Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (Real-time PCR)


Background and epidemiology

Coronavirus is a single stranded positive RNA virus, which belongs to the orthocoronavirus subfamily of coronaviridae in Nidovirales. Some of them can cause human diseases (such as common cold, severe acute respiratory syndrome [SARS], Middle East respiratory syndrome [MERS]).

Since December 2019, novel coronavirus infection has been identified as a new respiratory tract infectious disease in a number of cases of unknown causes pneumonia in some hospitals in Wuhan, Hubei.

In January 12, 2020, novel coronavirus (novel coronavirus) (2019-nCoV) was officially named as "2019 new coronavirus" (WHO) by the WHO.

Intended use

The novel coronavirus (2019-nCoV) novel coronavirus (PCR) gene is relatively conservative ORF1ab and N genes are used as target areas for amplification. The primers and probes are designed by one-step RT-PCR amplification. The new coronavirus (2019-nCoV) RNA is detected in the clinical samples by changing the fluorescence signal.

This kit is suitable for the qualitative detection of novel coronavirus (SARS-CoV-2) nucleic acid RNA in clinical samples.

Specimen Requirements

Sample type: Human nasopharyngeal swab, sputum, lower respiratory tract specimens (tracheal secretions, tracheal aspiration, alveolar lavage fluid)
Sample collection: For specific methods of sample collection, please refer to the "microbial specimen collection manual".

Storage and transportation of samples: Storage at 2-8 °C for no more than 24 hours; Keep under -20±5 °C for no more than 3 months; Keep for a long time at -70°C or below; Avoid repeated freeze-thaw. Samples are transported in sealed curling bottles or in sealed foam boxes with ice.

Precision

 CV≤5% 

Package Specifications

Large package, 48 tests / kit.

Applicable Instruments

ABI 7500 system

Test Principle

This kit is based on real-time fluorescence PCR technology. The conservative ORF1ab gene and N gene of new coronavirus (SARS-CoV-2) are choosed as the target amplification area. Specific primers and probes are designed and one-step RT-PCR amplification is performed. Through the change of fluorescent signal, the 2019 Novel Coronavirus RNA in the specimens are detected.

Storage Conditions and Validity Date

The kit is stored at -20±5°C away from light for 12 months.
Stability after opening: Stable for 3 days at 2 ~ 8°C.
Freezing-thawing stability: Repeated freezing-thawing (box -20±5°C/ room temperature re- thawing) for 5 times.
The production date and expiry date are shown in the package label.

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All certification can be provided upon request. Please reach out to our account executives at info@apeironmed.com or give us a call at +855 (0)85 555 792.