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Product Details:
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| Package: | 96 T/kit (carton) / 48 T/kit (single Tube) | Specimen: | Human Throat Swabs, Herpes Fluid Samples, Stool Samples, And Anal Swab Samples. |
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| Specimen Preservation: | Be Stored For 3 Months At -20±5℃ And For A Long Time Below -70℃ | Applicable: | Micgene 244/244 IVD(BIO-KEY) |
| Detection Limit: | 500 Copies/mL | CV: | ≤5% |
| High Light: | Lyophilized Digestive Test Kit ISO,Digestive Test Kit EV71 ISO,Fast NAT EV71 RT Test Kit |
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Fast Amplification PCR Test Kit Enterovirus 71 (EV71) RT-PCR Detection Kit (Lyophilized)
Intended use:
By using real time PCR systems, Enterovirus 71 real time PCR kit is used for the in vitro qualitative detection of Enterovirus 7. It can be used for the laboratory diagnosis and monitoring of the EV71 infection, which often causes hand-foot and mouth disease (HFMD). The test results are only for clinical reference, not for case confirmation or exclusion.
Test Principle:
The specific primers and specific fluorescent probes are designed for the nucleic acid conserved region of EV71. The RT-PCR reaction solution and real-time fluorescent quantitative PCR detection technology is applied on the fluorescence quantitative PCR instrument for realizes the rapid detection of EV71 through the change of fluorescence signal. The detection system contains a human internal control (IC) gene, which is used to monitor whether the specimens and the process of nucleic acid extraction is qualified.
Product components:
| No. | Components | BIK-QL-H003 | BIK-QL-H003S |
| 1 |
PCR Enzyme Mix (Lyophilized) |
96 tests/bottle | 48 tests/kit |
| 2 | EV71 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 |
Note: Do not mix the components from different batches for detection. The Positive Control of EV71 and internal control were constructed artificially, and they were not infectious.
Compatible instruments:
The diagnostic kit is applicable to PCR instrument with multi-color fluorescence channel FAM,VIC/HEX and ROX, including Quant Studio5 (ABI), Micgene 244/244 IVD(BIO-KEY).
Reaction Mix Preparation:
Refer to one of the table below to prepare the reaction mix:
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1×volume required |
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| Resuspended master mix | 14 μL |
| EV71 Primer & probe | 1 μL |
| Total volume | 15 μL |
※Multiply the numbers according to the number of tests.
PCR amplification condition:
PCR amplification according to the following procedure:
| Step | Cycle | Temperature | Time |
| 1 | 1 | 50℃ | 10 min |
| 2 | 1 | 94℃ | 3 min |
|
3 |
40 |
94℃ | 10 s |
| 60℃ |
30 s (Collection of fluorescence) |
Select the detection channels as following:
a) Select FAM channels to detect EV71.
b) Select HEX/VIC channel to detect internal control.
Reaction Mix Preparation:
Refer to one of the table below to prepare the reaction mix:
| 1×volume required | |
| Resuspended master mix | 14 μL |
| EV71 Primer & probe | 1 μL |
| Total volume | 15 μL |
※Multiply the numbers according to the number of tests.
Product picture:
Operation details please check from IFU
Contact Person: Ms. Lisa
