Sputum Nucleic Acid Test Kit QRT-PCR CE Saliva Antigen Test Kit

CE Certified COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (sputum)

Product info

Product description

This kit is used for in vitro detection of viral RNA of novel coronavirus (SRAS-COV-2) ORF1ab and E genes in the oropharyngeal swab, nasopharyngeal swab and sputum from individuals who are suspected of COVID-19 by their healthcare provider, who are among cluster of COVID-19 cases, or who have other diagnostic needs determined by their healthcare provider.

Test results of this kit are for clinical reference only, and should not be used as the sole criteria for clinical diagnosis and patient management decision. It is recommended to conduct a comprehensive examination on the patient condition in combination with clinical observations, patient history and epidemiological information.

This kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques required for performing the test and in vitro diagnostic procedures.

Core advantage

Our CE Certified COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (sputum) is targeted at ORF1ab, RNase P and E gene (based upon latest research from US FDA, COVID Omicron has mutation in N genes and S genes, and significantly lower the detection rate of the kits which target on these genes). But so far, there is no evidence to show that E gene has mutation occurred in Omicron. Therefore, our test kit can detect COVID Omicron as efficient as COVID Delta, Alpha, etc.

Parameter

Component

Storage condition

Storage Temperature: -20±5℃

Shelf life: 12 months

Workflow

1. Reagent Preparation

Remove the kit, melt it at room temperature and mix it with shaking, then centrifuge it at low speed for 10 seconds, and calculate the number of reagents to be prepared for each person (n=number of samples + 2 tubes of control). The reaction system per person was prepared as follows.

Reaction solution preparation table (per person)

Add to an appropriate volume of centrifuge tube, mix thoroughly, and dispense into n PCR reaction tubes in 15µL amounts.

2. Sample Treatment

2.1. Nucleic acid extraction: Take the sample to be tested, the positive control and the negative control, and extract the sample according to the instructions of the nucleic acid extraction kit.

2.2. Sample addition: Add 10uL each of the extracted sample, positive control and negative control to the PCR reaction tubes prepared above, with a final volume of 25uL/ tube, cap tightly and centrifuge instantaneously at low speed.

3. RT-PCR amplification

3.1. Place the reaction tube into the sample slot of the fluorescent PCR amplifier.

3.2. Set the positive control, negative control and sample to be tested in the corresponding order, and set the sample name.

3.3. Select three detection channels, FAM, VIX and ROX. FAM is the ORF1ab indicator channel, VIX is the E gene indicator channel, and ROX is the internal standard RNaseP indicator channel.

3.4. Perform the amplification assay.

Applicable Instrument

QuantStudio 5 Real Time PCR System

HiMedia Insta Q96 Plus Real Time PCR