Multiplex Molecular Diagnosis Human Respiratory System Real Time PCR Kit Lyophilized
Multiplex Respiratory viral RT-PCR test kit (Lyophilized)
Intended use:
This kit is used for in vitro qualitative detection of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae from patients with respiratory tract infection. The test results are for clinical reference only, it cannot be used alone as the basis for the diagnosis or exclusion of cases.
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:
| No. | Components | Amount |
| 1 | PCR Enzyme Mix (Lyophilized) | 96 tests/bottle |
| 2 | Primer-Probe Mix 1 (SARS-CoV-2/Influenza A+B ) | 50 μL/vial |
| 3 | Primer-Probe Mix 2 (RSV/Adenovirus/M.pneumoniae) | 50 μL/vial |
| 4 | Enzyme Mix Buffer (5×) | 400 μL/vial |
| 5 | Positive Control | 100 μL/tube |
| 6 | Negative Control | 100 μL/tube |
| 7 | RNase-free water | 1mL/tube |
| 8 | Paraffin oil | 1.5mL/tube*2 |
2. BIK-QL-H004S:
| No. | Components | Amount |
| 1 | 1 (SARS-CoV-2/Influenza A+B Mix (Lyophilized)) | 24 tests/kit |
| 2 | 2 (RSV/Adenovirus/M.pneumoniae Mix (Lyophilized)) | 24 tests/kit |
| 3 | Positive Control | 100 μL/tube |
| 4 | Negative Control | 100 μL/tube |
| 5 | RNase-free water | 1mL/tube |
| 6 | Paraffin oil | 1.5mL/tube |
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:
| Step | Cycle number | Temperature | Time |
| 1 | 1 | 50℃ | 10min |
| 2 | 1 | 94℃ | 3min |
| 3 | 40 | 94℃ | 10s |
| 60℃ | 30s Collect the fluorescent |
Interpretation of test results:
( 1)SARS-CoV-2/Influenza A+B reaction:
|
FAM (SARS-CoV-2) |
VIC/HEX (Influenza A) |
ROX (Influenza B) |
CY5 (IC) |
Interpretation test results | |
| 1 | - | - | - | - | Result invalid ,test again |
| 2 | + | - | - | +/- | SARS-CoV-2 (+) |
| 3 | - | + | - | +/- | Influenza A(+) |
| 4 | - | - | + | +/- | Influenza B(+) |
| 5 | + | + | - | +/- | SARS-CoV-2 ,Influenza A(+) |
| 6 | + | - | + | +/- | SARS-CoV-2 ,Influenza B(+) |
| 7 | - | + | + | +/- | Influenza A+B(+) |
| 8 | + | + | + | +/- | SARS-CoV-2 ,Influenza A+B(+) |
| 9 | - | - | - | + | Negative(-) |
(2)RSV/Adenovirus/M.pneumoniae reaction:
|
FAM (RSV) |
VIC/HEX (Adenovirus) |
ROX (M.pneumonia) |
CY5 (IC) |
Interpretation test results | |
| 1 | - | - | - | - | Result invalid ,test again |
| 2 | + | - | - | +/- | RSV(+) |
| 3 | - | + | - | +/- | Adenovirus(+) |
| 4 | - | - | + | +/- | M.pneumonia(+) |
| 5 | + | + | - | +/- | RSV,Adenovirus(+) |
| 6 | + | - | + | +/- | RSV,M.pneumonia(+) |
| 7 | - | + | + | +/- | Adenovirus, M.pneumonia (+) |
| 8 | + | + | + | +/- | RSV, Adenovirus, M.pneumonia(+) |
| 9 | - | - | - | + | Negative(-) |
Operation details please check from IFU!
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