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COVID-19 Test Kit

 

 

WHO name it as 2019-nCoV at the beginning since Jan 12th of 2020.

* 2019-nCoV = 2019 novel coronavirus

 

China Health Organization name it as NCP since Feb 7th of 2020.

* NCP = Novel Coronavirus Pneumonia

 

WHO name it as COVID-19 formally since Feb 11th of 2020. and ICTV name it as SARS-CoV-2.

* CO means Corona, VI means virus, D means disease, 19 means the outbreak is in 2019.

* ICTV = The International Committee on Taxonomy of Viruses

* SARS-CoV-2 = Severe Acute Respiratory Syndrome Coronavirus 2

 

 

 

From the experience in Wuhan, virus detection is essential for the early control of the epidemic, which can effectively prevent delays in treatment, reduce public panic and social chaos.

Our manufacturer has been a key player in the testing for SARS-CoV-2 since the outbreak. It was among the first few companies that developed the diagnostic test and received emergency approval from China’s National Medical Products Administration (NMPA) on January 26, followed by the European CE-IVD marking on February 24, the U.S. FDA-issued Emergency Use Authorization (EUA) on March 26, the Japan’s marketing approval on March 27. Our manufacturer currently boasts a daily manufacturing capacity of 2 million reactions, and is actively scaling up to meet the rapidly-growing global demand. Our manufacturer has manufactured over 10 million tests to date, and performed over 600,000 SARS-CoV-2 tests per day in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 80 countries and regions.

 

 

Real-time fluorescent RT-PCR kit for detecting 2019-nCoV

CE & FDA certfied good quality. 50 tests/kit.

* RT-PCR = Reverse Transcription - Polymerase Chain Reaction

 

Features

Samples to results in less than 3 hours.

Taqman Reverse Transcription PCR

ORF1ab gene as domain target

Human β–actin as internal control

Manufacturing in ISO 13485 compliant and high-volume production facility

Stringent QC with positive and blank controls

 

Benefits

Highly sensitive – Superior limit of detection

Highly specific– No cross-reactivity with other major human-related pathogens

Fast – One-step duplex reaction with single target and internal control

Easy to use – Pre-mixed primers, probes and enzymes

Easy to interpret results – Analysis of one target with well defined controls

 

Specifications

50 reactions per kit

Samples collected from throat swab or bronchoalveolar lavage fluid (BALF)

Compatible with many major real-time PCR systems

Limit of detection: 100 copies/mL

Reagents stable under dark for 5 days at 2-8oC or 6 months at -18oC

No cross-reactivity with human genome or 54 other human related pathogens

 

 

Intended use

The kit is a qualitative in vitro nucleic acid amplification assay to detect the new coronavirus identified in China in 2019 using Reverse transcription PCR in specimen of throat swab and Bronchoalveolar Lavage Fluid (BALF) from suspects.

In end of 2019, some pneumonia cases were reported in Wuhan, China and the pathogen was confirmed as a new strain. World Health Organization has named the newly identified coronavirus as 2019-nCoV.

Although more intensive researches must be conducted later to well understand the virus, in response to the emergency in disease control, simple and rapid kit is necessary to identify the virus timely and implement efficient interventions to contain the spread. The kit will qualitatively detect the nucleic acid of 2019-nCoV in specimen from suspects enabling to assess the infection situation of 2019-nCoV in suspects in clinical and public health practice.

 

Principle of the procedures

The kit is based on in vitro RT-PCR combining fluorescent probing. Primers and a sequence-specific fluorescence probes were designed tailored to high conservative region in 2019-nCoV genome. The probes are oligonucleotide attached fluorophores at the 5' end with FAM as reporter and 3’ end with quencher. In a meantime, specific primers and probes were developed as internal reference with fluorophores VIC/HEX attached at 5’ end as reporter. During the PCR procedures, the DNA polymerase cleaves the probe at the 5’ end and separates the reporter dye from the quencher dye when the probes hybridize to the target DNA. This cleavage results in the fluorescent signal generated by the cleaved reporter dye, which is monitored real-time by the PCR detection system. Monitoring the fluorescence intensities during Real Time allows the qualitative detection of 2019-nCoV in specimens.

 

Key components

Component (50 tests/kit) Volume Quantity Description
2019-nCoV Reaction Mix 1mL/vial 1 vial Reagents for amplification, probes and primers
2019-nCoV Enzyme Mix 80μL/vial 1 vial Taq polymerase, reverse transcriptase and uracil-DNA
glycosylase (UDG)
2019-nCoV Positive Control 750μL/vial 1 vial Mix solution of pseudo-virus with target virus genes and
internal reference
2019-nCoV Blank Control 750μL/vial 1 vial DNase/RNase free water

 

Materials required but not provided

Reagents:TIANamp Virus RNA extraction Kit (DP315-R) manufactured by TIANGEN, or QIAamp Viral RNA Mini Kit (52904) by QIAGEN.

1.5 mL RNase/DNase-free microcentrifuge tube, RNase/DNase-free tips for pipettes, 0.2mL 8-tube strips for real-time PCR, Bench centrifuge, Vortex mixer.

Notes:Components contained within a kit are intended to be used together. Do not mix components from different kit lots.

 

Storage and shelf-life

The RT-PCR Kit should be stored at temperature lower than -18oC in dark. It is stable with shelf-life at 2-8oC for 5 days and at -18oC for 6 months(tentative). Unpacked kit should avoid repeated thaw-freeze cycle (within 4 times)

The PCR Kit can be transported at -18oC in dark stable for 5 days. The manufacture date and shelf life would be provided in the labelling. The specimen should be shipped in low temperature condition using dry ice or ice bag.

 

Applicable instruments

Applied BiosystemsTM Real time PCR system 7500; SLAN-96P PCR system

 

 

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