COVID-19 Detection Kit [For Human]

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(Saliva transport kit)​

A+CheQ Saliva KIT

Permission information

This product is a specimen transport medium (l20020.01), first-class in vitro diagnostic medical device Item License No.: In vitro Jeshin No. 20-1916

Purpose of use

Use of collecting and storing/transporting samples such as viruses from saliva

Product information

• Product Name : A+CheQ Saliva Kit
• Volume: Specimen transport medium: 2 mL / tube
• Packing unit: 50ea / pack
• Components: 1ea sample transport medium, 1ea funnel
• Storage and shelf life: 12 months at room temperature
• Storage and shelf life after sampling: 15 days at room temperature or 60 days at 4°C

Caution

  • Check the product and packaging for damage before use.
  • This product is a single-use product and should not be reused, but discarded after use.
  • Only one sample is collected from one kit, and only one sample is put in one transport medium.
  • Be careful not to touch the swab head.
  • Never ingest the specimen transport medium, and if it comes into contact with your skin or gets into your eyes, wash it under running water.

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

NOTIFICATION DOWNLOAD

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