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96 Tests/Kit Trichomonas Vaginalis TV RT PCR Detection Kit Operation Manual

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96 Tests/Kit Trichomonas Vaginalis TV RT PCR Detection Kit Operation Manual

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Brand Name : Biokey

Model Number : BIK-QL-H0020

Certification : CE

Place of Origin : Guangzhou China

MOQ : We can produce liquid and lyophilized kits

Price : USD

Payment Terms : L/C, T/T, Western Union

Supply Ability : 100,000 per day

Delivery Time : Depending on order quantity

Packaging Details : Carton package

Package : 96 tests/kit

expiration date : 12 months

Storage : -20±5℃

Applicable : Micgene 244/244 IVD(BIO-KEY)

LoD : 1000 copies/mL

CV : ≤5%

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Trichomonas vaginalis (TV) RT-PCR Detection Kit (Lyophilized) Operation Manual
--96 tests/kit


Intended use:

By using real time PCR systems, Trichomonas vaginalis (TV) real time PCR kit is used for the in vitro qualitative detection of TV. It can be used for the laboratory diagnosis and monitoring of TV infection. The test results are only for clinical reference, not for case confirmation or exclusion.

Principle:

The specific primers and specific fluorescent probes are designed for the nucleic acid conserved region of Trichomonas vaginalis (TV). 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 TV 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.



Main components:

No. Components BIK-QL-H0020

1

PCR Enzyme Mix(Lyophilized)

96 tests/bottle

2 TV Primer-Probe Mix 100 μL/vial
3 Enzyme Mix Buffer (5×) 400 μL/vial
4 Positive Control 100 μL/tube
5 Negative Control 100 μL/tube
6 RNase-free water 1mL/tube
7 Paraffin oil 1.5mL/tube*2

Note: Do not mix the components from different batches for detection. The Positive Control of TV and internal control were constructed artificially, and they were not infectious.

Specimen requirements:

1. Specimen type

Urine or female vaginal secretions swab samples.

2. Specimen Preservation

The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃

PCR Amplification condition:


PCR amplification according to the following procedures:

Step Cycle number Temperature Time
1 1 95℃ 3min
2 40 95℃ 10s
60℃ 30s collect fluorescent

Instrument detection channel selection: FAM and HEX/VIC.

Quality control:

Ct value
Negative Control No Ct
Positive Control ≤30
IC of samples ≤38


Note: Negative Control, Positive Control and IC of samples must be performed correctly, otherwise the sample results is invalid.

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#


Operation details please check from IFU!


Product Tags:

CE RT PCR Detection Kit

      

Trichomonas Vaginalis PCR Detection Kit

      

RT PCR Detection Kit Lyophilized

      
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