IVDR Covid 19 PCR Test Molecular Diagnostic Saliva Antigen Test Kit

Basic Information
Place of Origin: Nanjing,China
Brand Name: Bunnyteeth
Certification: CE/IVDR
Minimum Order Quantity: 50 Tests
Price: 2.0 USD / Test
Packaging Details: Foam Box Package
Payment Terms: T/T, L/C, Western Union
Supply Ability: 50000 Tests / Day
Specification: 50 Tests Storage Temperature: -20 ℃±5℃
Shelf Life: 12 Months Sample Type: Saliva
Application: Detect COVID Delta Downstream Application: DdPCR,
Methodology: PCR, Target: ORF1ab, E Gene, RNase P
Processing: Semi-automatic Time Per Run: 30-60 Minutes
PCR Reaction Solution Volume: 14 μL PCR Enzyme Mix Volume: 1 μL
Reaction Mix Volume: 15 μL Positive Control Volume: 10 μL
Negative Control Volume: 10 μL PCR Reaction Plate: 48-well, 96-well, 192-well, 384-well
Supporting Platform: Bio-Rad CFX 384;Biosystems PCR 7500;Agilent Mx3000P QPCR System Eppendorf Mastercycler X50 PCR Cycler Reference Range: Ct>40
LoD: 500 Copies/ ML CV: <5%
PPA: >95% NPA: >95%
Specificity: >99% Detection Rate: >85%
Production: GMP Production Quality System: ISO13485: 2016
OEM/ODM: Support
High Light:

50 tests Covid 19 PCR Test

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IVDR Covid 19 PCR Test

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Molecular Diagnostic saliva antigen test kit

COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (saliva)

Product info

Product name Specification
COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (saliva) 50 tests 

 

Product description

This kit is used for in vitro detection of viral RNA of novel coronavirus (SRAS-COV-2) ORF1ab and E genes in the oropharyngeal swab, nasopharyngeal swab and sputum from individuals who are suspected of COVID-19 by their healthcare provider, who are among cluster of COVID-19 cases, or who have other diagnostic needs determined by their healthcare provider.

 

This kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques required for performing the test and in vitro diagnostic procedures.

 

Core advantage

Our COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (saliva) is targeted at ORF1ab, RNase P and E gene (based upon latest research from US FDA, COVID Omicron has mutation in N genes and S genes, and significantly lower the detection rate of the kits which target on these genes). But so far, there is no evidence to show that E gene has mutation occurred in Omicron. Therefore, our test kit can detect COVID Omicron as efficient as COVID Delta, Alpha, etc.

 

Parameter

IVDR Covid 19 PCR Test Molecular Diagnostic Saliva Antigen Test Kit 0

 

Component

Component Name

Specifications

(50 reactions/kit)

Quantity Main Composition
SARS-CoV-2 PCR Reaction Solution 700ul/vial 1 vial Primers, probes, dNTP, MgCl2, etc.

SARS-CoV-2 PCR Enzyme

Mix

50μl/vial 1 vial Reverse transcriptase, DNA polymerase, RNase inhibitor, uracil-N-glycosylase, etc.
Positive Control 600μl/vial 1 vial Virus-like particles of SARS-CoV-2
Negative Control 600μl/vial 1 vial Nuclease-free water

 

Storage condition

The kit should be stored at -20±5℃ in dark and is stable for 12 months. Repeated freeze-thaw cycles should be avoided. See the product label for the date of manufacture and expiration of the kit.

 

Workflow

IVDR Covid 19 PCR Test Molecular Diagnostic Saliva Antigen Test Kit 1

 

Applicable Instrument

 

Agilent Mx3000P qPCR System

Eppendorf Mastercycler X50 PCR Cycler

 

 

Contact Details
International Senior BD Manager

Phone Number : +8615295035903

WhatsApp : +8615295035903