COVID-19 Detection Kit [For Human]

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(긴급사용 신청 공고 승인제품)

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

허가정보

보건복지부 체외진단용 의료기기 긴급사용 승인 (질병관리본부 공고 제2020-701호)

사용목적

보호흡기 감염병 의심환자의 검체(비인두 및 구인두 가검물)에서 SARS-CoV-2 유전자 (ORF1ab, N gene)을 실시간 역전사 중합효소 연쇄반응법(Real-time RT-PCR)으로 정성 검출하여 COVID-19 응급용 선별 검사에 사용

제품정보

• 제품명 : A+CheQ COVID-19 High-Speed RT-Qpcr Detection Kits

• 모델명 : RR001

• 포장단위 : 100 Test/kit

• 저장온도 : -24도~-18도

• 제품유효기간 : 6개월

• 주의사항 : 3번 이상 시약 냉/해동 금지

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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