COVID-19 Detection Kit [For Human]

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(Sample transport kit)​

A+CheQ VTM KIT

Permission information

This product is a one-piece medical device
  • Specimen transport medium (l20020.01) Item permission number: In vitro Jeshin No. 20-1356
  • Specimen collection tool (A66110.02) Item permission number: No. 20-1489

Purpose of use

For collecting and storing samples such as viruses from the nasal cavity and oral cavity

Product information

• Product name : A+CheQ VTM Kit
• Volume: Specimen transport medium: 2 mL / tube
• Packing unit: 50ea / pack
• Components: 1ea sample transport medium, 1ea swab for nasal use, 1ea swab for oral use
• 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

  • Inspect 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 with one Swab, and only one sample is placed on 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
  • Do not use products with damaged storage tubes or lids, or products whose lids are not sealed when first opened.

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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