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Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit

  • Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit
  • Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit
  • Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit
  • Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit
Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit
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 OEM / ODM: Available
Box Color: Yellow Temperature: 2-30°C
High Light:

Colloidal Gold Coronavirus Test Kit

,

20min Coronavirus Test Kit

,

Serum Plasma Coronavirus Test Cassette

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

 

COVID-19 Rapid Teste Kit Novel Coronavirus Colloidal Gold Antibody IgG/IgM Test Cassette

 

Main Features

 

1  Fast to get the result in 15-20 mins
2  High sensitivity and specificity
3  Simple to use
4  High Accurate (97.51%) and Reliable (Credibility interval: 95.79%~98.67%)
5  Certified by Authoritative Certification
6  Ambient Storage
7  Unique 3-line Patented Design
8

 

Meet Multiple Criteria as follows:

 

 EN ISO 13485:2016      EN 13612:2002

 EN ISO 14971:2012      EN ISO 23640:2015

 EN ISO 18113-1:2011   EN ISO 18113-2:2011

 EN ISO 15223-1:2016   EN13641:2002

 

 

Intended Use

 

COVID-19IgG/lgM Fast Diagnostic Cassette is for the detection of lgG/lgM in human serum, plasma or whole blood.

 

It is used as a supplementary test indicator for suspected cases of Novel Coronavirus negative nucleic acid detection or used combine with nucleic acid detection in the diagnosis of suspected cased, It cannot be used as the evidence for the diagnosis and exclusion of COVID-19.

 

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 0

 

Materials Required But Not Provided

 

► Timer or stopwatch

 

► Blood collection devices, for the testing of venipuncture whole blood, serum or plasma

 

► Biohazard disposal container

 

► Disposable gloves

 

► Pipette and pipette tip

 

For fingerstick samples, the following materials are required:

Alcohol pad

Sterile lancet

Sterile gauze or cotton

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 1

 

Cassette and Materials Provided

 

► Test cassette(individually pouched)

 

► Each pouch contains one cassette with one desiccant bag

 

► Diluent buffer

 

► Instruction for use

 

► Plastic dropper(optional)

 

Interpretation of Results

 

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 2

 

► 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.

 

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

 

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

 

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

 

► 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.

 

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 3

 

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:

 

NewScen Clinical Sample Information Total
Positive Negative
Positive A 129 B 0 A+B 129
Negative C 13 D 381 C+D 394
Total A+C 142 B+D 381 A+B+ C+D 523

 

Positive Coincidence Rate

 

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

 

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

 

Total Coincidence Rate: (A+D)/( A+B+ C+D)% = 97.51% (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.

 

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 4

 

Storage

 

COVID-19 IgG/IgM Rapid Diagnostic Kit should be placed in dark place at 2-30°C for 12 months from the date of manufacture.

 

Keep the test kit in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test kit once it exceeds the indicated expiration date.

 

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 5

 

Colloidal Gold Serum Plasma Antibody 20min Coronavirus Test Kit 6

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

Send your inquiry directly to us (0 / 3000)