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| Categories | Respiratory PCR Test |
|---|---|
| Brand Name: | Biokey |
| Model Number: | BIK-QL-H004S |
| Certification: | ISO 13485,CE |
| Place of Origin: | Guangzhou China |
| MOQ: | We can produce liquid and lyophilized kits |
| Price: | USD |
| Payment Terms: | L/C, T/T, Western Union |
| Supply Ability: | 100,000 per day |
| Delivery Time: | Depending on order quantity |
| Packaging Details: | Carton package |
| Package: | 48 tests/kit(single tube) |
| expiration date: | 12 months |
| Storage: | -20±5℃ |
| Applicable: | Micgene 244/244 IVD(BIO-KEY) |
| Detection limit: | 500 copies/mL |
| CV: | ≤5% |
| Company Info. |
| Guangzhou BioKey Healthy Technology Co.Ltd |
| Verified Supplier |
| View Contact Details |
| Product List |
Multiplex 6 parameters Respiratory viral fluorescent Tagman probe primers PCR reagent test kit
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-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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