Biobase China Detection Rapid Antigen Diagnostic Rapid Test Kit Disposal Test Detection

• Material: Plastic
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: One Year
• Logo Printing: With Logo Printing
• Transport Package: Carton
• Trademark: Biobase
• Origin: Shandong, China
• Production Capacity: 10000000 PCS/Month

Product Description

 

Product Description

 

BIOBASE Rapid Antigen Detection Kit Cassette for Patient Screening

Introduction

Rapid detection of antigen refers to the application of nucleocapsid protein-specific antibodies in the direct detection of pathogens in a sample, the result can be used as direct evidence of early identification of infection the pathogen or not, detecting a rapid (15min), convenient operation of the detection method. Applicable scenarios: Weak nucleic acid detection capabilities, insufficient detection capabilities, and places where urgent results are needed. It has been widely used in Europe, America, Asia, Africa and other regions, and together with nucleic acid testing has become an important detection method.

Features:

* The use of nasopharyngeal swab.
* Rapid detection :15 minutes out of the results.
* High accuracy
* Easy to use.

Advantage:

antigen detection can directly detect whether the human body contains, which can be detected at the early stage of virus infection. It is fast, accurate, and requires less equipment and personnel. Using double antibody sandwich method and using two antigen specific antibodies to identify and combine different epitopes of a target antigen, it can greatly reduce the number of cross reactions. So as to improve its specificity.

Sample collection:

Sample testing:

The results of judgment:
Positive: T-line and C-line present within 15-20 minutes after sample addition.
Negative: only C-line, no T-line, occurs within 15-20 minutes after dropping the sample.
Invalid: As long as there is no line C, this test card is invalid. Please use another test card to retest.


The results are summarized in the following table. The RT-PCR cycle threshold (Ct) is the relevant signal value. Lower Ct value indicate higher viral load. The sensitivity was calculated for the different Ct value range (Ct value≤33 and Ct value≤37).

Antigen	RT-PCR (Ct value≤33)		Total
	Positive	Negative
Positive	152	3	155
Negative	5	601	606
Total	157	604	761
Sensitivity (Ct≤33): 96.8% (152/157), (95%CI: 92.8%~98.6%) Specificity: 99.5% (601/604), (95%CI: 98.6%~99.7%) Accuracy: 98.9%((152+601)/761), (95%CI: 98.2%~99.5%)

Technical Parameters:

Product Name	Main composition	Testing time	Dimensions	Net Weight	Kit Size	Package Size	Gross Weight
Antigen Test Kit(Colloidal Gold)	Test card, Sample extraction buffer, Nasal swab or Throat swab	15-20min	205*120*75mm	0.3kg	20T/box 50 boxes/carton	620*430*400mm	17kg

 

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