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TUV 98.67% Credibility Coronavirus Rapid Test Cassette

TUV 98.67% Credibility Coronavirus Rapid Test Cassette

  • TUV 98.67% Credibility Coronavirus Rapid Test Cassette
  • TUV 98.67% Credibility Coronavirus Rapid Test Cassette
TUV 98.67% Credibility Coronavirus Rapid Test Cassette
Product Details:
Place of Origin: China
Brand Name: Newscen
Certification: ISO9001, CE, TUV, FDA
Model Number: COVID-19 IgG/IgM
Payment & Shipping Terms:
Minimum Order Quantity: 10 Boxes or 400 Kits (40 Kits/Box)
Price: Negotiable as per Order Quantity
Packaging Details: 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Delivery Time: 8 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 50,000 Kits Per Day
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Detailed Product Description
Methodology: Colloidal Gold Specimen: Serum, Plasma, Whole Blood
Usage: For In Vitro Diagnostic Use Only Certificate: ISO9001, CE, TUV, FDA
High Light:

TUV Coronavirus Rapid Test Cassette

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Colloidal Gold Rapid Test Cassette

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98.67% Coronavirus Test Kit

Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette

 

Main Features:

 

TUV 98.67% Credibility Coronavirus Rapid Test Cassette 0

 

Intended Use

 

The kit is used to detect the lgM and lgG antibodies to severe acute respiratory Syndrome corona virus 2 (SARS CoV-2) in human serum, plasma or whole blood sample qualitatively. Itis to be used as an aid in the diagnosis of coronavirus infection disease (COVID- 19), which is caused bySARS-COV-2. The test provides preliminary test results. Negative results don't preclude SARSCOV-2 infection and they cannot be used as the sole basis for treatment or similar decision.

 

TUV 98.67% Credibility Coronavirus Rapid Test Cassette 1

 

Sample Collection and Test Preparation

 

Finger stick Specimens (Whole Blood)

 

1. Clean the area to be lanced with an alcohol pad

 

2. Squeeze the end of the fingertip and pierce it with a sterile lancet.

 

3. Wipe away the first drop of blood with sterile gauze or cotton; collect the sample from the second drop

 

4. Use dropper to draw the fresh blood to 1/ 2 of the tube wall and dispense into the sample well

 

Fingerstsick whole blood should be used immediately after can be used.

 

Serum/Plasma specimens:fresh serum or plasma specimen can be used.

 

Plasma

 

1. Collect whole blood into a collection tube (containing EDTA, Na-citrate or heparin) by venipuncture

2. Separate the plasma by centrifugation.

 

Serum

 

1. Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture.

2. Allow the blood to clot.

3. Separate the serum by centrifugation.

 

Avoid the use of hemolytic, turbid, microorganism contaminated specimens. Specimen should be stored at 2-8℃for up to3 days or frozen at -20℃for up to 9 days. Avoid specimen deterioration by multiple freeze-thaw cycles

 

Venipuncture Whole Blood

 

Venipuncture whole blood can be used immediately after collection or stored up to 3days at 2-8℃

 

Interpretation of Results

 

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1. Positive of lgG and IgM: if three lines appear in their respective zone C, G, M, then it Indicates IgG and IgM test result is positive.

 

2. Positive of lgM: if two lines respectively appears in the line of Zone C and M, It indicates IgM test result is positive.

 

3. Positive of IgG: if two lines respectively appears in the line of Zone C and G, It indicates lgG test result is positive.

 

4. Negative of lgG and IgM: if Only one color line in the control zone C it indicates IgG and IgM test result is negative.

 

5. Invalid: If no color line appears in the control zone C, then the test is invalid. Discard the test cassette and resume the performance with new cassette through correct procedures.

 

Sensitivity and Specificity

 

A total of 523 clinical samples were tested for validation, of which 142 were positive and 381 were negative. The test results are as follows:

 

TUV 98.67% Credibility Coronavirus Rapid Test Cassette 3

 

Positive Coincidence Rate:

 

Positive Coincidence Rate: A/(A+C)%=90.85% (95% Credibility Interval: 84.85% ~95.04%)

 

Negative Coincidence Rate: D/(B+D)%=100.00% (95% Credibility Interval: 99.04%~100.00%)

 

Total Coincidence Rate: (A+D)/( A+B+ C+D)% = 97.51% (95% Credibility interval: 95.79%~98.67%)

 

Built-In Control

 

IgG/lgM Rapid Test Cassette has a built-in procedural control to see whether or not the operation is correct or effective, if one color line appeared on the control zone C, it indicates that the test operation is Correct.

 

TUV 98.67% Credibility Coronavirus Rapid Test Cassette 4

 

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) .

 

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.

 

TUV 98.67% Credibility Coronavirus Rapid Test Cassette 5

 

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Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

Send your inquiry directly to us (0 / 3000)