples. Both 91 negatives and 64 positives were confirmed by PCR
The Ag Test v.s. PCR
Test Method
Viral culture results
Total
Positive
Negative
The Virus Ag Test
Positive
52
7
59
Negative
12
84
96
Total
64
91
155
[1] Sensitivity = A/(A+ C) ×100%= 81.3%
[2] Specificity = D/(B+ D) ×100%= 92.3%
[3] Crude coincidence rate= (A+D)/(A+B+C+D)×100%= 87.7%
[4] Consistency factor kappa = 0.744

Main Features:


1. Fast to get the result in 15~20 mins.


2. High sensitivity and specificity.


3. Simple to use.


4. High Accurate and Reliable


5. Ambient storage.


6. Certified by Authoritative Certification


Storage


COVID-19 IgG/IgM Rapid Test Cassette should be stored in dark place at 2-30°C for 12 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.


Warning


For in vitro diagnostic use ONLY


Read the package insert completely before use.It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false negative result (i.e.a missed positive).

Quality Rapid COVID-19 Coronavirus Test Kit High Accuracy 99.99% CE Approved for sale
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