COVID-19 Detection Kit [For Human]

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(Products approved by notification of application for emergency use)

A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit RR001

Permission information

Approval for emergency use of medical devices for in vitro diagnosis by the Ministry of Health and Welfare (KCDC Notice No. 2020-701)

Purpose of use

Qualitative detection of SARS-COV-2 gene (ORF1ab, N gene) in samples (nasopharyngeal and oropharyngeal specimens) from patients suspected of protective respiratory infectious disease by real-time RT-PCR to detect COVID-19 Used for emergency screening

Product information

• Product Name: A+CheQ COVID-19 High-Speed ​​RT-Qpcr Detection Kits

• Model Name: RR001

• Packaging unit: 100 Test/kit
• Storage temperature: -24 degrees to -18 degrees
• Product validity period: 6 months
• Caution: Do not freeze/thaw reagents more than 3 times.

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

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