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CE-IVDR · ISO 13485 · FDA 510(k) cleared

The answer your clinician needs, before the shift changes.

DiagnostiQ builds cartridge-based in-vitro diagnostic systems for hospital laboratories — a single analyser, six assay families and one result pipeline that hands a validated, LIS-ready answer to the ward in under twenty minutes.

17 minMedian TAT
220+Hospital labs
41Countries
Q-Core 200 · Running Technicians at work in a hospital clinical diagnostics laboratory lined with analysers

Last 24 h panel pass rateLive

Q-Sepsis99.4%
Q-Respi98.9%
Q-Cardio99.8%
CE-IVDRISO 13485:2016FDA 510(k)CLIA High ComplexityWHO PrequalifiedISO 15189 AlignedIVDR Class CUKCA MarkedTGA Registered
01Diagnostic products
Assay menu

Six panels. One cartridge format. Every shift covered.

Each panel ships as a room-temperature, sealed single-use cartridge with on-board controls — no reagent preparation, no cold chain, no open-tube handling between sample and result.

BC-240 Rows of colour-capped blood collection tubes in a laboratory rack

Q-Sepsis™ Blood Culture Panel

Rapid identification of the 26 most common bloodstream pathogens with direct mecA and vanA/vanB resistance calls from positive culture bottles.

26 targetsAMR markers3.5 h
Sepsis / ICUSpec sheet
RP-22 Gloved hand holding a sealed clinical sample tube

Q-Respi™ 22-Target RT-PCR

Influenza A/B, RSV, SARS-CoV-2, hMPV and eighteen seasonal coronaviruses and adenoviruses in a single closed-tube amplification.

22 targetsInternal control48 min
RespiratorySpec sheet
CT-01 Sample tubes loaded onto a clinical laboratory analyser carousel

Q-Cardio™ hs-Troponin I

High-sensitivity troponin I for chest-pain pathways, with a 12-minute first result and serial sampling built into a single cartridge.

LoD 1.2 ng/L12 minWhole blood
EmergencySpec sheet
HB-09 Rack of capped laboratory tubes lined up in a tray

Q-Metab™ HbA1c & Lipid Cartridge

HbA1c, total cholesterol, HDL, LDL and triglycerides from one capillary or venous draw — built for diabetes and cardiovascular clinics.

5 analytesIFCC aligned9 min
Chronic careSpec sheet
AU-48 Scientist pipetting samples into a multi-well assay plate

Q-Immune™ Autoimmune Multiplex

Forty-eight autoantibody targets — ANA, ENA, anti-CCP, ANCA and coeliac serology — read in one multiplexed run from a single serum sample.

48 targetsSerum / plasma75 min
ImmunologySpec sheet
LB-12 Illustration of a white and blue DNA double helix against a dark background

Q-Onco™ ctDNA Liquid Biopsy

Twelve guideline-relevant somatic variants called from circulating tumour DNA in plasma, with a 0.05% variant allele detection floor.

12 variantsVAF 0.05%Plasma
OncologySpec sheet
02Technology platform
Q-Core™ architecture

Three movements of a sample, and none of them are manual.

Q-Core is our closed-cartridge platform: a lyse-and-capture front end, a six-channel fluorescence back end and a reporting layer that speaks the language your laboratory information system already understands.

Q-Core style benchtop clinical analyser with an integrated display in a laboratory
Q-Core 200Benchtop · 0.62 m² footprint · 480 tests/hour
01

Load & lyse

The cartridge is seated in the dock and the sample is drawn in through a sealed microfluidic channel. Lysis, nucleic-acid capture and reagent rehydration all happen on-board, so nothing is pipetted by hand.

  • Single-use cartridge, no cold chain
  • On-board positive and negative controls
  • Barcoded sample-to-cartridge traceability
02

Amplify & read

Thermal cycling runs in the cartridge while six fluorescence channels read each well in parallel. Signal processing flags inhibition, contamination and borderline calls before anything reaches a report.

  • 6-channel optics, 34-reportable-target capacity
  • Automatic Ct statistics and inhibition flags
  • Per-run Levey-Jennings QC charts
03

Report & integrate

Results are released to the analyst console and pushed into the hospital record the moment they are authorised — HL7 v2.5, ASTM and FHIR R4 interfaces ship in the box, not as an add-on licence.

  • HL7 v2.5 / ASTM / FHIR R4 out of the box
  • Bi-directional order download from the LIS
  • Versioned audit trail for ISO 15189 review

Platform specification

480Tests / hour
17 minMedian TAT
0.62 m²Bench footprint
3.5 hCartridge to result, walk-away
03Analytical accuracy
Verified performance

Numbers a laboratory director can sign off on.

Performance below comes from a nine-site method-comparison study run on prospective clinical samples, with sensitivity and specificity measured against a composite reference standard rather than against our own earlier kit.

0%Clinical sensitivity

Across 12,480 prospective samples, all nine sites pooled.

0%Specificity

Composite reference standard, equivocal results excluded.

0minMedian turnaround

Specimen receipt to authorised result, routine daytime load.

0Countries deployed

220+ hospital and reference laboratories running Q-Core.

Q-Core 200 versus a reference laboratory method

DiagnostiQ Study DX-1140 · 2025 Scroll the table to compare →
MetricDiagnostiQ Q-Core 200Reference method
Clinical sensitivity99.4%96.1%
Clinical specificity99.8%98.4%
Limit of detection12 copies/mL45 copies/mL
Median turnaround time17 min4.2 h
Operator hands-on time4 min38 min
Repeatability (CV)0.4%1.9%
Reportable genotypes / targets3412

DiagnostiQ internal method-comparison study DX-1140 (n = 12,480 prospective clinical specimens; nine hospital sites; 2024–2025). Sensitivity and specificity are calculated against a composite reference standard of culture plus sequencing. Limit of detection determined by probit analysis at 95% detection probability. Figures describe the Q-Core 200 with current cartridge revisions and are provided for evaluation purposes only — they are not a guarantee of performance in any individual laboratory. Local validation against your own population remains the responsibility of the testing laboratory.

04Hospital partnerships
Clinical network

Already running the night shift in 220 laboratories.

From single-site district hospitals to national reference networks, Q-Core installations are supported by DiagnostiQ field engineers and a validated training programme for laboratory staff.

St. Anne's
Medical Centre
Northgate
Health Trust
City General
Hospital
Mercy Valley
Regional Lab
Harbour Clinical
Group
Westport University
Hospital

We replaced a send-out pathway that took two days with a 17-minute in-house result. Sepsis escalation decisions at 3 a.m. are now made on a number, not on a hunch — that changed our antibiotic stewardship numbers measurably within two quarters.

Dr Daniel Mwangi Dr Daniel MwangiClinical Microbiology Lead, City General Hospital

The cartridge format is what sold the laboratory committee. No reagent prep, no cold chain, and the QC data lands in the audit trail without anyone typing it in. Revalidation after a cartridge revision was a morning's work, not a project.

Dr Wei-Lun Chen Dr Wei-Lun ChenDirector of Laboratory Medicine, Westport University Hospital

Rolling Q-Core across six sites took eleven weeks including training. Their engineers were on-site for every go-live, and the HL7 interface to our record system worked on the first attempt — which, in my experience, is close to unheard of.

Sofia Renner Sofia RennerChief Operating Officer, Northgate Health Trust
220+Hospital laboratories
41Countries live
9Reference sites in study DX-1140
48 hEngineer response SLA
05 — Distribution

Bring Q-Core to your territory.

We appoint one exclusive distributor per territory and support them properly: demo units, technical training, regulatory dossiers and a co-funded launch. If you already sell to hospital laboratories, we would like to talk.

  • Up to 42% list margin on cartridges, with volume tiers reviewed annually and a protected territory written into the agreement.
  • A demo Q-Core 200 and starter cartridge set on consignment, so your team can run live evaluations in a customer's laboratory.
  • Three-day engineer certification at our facility or yours, plus recertification as cartridge revisions are released.
  • Regulatory and tender support — CE-IVDR and 510(k) dossiers, local registration documentation and multilingual clinical evidence packs.
  • 48-hour technical response from a named regional engineer, with spare-part stock held in Singapore and Rotterdam.
Open: Southeast Asia Open: GCC Open: LATAM Open: Eastern Europe Appointed: Western Europe

Distributor enquiry

Tell us your territory and we will send the full distributor pack, assay menu and pricing schedule within two working days.

By submitting you agree to be contacted about distribution of DiagnostiQ products. We do not share enquiry data with third parties.

Thank you — your enquiry is logged. Our distribution team will reply within two working days.