Home > Coronavirus Test kit >

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

Product Categories

Hong Kong JYJC International Trade Limited

Contact Now

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

Name: Rapid COVID19 Coronavirus Test Kit High Accuracy 9999 CE Approved
Brand: CLUNGENE
Price: 1.8 USD

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

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

Contact Now

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

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

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).

Product Tags: