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.
Biokey
Multiple Respiratory PCR testing solution.p...
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:
1.The kit should be stored under -20±5℃ and protected from light.
Its period of validity is 12 months. Products can be shipped at
room temperature for 7 days.
2.Repeated thawing and freezing should be no more than 3 times.
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 |
Select the detection channels as following:
Select FAM,VIC/HEX,ROX and CY5 channels
Quality control:
Negative Control: None of the FAM, VIC/HEX, ROX & IC (CY5) channels
have a Ct value or Ct ＞ 40;
Positive Control: FAM, VIC/HEX, ROX & IC (CY5) channels Ct ≤ 30;
The above two items should be met simultaneously in one experiment.
Otherwise, the experiment is invalid and should be repeated.
Interpretation of test results:
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
