COVID-19 Detection Kit [For Human]

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(Product approved for export licensed)

A+CheQ COVID-19 RT-qPCR kit for Swab/Sputum/Saliva (RR004)

Permission information

Products approved for regular use by the Ministry of Food and Drug Safety (in vitro diagnostic license No. 21-816)

  • Ministry of Food and Drug Safety Approval No. 21-816
  • Approval for export licensed
  • Permit Date: Sep 30, 2021

Purpose of use

Using RNA nucleic acids extracted from upper respiratory (oropharyngeal/nasopharyngeal) smears, lower respiratory tract (sputum) and saliva samples collected from patients suspected of COVID-19 as a molecular diagnostic reagent for in vitro diagnostic medical devices that help diagnose COVID-19, It is an in vitro diagnostic medical device for qualitatively detecting genes (ORF1ab, N gene) through real-time reverse-transcription PCR.

Product information

• Product Name: A+CheQ COVID-19 RT-qPCR kit for Swab/Sputum/Saliva

• Model Name: RR004

• Packaging unit: 100 Test/kit

• Storage temperature: -24°C ~ -18 °C, Store away from light (direct sunlight).

• Product validity period: 12 months from date of manufacture

Sample odor
Nucleic Acid Extraction KingFisher Prep [Applied Biosystem]
PCR test QuantStudio 5 [Applied Biosystem]
Check the result

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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