Vector Borne Transmission Disease

Product Overview


Malaria remains one of the most widespread infectious diseases globally, affecting millions annually across tropical and subtropical regions. Despite progress in global control programmes, drug-resistant Plasmodium parasites and insecticide-resistant mosquitoes continue to make timely, accurate diagnosis a critical clinical need. Traditional frontline tools have significant limitations: microscopy demands skilled expertise and misses low parasite densities, while rapid diagnostic tests show variable accuracy and produce false negatives in low-transmission settings.

The Malaria-Q Real-Time PCR Kit from Genes2Me delivers molecular-grade precision for malaria detection. Targeting conserved regions of the Plasmodium genome using advanced primer-probe chemistry, it detects parasite DNA directly from whole blood, serum, or plasma with sensitivity that exceeds both microscopy and RDTs, enabling confident diagnosis even at low parasite loads.

Targets:
Plasmodium species (Malaria parasite DNA)
Technology:
TaqMan-based Real-Time PCR
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Whole Blood, Serum, Plasma
Certification:
CE-IVD
Denfue-Q

Genes2Me is a CE Marked molecular diagnostics company trusted by clinical laboratories across global markets. The Malaria-Q Real-Time 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 Malaria-Q kit uses TaqMan-based real-time PCR with primer-probe chemistry labelled with HEX to amplify conserved regions of the Plasmodium parasite genome. A built-in internal control monitored on the Cy5 channel validates DNA extraction and amplification in every reaction, guarding against false negatives caused by inhibition or poor sample quality. No-template and positive controls are included to confirm reagent performance and contamination-free processing across all runs.

Why Real-Time PCR Matters for Malaria


Microscopy and RDTs remain widely used but carry well-documented limitations in low-density parasitaemia, mixed infections, and drug-resistant strains where antigen expression may be reduced. Real-time PCR is the gold standard for malaria detection because it targets parasite DNA directly, is unaffected by antigen variation, and detects infections below the threshold of visual or immunochromatographic methods. The built-in internal control in the Malaria-Q kit adds an additional layer of assurance, ensuring every negative result is a true negative.

Sample Type & Reporting Output


Sample Type:
Whole blood, serum, and plasma
Reporting Output:
Qualitative detection of Plasmodium parasite DNA (Detected / Not Detected)
Targets Detected:
Conserved genomic regions of Plasmodium species

Key Features & Benefits


High sensitivity detection at low parasite densities

With a limit of detection of 500 copies/ml and 100% analytical sensitivity, the kit reliably identifies malaria infections even when parasite loads are too low for microscopy or RDTs to detect.

Built-in internal control for every run

The Cy5 internal control validates DNA extraction and amplification in every reaction, minimising the risk of false negatives and ensuring result integrity across all sample types.

Ready-to-use reagent system

Pre-formulated reagents with a 12-month shelf life, shipped and stored under controlled cold chain conditions, support a streamlined and contamination-free workflow.

Strict NTC and PC validation

No-template and positive controls are included in every kit, eliminating contamination risks and confirming consistent reagent performance across runs.

High reproducibility

Coefficient of variation below 2.5% across all runs ensures consistent, trustworthy results that laboratories and clinicians can rely on.

Compatible with multiple leading PCR platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480, supporting seamless integration into existing laboratory workflows.

Applications


  • Clinical & Hospital Laboratories: Enables accurate detection of malaria parasites from blood, serum, or plasma with sensitivity exceeding microscopy and RDTs, supporting timely treatment and reducing misdiagnosis risk.
  • Paediatric & Neonatal Care: Critical early detection tool for young children in endemic regions, where low parasite density infections are common and severe complications including cerebral malaria can develop rapidly.
  • Outbreak Surveillance: Supports real-time monitoring of malaria transmission in endemic and epidemic settings, enabling targeted public health responses and assessment of drug-resistant parasite spread.
  • Immunocompromised Patients: Essential for HIV-positive individuals, transplant recipients, and others with impaired immunity, where low-density parasitaemia may be missed by conventional methods but can still cause severe illness.
  • Travel & Occupational Health: Reliable malaria detection for international travel clinics and occupational health programmes serving individuals returning from or working in malaria-endemic regions.

Analytical Performance


  • 100% analytical sensitivity and 99% clinical specificity
  • Limit of detection: 500 copies/ml, enabling detection at low parasite densities
  • High reproducibility with coefficient of variation below 2.5%
  • Cy5 internal control validates DNA extraction and amplification in every reaction
  • NTC and positive controls included for full assay integrity validation

Ordering Information


Commercial Name Old Cat No. New Cat No. Pack Size
Malaria-Q Real-Time PCR Kit G610002-1 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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