Rapid COVID-19 Coronavirus Test Kit High Accuracy 99.99% CE Approved
Brand Name:CLUNGENE
Certification:ISO9001, CE, TUV, FDA
Model Number:JY-128
Minimum Order Quantity:50000 boxs
Delivery Time:8 days
Payment Terms:T/T, Western Union
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Location:
Hong kong China
Address:
Room 616, 6 / F, Kam Tin Industrial summer, 135 Connaught Road West, West, Hong Kong
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Product Details
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.
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
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
[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
[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).
Rapid COVID-19 Coronavirus Test Kit High Accuracy 99.99% CE Approved
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