15mins Reading One Step Covid POCT Covid-19 2019-NCoV Antigen Rapid Test Kit
Intended use
This kit uses Real-time RT PCR technology (rRT-PCR) for qualitative detection of SARS-CoV-2 nucleic acids in human nasopharyngeal or oropharyngeal swab samples.
Principle of testing
This primer and probe sets are designed for the detection of the conserved sequences of SARS-CoV-2 (ORF1ab gene, N gene and E gene). The kit contains an Internal Control that is used to assess specimen quality. Real-Time PCR technology utilizes polymerase chain reaction (PCR) for the amplification of specific target sequences and target specific probes for the detection of the amplified RNA. The probes are labelled with fluorescent reporter and quencher dyes.
◮ Specifications: 48 Rxns/kit, 96 Rxns/kit
◮ Specifificity:96.72%
◮ Sensitivity:97.92%
◮ Applicable specimen types
Nasopharyngeal Swab or Oropharyngeal Swab
◮ Applicable instrument
ABI7500, Bio-Rad CFX96, Roche LightCycler 480, SLAN-96S
INTEND USE
The rapid test kit is used for qualitative determination of novel coronavirus (SARS-CcV-2) antigen in human nasal swab samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.
MAIN COMPONENTS
• Test Cassette.
• Extraction Tube.
• Extraction Reagent.
• Nasal/Oral Swab.
• Working Holder.
HOW TO PERFORM THE TEST?
1. Remove a Test Device from the foil pouch by tearing at the notch and place it on a level surface.
2. Holding Extraction Reagent bottle vertically, add 10 drops (400μL) to the Extraction tube.
3. Insert the nasopharyngeal (and oropharyngeal) swab sample(s) into the extraction solution, then, mix the swab 10 times.
4. Remove the swabs while pressing against the solution tube in order to extract most of the specimen
5. Place the dropper cap and drop 3 drops (60~70μl) into the sample well.
6. Read the result in 10-15 minutes. Do not read results after more than 20 minutes.
Product Tags:
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