COVIDtect Multiplex RT-PCR Kit

Product Overview


As SARS-CoV-2 continues to evolve, variants such as Omicron demonstrate increased transmissibility and altered clinical profiles. Symptoms range from asymptomatic carriage to severe pneumonia, ARDS, sepsis, and death, with the elderly and those with pre-existing conditions at greatest risk. Accurate, rapid detection remains critical not only for individual patient management but also for variant surveillance and public health decision-making. Single-gene assays risk variant-related detection failures, underscoring the need for a multi-target approach.

The COVIDtect Multiplex RT-PCR Kit from Genes2Me delivers precise detection of SARS-CoV-2 across all major variants in a single assay. By targeting three viral genes simultaneously and enabling Omicron differentiation via S gene dropout, it provides comprehensive, variant-aware results directly from nasopharyngeal and oropharyngeal swabs.

Targets:
SARS-CoV-2 (RdRp, N, S genes) incl. Omicron differentiation
Technology:
Multiplex Real-Time RT-PCR
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Nasopharyngeal & Oropharyngeal Swabs
Certification:
CE-IVD
COVIDtect

Genes2Me is a CE Marked molecular diagnostics company trusted by clinical laboratories across global markets. The COVIDtect Multiplex RT-PCR Kit meets European conformity standards for in vitro diagnostic devices, validated to international benchmarks for accuracy, reliability, and safety

How the Assay Works


The COVIDtect kit uses multiplex real-time reverse-transcription PCR to simultaneously target three SARS-CoV-2 genomic regions: the RdRp gene, the N gene, and the S gene. S gene dropout in the context of a positive result indicates the presence of the Omicron variant. Human RNaseP serves as an internal control, monitoring PCR inhibition and validating extraction and amplification in every run. A complete reagent set including positive control template is supplied, supporting a seamless and contamination-free workflow.

Why Multiplex Testing Matters


As SARS-CoV-2 continues to mutate, single-gene assays are increasingly vulnerable to variant-related detection gaps. Targeting three genes simultaneously ensures that no single mutation can cause a missed positive, while S gene dropout provides actionable variant-level information without the need for separate sequencing. A built-in internal control further guards against false negatives from PCR inhibition, delivering results that clinicians and public health teams can act on with confidence.

Sample Type & Reporting Output


Sample Type:
Nasopharyngeal and oropharyngeal swab samples
Reporting Output:
Qualitative detection of SARS-CoV-2 (Detected / Not Detected) with Omicron differentiation
Targets Detected:
RdRp gene, N gene, S gene of SARS-CoV-2

Key Features & Benefits


Three-gene multiplex targeting for comprehensive detection

Targets RdRp, N, and S genes of SARS-CoV-2 simultaneously, ensuring high specificity, sensitivity, and the ability to differentiate the Omicron variant via S gene dropout.

Omicron variant differentiation

S gene dropout pattern enables identification of Omicron alongside other SARS-CoV-2 variants, supporting variant-aware clinical and epidemiological decision-making.

RNaseP internal control in every run

Monitors PCR inhibition and validates extraction and amplification, minimising the risk of false-negative results across all samples.

All reagents included

Primer and probe mixes, OneStep qRT-PCR master mix, positive control template, and RNase/DNase-free water are all supplied for a seamless, contamination-free workflow.

Compatible with multiple leading PCR platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480.

Rapid results with reliable low viral load detection

Results available within hours, with a Ct cut-off of 35 or below ensuring robust detection even in samples with low SARS-CoV-2 viral loads.

Applications


  • Clinical & Hospital Laboratories: Enables rapid, sensitive detection and variant differentiation of SARS-CoV-2, supporting timely patient management, isolation decisions, and infection control protocols.
  • Paediatric & Neonatal Care: Supports early identification in younger patients where COVID-19 presentations may be atypical, ensuring appropriate clinical pathways are initiated without delay.
  • Outbreak Surveillance: Three-gene targeting with Omicron differentiation makes this an effective tool for real-time variant monitoring and containment in hospital and community settings.
  • Immunocompromised Patients: Essential for transplant recipients, oncology patients, and those on immunosuppressive therapy, where SARS-CoV-2 infection carries a significantly elevated risk of severe outcomes.
  • Travel & Occupational Health: Reliable, comprehensive SARS-CoV-2 testing for international travel clinics and occupational health programmes, with variant-level insight to support public health reporting.

Analytical Performance


  • High analytical sensitivity and specificity across all three viral gene targets
  • Ct cut-off of 35 or below for positive detection, reliable even in samples with low viral loads
  • Omicron variant differentiation via S gene dropout, without the need for additional sequencing
  • RNaseP internal control monitors PCR inhibition and prevents false-negative results
  • Positive control template included for full assay integrity validation

Ordering Information


Commercial Name Old Cat No. New Cat No. Pack Size
COVIDtect Multiplex RT-PCR Kit G2M030321R 50 Tests

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.


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