Several clinical trials have been conducted in recent years (2020–2025) to evaluate point-of-care (POC) diagnostic devices across a range of clinical applications, including infectious diseases, cardiometabolic conditions, and acute care. Below is a comprehensive summary of these trials:

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1. Cardiometabolic and Chronic Disease Diagnostics

• Cardiometabolic Devices Accuracy Study (NCT05257564):

  • Objective: Evaluated the performance and usability of two POC devices (SimplexTAS 101 and Aina Station) for measuring glucose, glycated hemoglobin (HbA1c), cholesterol, and creatinine in primary healthcare (PHC) settings, particularly in low- and middle-income countries (LMICs).
  • Design: Prospective accuracy study conducted in Nepal with 400 participants.
  • Outcome: Both devices demonstrated strong correlation with laboratory standards and usability in PHC settings.
  • Timeline: Initiated in Q1 2022 and lasted four months ¹⁹²².

• POC High-Sensitivity Troponin I (hs-cTnI) Testing in Emergency Departments:

  • Objective: Assessed the Abbott i-STAT Alinity POC device for hs-cTnI testing in patients with acute coronary syndrome (ACS) in emergency departments (EDs).
  • Design: Multisite observational cohort study involving 600 patients, evaluating metrics such as time-to-result (TTR) and ED length of stay (LOS).
  • Outcome: Aimed to accelerate diagnostic and treatment decisions for ACS ¹⁴.

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2. Infectious Disease Diagnostics

COVID-19 Diagnostics

• Evaluation of Point-of-Care (EPOC) for COVID-19 (NCT05227404):

  • Objective: Investigated two POC antibody testing platforms (LumiraDX and RightSign) for detecting SARS-CoV-2 antibodies in hospitalized COVID-19 patients.
  • Design: Cross-sectional study with 375 participants across multiple sites.
  • Outcome: Assessed feasibility, reproducibility, and diagnostic accuracy compared to central laboratory assays ⁸¹⁵¹⁸.

• Q-POC SARS-CoV-2 Assay Clinical Performance Study (NCT05614011):

  • Objective: Evaluated the diagnostic performance of the Q-POC SARS-CoV-2 Assay using mid-turbinate nasal swabs, compared to the Roche Cobas 6800 SARS-CoV-2 test.
  • Outcome: Focused on metrics such as Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
  • Timeline: Planned for completion in 2024 ¹⁶¹².

• Rapid SARS-CoV-2 IgG Antibody Testing in High-Risk Healthcare Workers:

  • Objective: Used rapid POC IgG antibody tests to address testing needs during the COVID-19 pandemic, particularly for healthcare workers.
  • Technology: Lateral flow assays requiring minimal blood samples.
  • Outcome: Highlighted the potential to reduce reliance on centralized labs and improve clinical decision-making ¹¹.

Tuberculosis (TB) Diagnostics

• TB-CAPT CORE Truenat Trial (NCT04568954):

  • Objective: Evaluated the Truenat platform, a POC sputum-based test, for detecting pulmonary TB and rifampicin resistance in resource-limited settings.
  • Outcome: Aimed to align with WHO's ASSURED criteria for POC devices.
  • Timeline: Ongoing as of 2025 ¹⁷.

• TB TRIAGE+ Trial (Lesotho and South Africa):

  • Objective: Compared two TB screening approaches: CAD4TB (digital chest X-ray analysis) alone versus CAD4TB combined with a POC C-reactive protein (CRP) assay.
  • Outcome: Assessed non-inferiority and cost-effectiveness of the combined approach in detecting TB cases ¹³.

HIV Diagnostics

• Point of Care Virologic Testing for HIV (NCT02682810):
  • Objective: Tested the Alere Q POC HIV diagnostic assay to improve outcomes for HIV-infected children in resource-poor settings.
  • Outcome: Provided rapid and accessible diagnostic results ².

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3. Respiratory and Febrile Illness Diagnostics

• Evaluation of a Single-Use POC Device for Respiratory Pathogens (NCT04431050):

  • Objective: Assessed a novel single-use POC device for diagnosing influenza and other respiratory pathogens in patients with influenza-like illness (ILI).
  • Outcome: Compared the device's performance to PCR and rapid flu tests in emergency settings ⁹.

• Point-of-Care Respiratory Pathogen Testing for Antibiotic Stewardship:

  • Objective: Evaluated the impact of POC respiratory viral pathogen testing on antibiotic prescribing in primary care.
  • Design: Cluster-randomized trial with qualitative and quantitative components.
  • Outcome: Aimed to reduce diagnostic uncertainty and improve antibiotic stewardship ¹⁰.

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4. Pediatric and General Practice Diagnostics

• ePOCT for Managing Sick Children (2025):

  • Objective: Evaluated second-generation electronic POC tests (ePOCT) incorporating pulse oximetry, hemoglobin testing, and inflammatory biomarkers (e.g., CRP) to guide antibiotic use in sick children.
  • Outcome: Previous trials in Tanzania showed improved clinical cure rates and reduced antibiotic prescriptions; the ongoing trial in Rwanda seeks to validate these findings ²⁵.

• POC PCR Diagnostics for Respiratory Tract Infections (2023):

  • Objective: Assessed the impact of POC PCR diagnostics for respiratory tract infections in general practice in Denmark.
  • Outcome: Aimed to improve diagnostic accuracy, reduce unnecessary antibiotic prescriptions, and decrease patient re-contacts ²⁴.

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5. Other Applications

• Click Diagnostics' POC Device for STIs (2022):

  • Objective: Evaluated a single-use, disposable POC device for detecting sexually transmitted infections (STIs) in women using miniaturized PCR technology.
  • Outcome: Enabled same-visit diagnosis and treatment, reducing delays associated with traditional lab testing ²³.

• Clinical Impact of Rapid Molecular Testing for Pneumonia Pathogens:

  • Objective: Evaluated the BIOFIRE® FILMARRAY® Pneumonia Panel Plus for detecting bacterial and viral pneumonia pathogens in elderly patients with severe acute respiratory illness.
  • Outcome: Demonstrated high sensitivity and specificity, with rapid results in about one hour ²¹.

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Conclusion

These trials highlight the diverse applications of POC diagnostic devices, including cardiometabolic diseases, infectious diseases (e.g., COVID-19, TB, HIV, STIs), respiratory illnesses, and pediatric care. They emphasize the potential of POC diagnostics to improve healthcare outcomes by enabling rapid, accurate, and accessible testing in both resource-limited and high-resource settings.

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