COVID-19 Detection Kit [For Human]

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A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit

A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit is an In Vitro Diagnostic (IVD) Reagent for detection of SARS-CoV-2 from COVID-19 suspected patients. High-Speed, High Accuracy IVD Reagent Kit that can detect ORF1ab and N genes of SARS-CoV-2 within 30 minutes.
CE_IVD

Reagent type and Capacity

 Reagent typeQuantityCapacity (μl)
14X Master mix1500
2Oligo mix (ORF1ab)
1300
3Oligo mix (N)1300
4Oligo mix (Internal control)1400
5Positive control1500
6Negative control
(DNase, RNase free water)
1500

Process

Specification

Detection target SARS-CoV-2
Target region ORF1ab, N gene
PCR running time 29 mins
Detection technology Real-Time Reverse transcript PCR
Specimen type Nasopharyngeal swab, Oropharyngeal swab
Compatible instrumentsCFX96™ Real-Time PCR System (Bio-Rad)
QuantStudio™5 Real-Time PCR System (Applied Biosystems)

Ordering Information

Cat no.
ProductSize
RR001A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit 100 tests/kit

The test’s performance characteristics

Analytic Sensitivity of Limit of Detection
Testing concentration (Copies/㎕)Replicate
QuantStudio™5 Real-Time PCR system
CFX96 Real-Time PCR system
N geneORF1ab geneRNase P geneN geneORF1ab geneRNase P gene
Ct ValueCt ValueCt ValueCt ValueCt ValueCt Value
1002036.8032.3724.7138.1234.7028.19
Positive / total20 / 2020 / 2020 / 2020 / 2020 / 2020 / 2020 / 20
Detection rate , %100%100%100%100%100%100%100%

Clinical Evaluation
Nasopharyngeal / Oropharyngeal (throat) swabComparator test
PositiveNegativetotal
A+CheQ COVID-19 High-Speed RT-qPCR Detection KitPositive42042
Negative04242
total424284
Positive Agreement(PPA) : 42/42, 100% (95% CI, 91.62% – 100%)
Negative Agreement(NPA) : 42/42, 100% (95% CI, 91.62% – 100%)

Cross-Reactivity
MicroorganismsResults
Human Coronavirus NL63Not detected of SARS-CoV-2 Gene
HCoV- OC43
HCoV-HKU1
HCoV- 229E
HCoV- MERS
HCoV- SARS
Influenza A virus (H1N1)
Influenza A virus (H3N2)
Influenza B virus
Respiratory syncytial virus
Adenovirus type1
Mycobacterium tuberculosis gDNA
Streptococcus pneumonia gDNA
Salmonella Typhimurium
Human RNA

Key Benifits

We have developed various COVID-19 diagnostic tools through continuous research. Each diagnostic tool has the same accuracy. However, the time taken to present the diagnostic results varies from at least 20 minutes to up to 150 minutes.
All transactions are made with a contract. Use contracts written in English in common. After completing the contract, we will pay the payment in the manner indicated in the contract and ship the product within the time limit.

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