Tuberculosis

TB Host Immune Response Assay (TB‑HIRA)
Research Use Only

Close up of tubercolosis under microscope

A multiplex PCR laboratory assay to detect host-response-mediated mRNA transcripts present in whole blood. For research use.

Tuberculosis - the challenge

Tuberculosis - the challenge

RISK6 explained

RISK6 explained

Simplified Workflow

Simplified Workflow

Future development

Future development

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Tuberculosis - the challenge

Tuberculosis (TB), caused by Mycobacterium tuberculosis, is the second leading cause of death by infectious disease after COVID-19 globally. The WHO estimates that in 2022 10.6 million people fell ill with TB and 1.3 million people died. Additionally, drug resistance in M. tuberculosis is an increasing problem1.

Rapid, accurate and accessible diagnostics would allow improvements for triage and treatment of patients with TB. Current diagnostic tests rely largely on potentially hard-to-obtain sputum samples or have long turnaround times. Host-response blood-based diagnostics are a current area of interest.

Doctor holding chest x-rays

RISK6 explained

TB-HIRA utilises an existing signature, RISK6 which meets the WHO target product profile performance for a TB triage test2,3.

The signature measures the relative expression of six individual mRNA transcripts in a whole blood sample. An algorithm is then applied to generate a score indicative of TB infection status2,3.

RISK6 has demonstrated potential clinical utility in monitoring the response to treatment without the need for culture, whilst also being suitable for use in children and people living with HIV3.

Close up of a person wearing a lab coat

Simplified Workflow

QuantuMDx is developing the TB-HIRA to support the global fight against the challenge of tuberculosis.

TB-HIRA comprises a single tube master-mix including all primers and reagents for quantification of transcripts measured during the RISK6 assay. This allows the relative expression of all six transcripts to be measured in a single multiplexed RT-qPCR reaction on a benchtop thermocycler.

Download our poster from the 2023 Union World Conference on Lung Health here.

Future development

QuantuMDx is working hard to develop a cassette-based TB-HIRA for the portable platform, Q-POC, so that TB diagnosis and treatment monitoring can be accessed at the Point of Need.

Hands inserting a Q-Poc Cassette in a Q-Poc machine

Technical Specifications

Contents

Assay kit:

  • TB-HIRA 1-step RT-qPCR Multiplex Assay Master Mix (1.5 ml)
  • TB-HIRA Negative control (65 μl)
  • TB-HIRA Positive control (65 μl)

Required

Instrument:

Real-time, 6-channel thermocycling instrument (e.g. ThermoFisher QuantstudioTM5)

Calibrated for the fluorphores FAM, HEX, ROX, Cy5, TAMRA and Cy5.5

RNA extraction kit: Nucleic acid extraction kit (e.g. Qiagen PAXgene® blood RNA kit, product number 762174)

Assay

Specimen type: Venous blood (2.5-3 mL in collection tubes, e.g. PaxGene® or TempusTM)

Assay Targets: FCGR1B, GBP2, SDR39U1, SERPING1, TRMT2A and TUBGCP6

Detection Method: RT-qPCR, 6 channel fluorescence detection

Run Time: Approximately 75 minutes

Temperature: Stored at –20 °C, shipped on dry ice

Storage Conditions: Store away from direct sunlight

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