Multiplex Molecular Diagnosis Human Respiratory System Real Time PCR Kit Lyophilized

Multiplex Respiratory viral RT-PCR test kit (Lyophilized)

Intended use:

Test Principle:

The kit adopt TaqMan fluorescent probe method. For the highly conserved and specific region of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae, the primer probes, together with RT-PCR reaction solutionfor fluorescent detection are designed and labeled with different fluorescent groups. On the fluorescence quantitative PCR instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae through the change of fluorescent signal.The detection system contains positive internal control, used to monitor whether the nucleic acid extraction process is normal.The kit adopt TaqMan fluorescent probe method. For the highly conserved and specific region of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae, the primer probes, together with RT-PCR reaction solutionfor fluorescent detection are designed and labeled with different fluorescent groups. On the fluorescence quantitative PCR instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae through the change of fluorescent signal.The detection system contains positive internal control, used to monitor whether the nucleic acid extraction process is normal.

Product components:

1. BIK-QL-H004:

2. BIK-QL-H004S:

Note: Do not mix the components from different batches for detection. The Positive Control of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae and internal control were constructed artificially, and they were not infectious.

Storage and stability:

Specimen requirements:

1. Specimen type

Throat swab, nasal swab, nasopharyngeal swab, alveolar lavage fluid and sputum.

2. Specimen preservation

The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃.

PCR amplification condition:

PCR amplification according to the following procedure:

Interpretation of test results:

( 1)SARS-CoV-2/Influenza A+B reaction:

(2)RSV/Adenovirus/M.pneumoniae reaction:

Operation details please check from IFU!

Bio key Health is a high-tech enterprise with integrating R&D, production and sales&marketing in Guangzhou. Since 2003. Bio Key was founded by the "Thousand Talents Program" entrepreneurial team and the overseas senior automation equipment development engineer team.

The company's core team has been in the field of IVD research and entrepreneurship for more than 10 years, and has mastered a wealth of molecular diagnostic POCT industrial application technology, SmartTRF immune detection technology, RT qPCR nucleic acid detection technology and independent research and development capabilities of instruments.

It has a number of independent core technologies in the fields of automation engineering, micro-precision manufacturing, immunofluorescence, nucleic acid detection and gene sequencing. Since its establishment, the company has applied for more than 60 patents and currently has 17 authorized patents. The company has two R&D centers for diagnostic reagents and instruments and equipment, totaling more than 500 square meters; it has established more than 2,000 square meters of GMP workshops and equipment production plants; it has SmartTRF new immune detection technology, nucleic acid detection technology (POCT) and three scientific services.