Guangzhou BioKey Healthy Technology Co.Ltd
| 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 | 96 tests/kit (carton) |
| expiration date | 12 months |
| Storage | -20±5℃ |
| Applicable | Micgene 244/244 IVD(BIO-KEY) |
| Detection limit | 500 copies/mL |
| CV | ≤5% |
| Brand Name | Biokey |
| Model Number | BIK-QL-H004 |
| Certification | ISO 13485,CE |
| Place of Origin | Guangzhou China |
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Product Specification
| 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 | 96 tests/kit (carton) | expiration date | 12 months |
| Storage | -20±5℃ | Applicable | Micgene 244/244 IVD(BIO-KEY) |
| Detection limit | 500 copies/mL | CV | ≤5% |
| Brand Name | Biokey | Model Number | BIK-QL-H004 |
| Certification | ISO 13485,CE | Place of Origin | Guangzhou China |
| High Light | Human Respiratory Multiplex Real Time Pcr Kit ，Multiplex Real Time Pcr Kit Lyophilized ，Lyophilized RT QPCR Test Kit | ||
Multiplex fluorescent probe Humam Respiratory viral RT qPCR 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 |
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℃.
Data Analysis and interpretation:
The following sample results are possible::
| Ct value | Result Analysis | |
| 1# | No Ct | Negative |
| 2# | ≤38 | Positive |
| 3# | 38~40 | Re-test; if it is still 38~40, report as 2# |
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
Company Details
Business Type:
Manufacturer,Distributor/Wholesaler,Exporter,Seller
Year Established:
2003
Total Annual:
5M-10M
Employee Number:
100~200
Ecer Certification：
Verified Supplier
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. &n... 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. &n...
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