Guangzhou BioKey Healthy Technology Co.Ltd
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Multiplex RT-PCR four enteroviruses Fluorescence probing PCR test kit ( Lyophilized )
Intended use:
This kit is used for in vitro qualitative detection of Norovirus, Rotavirus, Adenovirus and Astrovirus nucleic acid RNA. It can be used for clinical auxiliary diagnosis of the etiological identification of suspected infected persons
Test Principle:
This kit uses fluorescent RT-PCR technology (TaqMan probe) to rapidly and accurately qualitatively detect the conserved regions of Norovirus/Rotavirus/Adenovirus/Astrovirus On the instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of Norovirus/Rotavirus/Adenovirus/Astrovirus through the change of fluorescent signal; the detection system contains a positive internal control (IC) gene, which is used to monitor whether the specimens and the process of nucleic acid extraction is qualified.
Product components:
The product components as following:
1. BIK-QL-H007:
| No. | Components | Amount |
| 1 | PCR Enzyme Mix (Lyophilized) | 96 tests/bottle |
| 2 |
Primer-Probe Mix 1 (Norovirus and Rotavirus) |
50 μL/vial |
| 3 |
Primer-Probe Mix 2 (Adenovirus and Astrovirus) |
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-H007S:
| No. | Components | Amount |
| 1 | 1 (Norovirus and Rotavirus Mix (Lyophilized)) | 24 tests/kit |
| 2 | 2 (Adenovirus and Astrovirus 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 |
Data anlysis:
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)Norovirus and Rotavirus reaction:
|
FAM (Norovirus) |
VIC/HEX (Rotavirus) |
ROX (IC) |
Interpretation test results | |
| 1 |
- |
- |
- |
Result invalid, test again |
| 2 | + | - | +/- | Norovirus(+) |
| 3 | - | + | +/- | Rotavirus(+) |
| 4 | + | + | +/- | Norovirus and Rotavirus(+) |
| 5 | - | - | + | Negative(-) |
(2)Adenovirus and Astrovirus reaction:
|
FAM (Adenovirus) |
VIC/HEX (Astrovirus) |
ROX (IC) |
Interpretation test results | |
| 1 |
- |
- |
- |
Result invalid, test again |
| 2 | + | - | +/- | Adenovirus(+) |
| 3 | - | + | +/- | Astrovirus(+) |
| 4 | + | + | +/- | Adenovirus and Astrovirus(+) |
| 5 | - | - | + | Negative(-) |
NOTE: ‘+ ’ is positive, ‘- ’ is negative.
Operation details please check from IFU