SARS-CoV-2 / Influenza A+B RT-PCR test kit (Lyophilized)
Intended use:
This kit is used for in vitro qualitative detection of
SARS-CoV-2/Influenza A+B 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,
the primer probes, together with RT-PCR reaction solutionfor
fluorescent detection are designed and labeled with different
fluorescent groups. On the fluorescence quantitative PCRinstrument,
the real-time fluorescence quantitative PCR
detec tion technology is used to realize the rapid detection of
SARS-CoV-2/Influenza A+B 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:
| No. | Components | BIK-QL-H010S |
| 1 | PCR Enzyme Mix (Lyophilized) | 48 tests/kit |
| 2 | Primer-Probe Mix | / |
| 3 | Enzyme Mix Buffer (5×) | / |
| 4 | Positive Control | 100 μL/tube |
| 5 | Negative Control | 100 μL/tube |
| 6 | RNase-free water | 1mL/tube |
| 7 | 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 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
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 |
Select the detection channels as following:
Select FAM,VIC/HEX,ROX and CY5 channels
Performance Indexes:
1. Accuracy
Use national reference products or enterprise positive/negative
reference products for testing, and the results are all
positive/negative.
2. Precision
The coefficient of variation (CV) of CT value is ≤5.0%.
3. Detection limit: 500 copies/mL.
Operation details please check from IFU
