CE Mark Multiple four enteroviruses primers target Fluorescence
probing RT qPCR kit
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:
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 |
Reaction Mix preparation:
Refer to the tables below to prepare the reaction mix:
Ⅰ. Norovirus and Rotavirus reaction mix:
| 1×volume required |
| Resuspended master mix | 14 μL |
| Primer-Probe Mix 1 | 1 μL |
| Total volume | 15 μL |
Ⅱ. Adenovirus and Astrovirus reaction mix:
| 1×volume required |
| Resuspended master mix | 14 μL |
| Primer-Probe Mix 2 | 1 μL |
| Total volume | 15 μL |
※Multiply the numbers according to the number of tests.
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
