Product Details:
|
Specimen: | Nasal / Throat Swab | Expiration Date: | 12 Months |
---|---|---|---|
Logistic Condition: | Room Temperature | Applicable: | Micgene 244/244 IVD(BIO-KEY) |
Limited Of Detection: | 500 Copies/mL | CV: | ≤5% |
Component: | RT-PCR Enzyme Mix, Primers And Probes | Packing: | Freeze Dried Powder Lyophilization |
High Light: | CE SARS-CoV-2 Respiratory PCR Test kit,Respiratory PCR Test kit Freeze Dried Powder,CE PCR Influenza Ab Test Kit |
CE approved Combo Respiratory virus SARS-CoV-2 / Influenza A+B PCR Test Freeze Dried Powder
Intended use:
Test Principle:
Product components:
No | Components | BIK-QL-H010 | BIK-QL-H010S |
1 |
PCR Enzyme Mix (Lyophilized) |
96 tests/bottle | 48 tests/kit |
2 | Primer-Probe Mix | 100 μL/vial | / |
3 | Enzyme Mix Buffer (5×) | 400 μL/vial | / |
4 | Positive Control | 100 μL/tube | 100 μL/tube |
5 | Negative Control | 100 μL/tube | 100 μL/tube |
6 | RNase-free water | 1mL/tube | 1mL/tube |
7 | Paraffin oil | 1.5mL/tube*2 | 1.5mL/tube |
Storage and stability:
Specimen requirements:
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:
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 ,Influ enza A(+) |
6 | + |
- |
+ | +/- |
SARS-CoV-2 ,Influ enza B(+) |
7 | - | + | + | +/- | Influenza A+B(+) |
8 | + | + | + | +/- |
SARS-CoV-2 ,Influ enza A+B(+) |
9 | - | - | - | + | Negative(-) |
NOTE: ‘+ ’ is positive, ‘- ’ is negative.
Operation details please check from IFU!
Contact Person: Tracy
Tel: +8618802073256