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Point-of-Care Diagnostic Device Clinical Trials: Registry Review

Chetan Mishra
Chetan Mishra
Oct 7, 2025

Point-of-care diagnostic devices occupy an increasingly prominent position in both clinical practice and the regulatory pipeline, with submissions to bodies such as the FDA, MHRA, and notified bodies under IVDR requiring robust clinical performance data. For regulatory affairs and clinical development teams, understanding the landscape of ongoing and recently completed trials is essential for benchmarking study designs, identifying competitive activity, and anticipating evidentiary expectations from regulators.

The analysis below surveys interventional and observational trial records filed across five major public registries—CTIS, EudraCT, the MHRA UK database, the Swiss SNCTP, and Japan's jRCT—focusing on studies in which a point-of-care or rapid diagnostic device is the primary object of evaluation. Coverage spans lateral flow assays, rapid molecular platforms, handheld analyzers, point-of-care ultrasound, and related near-patient testing modalities registered in recent years.

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Clinical trials of point-of-care diagnostic devices: a recent registry review

What the recent record shows

Point-of-care (POC) diagnostic evaluation over the last few years is dominated by infectious-disease testing, with a clear secondary cluster around antimicrobial stewardship, point-of-care ultrasound (POCUS), and chronic-disease finger-prick testing. The MHRA UK register is the richest single source of device-centric POC studies; EMA CTIS captures newer EU device-in-drug-trial protocols (sepsis biomarkers, pharmacogenomic POC tests); the Swiss and Japanese registers add respiratory and perioperative rapid-testing work. Below the findings are grouped by clinical use rather than by country.

Infectious disease: respiratory and COVID-19 rapid testing

COVID-19 drove a wave of POC and lateral-flow evaluations that remain visible across the registries.

  • Rapid community testing for COVID-19 (MHRA 4265) benchmarked several commercial antigen and molecular platforms, including the SD Biosensor Standard Q rapid antigen test, the BD Veritor system, and the LumiraDx SARS-CoV-2 and influenza A/B assay 129.
  • The LAVA 2 study (MHRA 23650) validated lateral flow antigen devices against RT-PCR in children 132.
  • SAMBA II (MHRA 32783) evaluated a point-of-care molecular device for COVID-19 in hospital patients 138, and a separate study (MHRA 935) asked whether hospital POC coronavirus testing improves patient care versus laboratory testing 142.
  • DARTS (MHRA 33944) and an earlier "Diagnostics of COVID-19" protocol (MHRA 23201) assessed point-of-need lateral flow assays for viral antigen and IgM/IgG antibodies 106107.
  • In Switzerland, RaDiCo (SNCTP HumRes52479) compared rapid diagnostic tests on saliva and nasopharyngeal swabs against PCR for SARS-CoV-2 detection 222223.
  • Beyond COVID, SIMPLIFI (MHRA 22765) tested a single-use POC device for influenza and other respiratory pathogens in the emergency department 136, and a further MHRA protocol (45956) evaluated a single-use POC device for respiratory pathogens in adults 141. The INHALE work package 3 study (MHRA 8196) compared the BioFire FilmArray Pneumonia Panel against standard testing in intensive care 145, echoed in Switzerland by EARLY ADAPT (SNCTP HumRes67123), which paired a BioFire multiplex respiratory PCR with early antibiotic de-escalation in ventilated pneumonia patients 221.
  • The Swiss ALIC4E trial (HumRes635) embedded the Idylla POC test for viral respiratory infection into a primary-care influenza-treatment study 218, and the baloxavir household transmission study (HumRes46984) used rapid influenza diagnostic tests as part of case confirmation 219.

Infectious disease: sepsis, TB, hepatitis, STIs and fungal detection

  • Sepsis is an active POC target. The EU PROMISE trial (CTIS 2025-525006-37-00) evaluates a rapid quantitative pancreatic stone protein (PSP) test on the abioSCOPE in vitro diagnostic system to guide early meropenem in the emergency department 1; the EMBRACE trial (CTIS 2024-515255-38-00) uses a point-of-care SepsisLoop measurement of the systemic inflammation index 1219; and a UK study (MHRA 24976) evaluated a rapid POC sepsis diagnostic device from Frequasense in adults presenting to A&E 134.
  • Tuberculosis: MHRA 32765 evaluated host-biomarker-based POC tests, including the TransDot finger-prick blood test, for targeted active-TB screening 130.
  • Hepatitis: ViiV Healthcare's implementation study (CTIS 2023-504993-40-00) incorporated the Determine HBsAg 2 point-of-care hepatitis B surface antigen test into HIV screening visits 5, and MHRA 34599 assessed novel microfluidic POC devices for hepatitis C detection and quantification 135.
  • Sexually transmitted infections: the Precise study (MHRA 19749) evaluated the Atlas io platform for Neisseria gonorrhoeae and Mycoplasma genitalium at the point of care with antimicrobial-resistance detection 133; related MHRA work covered adoption of a 30-minute multi-pathogen STI POC test in sexual-health clinics (20494) 143 and patient-consented sample collection for STI diagnostic and biomarker evaluation (16565) 144. Syphilis appears in the EU Trep-AB protocol (CTIS 2024-514984-24-00), which references rapid diagnostic and point-of-care tests 8.
  • Fungal disease: LFD-AsPaeds (MHRA 24612) evaluated lateral-flow devices on bronchoalveolar lavage for Aspergillus detection in immunocompromised children 150.
  • In Japan, jRCT1032230479 is evaluating the diagnostic characteristics of rapid testing for acute infectious enteritis 163, and the DOREMI trial (jRCT1040230010) is testing a novel rapid microorganism test complex to drive proactive antimicrobial strategy during pancreatoduodenectomy 166.

Antimicrobial stewardship and acute infection triage

A distinct cluster uses host-response POC biomarkers to guide antibiotic decisions.

  • ASPIRE II (MHRA 57283) evaluated a POC test combining C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) to support antibiotic stewardship in primary care 148.
  • An earlier CRP study (MHRA 2928) assessed the Afinion POC CRP analyzer for guiding antibiotic prescribing in acutely ill children 139.
  • The pan-European CA-ARTI-Dx study (MHRA 9449) evaluated POC diagnostics for respiratory-tract-infection prescribing across primary care 147.
  • DIAMONDS-SEARCH (MHRA 972) is developing rapid molecular/lab-on-chip prototypes using host-RNA gene signatures to diagnose the cause of fever, including COVID-19 149.

Point-of-care ultrasound (POCUS)

  • TenCRAOS (CTIS 2024-517606-29-00) uses bedside ocular ultrasonography in central retinal artery occlusion 98.
  • ToolCAP (SNCTP HumRes66289) applies lung POCUS to identify children with pneumonia who would benefit from antibiotics 272.
  • MHRA studies cover thoracic POCUS with intracavity ECG for central-venous-catheter placement confirmation (59425) 194 and lung ultrasound findings in COVID-19 emergency patients (48142) 201.
  • Two MHRA protocols (44199, 10337) evaluated handheld ultrasound with automated AutoDVT software (including a machine-learning comparison) for deep vein thrombosis diagnosis; the machine-learning study is recorded as stopped 197203.

Chronic disease, metabolic and micronutrient POC testing

  • HbA1c and glucose: MHRA 41899 compared the HemoCue Glucose 201 RT POC analyzer with laboratory glucose 131; MHRA 44523 used a POC HbA1c finger-prick test to screen for impaired glucose regulation 195; and MHRA 19505 evaluated POC creatinine and DCA Vantage HbA1c devices for monitoring chronic non-communicable diseases 187.
  • POET (MHRA 51174), currently recruiting, is assessing remote finger-prick POC testing (HbA1c and other routine bloods) for long-term-condition management 188.
  • Diabetic neuropathy: the EU OLT1177-12 protocol (CTIS 2024-511828-14-00) incorporates the DPNCheck and SUDOSCAN point-of-care devices alongside HbA1c and fasting glucose 87.
  • Micronutrients: the VITASCOPE studies (MHRA 58867 and 51447) evaluated a prototype POC in-vitro diagnostic for micronutrient levels using finger-prick blood and a phone app in children with obesity 152153.

Cardiovascular, coagulation and oncology POC

  • BIO-RISK-EVENT (CTIS 2024-511950-35-00) validates a point-of-care biomarker device (the PoCCardio prototype) for residual cardiovascular risk after myocardial infarction 101.
  • A Dutch stable-CAD protocol in CTIS (2023-504078-39-01) uses the Genedrive System, a point-of-care gene-amplification device, for CYP2C19 pharmacogenomic testing alongside platelet-function assays 207.
  • In Japan, jRCT1012220015 is validating early parameters of the TEG6s Platelet Mapping Assay (point-of-care viscoelastic coagulation testing) in cardiac surgery 109118.
  • Oncology POC/rapid tissue diagnostics: MHRA 58956 is testing a POC microchip system to detect bowel-cancer markers in blood and stool 151, and MHRA 37337 evaluated the iKnife (rapid evaporative ionization mass spectrometry) to distinguish normal from malignant endometrial tissue 200.
  • Wound care: the WIDE study (MHRA 31258) evaluated the Glycologic (GLYWD) POC wound-infection detection kit, including diabetic foot ulcers 146.
  • Obstetrics: the Dutch STRIDER trial (SNCTP HumRes64267) includes point-of-care assessment of low placental growth factor in early-onset intrauterine growth restriction 273.

Reading the landscape for regulatory strategy

Three practical points for RA teams tracking this space:

  1. Registry choice matters. If you are surveying device-focused POC studies, the MHRA UK database returns far more relevant records than EudraCT or CTIS, which are structured around investigational medicinal products. In CTIS, POC devices most often appear as pharmacodynamic or safety tools inside drug protocols (POC glucose in hyperinsulinism and metabolic trials, for example) rather than as the primary intervention.
  2. Infectious disease and stewardship lead. The densest recent activity is rapid respiratory/COVID testing, sepsis biomarkers (PSP, SepsisLoop, CRP/MxA), and STI and TB near-patient assays, reflecting the post-pandemic emphasis on decentralised testing and antibiotic stewardship.
  3. Emerging formats. Microfluidic and microchip platforms (HCV, colorectal markers), pharmacogenomic POC (Genedrive CYP2C19), and app-linked finger-prick IVDs (micronutrients, remote HbA1c) point to where the next round of clearances and CE marks is likely to originate.

This is a curated overview rather than a complete census. For a full, filterable list by device type, sponsor, status, or date, or for a deeper drill on any single trial (endpoints, comparators, enrolment), those follow-ups can be run directly in Rhizome.

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