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Product Details:
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| Package: | 48 Tests/kit | Expiration Date: | 12 Months |
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| Storage: | -20±5℃ | Applicable: | Micgene 244/244 IVD（BIO-KEY） |
| LoD: | 1000 Copies/mL. | CV: | ≤5% |
| High Light: | Influenza B RT PCR Test Kit,Lyophilized RT PCR Test Kit,Syncytial Virus Respiratory PCR Test |
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Respiratory Syncytial Virus/Influenza B/Influenza A RT-PCR test kit (Lyophilized) --48 tests/kit
Intended use:
This kit is used for in vitro qualitative detection of RSV/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
Principle:
The kit adopt TaqMan fluorescent probe method. For the highly conserved and specific region of RSV/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 PCR instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of RSV/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.
Main components:
| No. | Components |
BIK-QL-H0016S |
|
1 |
PCR Enzyme Mix (Lyophilized) |
48 tests/kit |
| 2 | Positive Control | 100 μL/tube |
| 3 | Negative Control | 100 μL/tube |
| 4 |
RNase-free water |
1mL/tube |
| 5 |
Paraffin oil |
1.5mL/tube |
Note: Do not mix the components from different batches for detection. The Positive Control of RSV/Influenza A+B and internal control were constructed artificially, and they were not infectious.
Product lyophilization package:
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:
|
FAM(RSV) |
VIC/HEX(Influenza A) |
ROX(Influenza B) |
CY5(IC) |
Interpretation test results |
|
|
1 |
- |
- |
- |
- |
Result invalid,test again |
|
2 |
+ |
- |
- |
+/- |
RSV (+) |
| 3 | - | + | - | +/- | Influenza A(+) |
| 4 | - | - | + | +/- | Influenza B(+) |
|
5 |
+ |
+ |
- |
+/- |
RSV ,Influenza A(+) |
|
6 |
+ |
- |
+ |
+/- |
RSV ,Influenza B(+) |
| 7 | - | + | + | +/- | Influenza A+B(+) |
|
8 |
+ |
+ |
+ |
+/- |
RSV ,Influenza A+B(+) |
| 9 | - | - | - | + | Negative(-) |
NOTE: ‘+’ is positive, ‘-’ is negative.
Operation details please check from IFU!
Contact Person: Ms. Lisa
