SARS-CoV-2 détection PCR Kit

Human health

SARS-CoV-2 detection PCR Kit

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Complete kit includes: RT-qPCR master mix (including internal control : primers and probe specific to the human RNase P gene) A positive control (inactivated SARS-CoV-2 RNA) A negative control (RNA from a qualified human cell line without the presence of SARS-CoV-2) The controls are used to validate the extraction steps, RT (Reverse transcriptase) and PCR steps Reliable, clear and accurate results thanks to included controls and absence of background noise Validated PCR instruments LineGene 9600 Plus (BIOER), CFX96 Touch™ (Bio-Rad) Required detection channels 4 fluorescence channels: FAM (ORF1ab gene), HEX (N gene), Cy5 (RNase P) Extraction method MTL, Magnetic bead extraction CE-IVDD certification

Indication

In vitro diagnostic medical device for professional use in medical laboratories staffed by qualified personnel.

Principle

Genomic detection Real-time PCR

Withdrawal

Nasopharyngeal, Salivary

Target sequences

ORF1ab and N genes (SARS-Cov-2); RNase P gene (endogenous control)

Detection Limit (LoD)

ORF1ab gene: Nasopharyngeal= 50 copies/reaction; Salivary= 100 copies/reaction; N gene: Nasopharyngeal=10 copies/reaction; Salivary= 50 copies/reaction

Specific

Nasopharyngeal=100%; Salivary= 99%.

Sensitivity

Nasopharyngeal=100%; Salivary= 100%.

Storage (t°C)

-25°C/-15°C

Catalog number

KSC2AB69

Packaging

96 tests

Manufacturer

Appolon Bioteck

Country

France

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If you have any questions or would like to discuss our services, we invite you to contact us. Our team is always available to assist you, 7 days a week, and is committed to responding to all your requests in less than 24 hours.

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Any questions?

At SARS-CoV-2 detection PCR Kit, we understand the regulatory challenges faced by our French customers. We offer support in your accreditation process, including assistance in preparing the files needed to validate new techniques. Our approach is to provide local support, with flexibility and adaptability.

We are ISO 13485:2016 certified, demonstrating our commitment to the highest international standards for medical devices. What’s more, all our products are designed and manufactured in France, guaranteeing a high level of expertise and quality control.

We maintain a strategic buffer stock for all our distributed products, minimizing the risk of stock-outs. Should the need arise, our Lyon-based after-sales service is ready to react quickly to ensure your business continues uninterrupted.

Our logistics are optimized for rapid delivery throughout France and internationally. With efficient processes and a well-established distribution network, we ensure that your orders reach you in the shortest possible time.

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  • 205, rue des frères Lumière 69970 CHAPONNAY
    France
  • +33 (0)4 37 57 00 54
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