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opencc-by-4.0Aug 2017View details →

Evaluation of two 4th generation point-of-care assays for the detection of Human Immunodeficiency Virus infection.

Background. Fourth generation assays detect simultaneously antibodies for HIV and the p24 antigen, identifying HIV infection earlier than previous generation tests. Previous studies have shown that the Alere Determine HIV-1/2 Combo has lower than anticipated performance in detecting antibodies for HIV and the p24 antigen. Furthermore, there are currently very few studies evaluating the performance of Standard Diagnostics BIOLINE HIV Ag/Ab Combo. Objective: To evaluate the performance of the Alere Determine HIV-1/2 Combo and the Standard Diagnostics BIOLINE HIV Ag/Ab Combo in a panel of frozen serum samples. Study Design: The testing panel included 133 previously frozen serum specimens from the UCLA Clinical Microbiology & Immunoserology laboratory. Reference testing included testing for HIV antibodies by a 3rd generation enzyme immunoassay followed by HIV RNA detection. Antibody negative and RNA positive sera were also tested by a laboratory 4th generation HIV Ab/Ag enzyme immunoassay. Results: Reference testing yielded 97 positives for HIV infection and 36 negative samples. Sensitivity of the Alere test was 95% (88-98%), while the SD Bioline sensitivity was 91% (83-96%). Both assays showed 100% (90-100%) specificity. No indeterminate or invalid results were recorded. Among 13 samples with acute infection (HIV RNA positive, HIV antibody negative), 12 were found positive by the first assay and 8 by the second. The antigen component of the Alere assay detected 10 acute samples, while the SD Bioline assay detected only one. Conclusions: Both rapid assays showed very good overall performance in detecting HIV infection in frozen serum samples, but further improvements are required to improve the performance in acute infection.

opencc-by-4.0May 2022View details →

Point-of-care monitoring of head and neck cancer treatment response and recurrence development using nanopore-based ctDNA consensus sequencing

Circulating tumor DNA (ctDNA) in blood may become a generic biomarker for non-invasive cancer diagnosis and monitoring. However, detection of ctDNA is challenged by the presence of many circulating DNA molecules from healthy cells. We found that single ctDNA molecules can be sequenced with high accuracy by a three-step process consisting of capturing, copying and concatenation of the original double-stranded ctDNA molecules. This innovative approach - called CyclomicsSeq -  is unparalleled by any other method in terms of cost-efficiency and speed, allowing point-of-care cancer diagnostics. Within this CPOC, subsidized by the Oncode institute, we have applied our CyclomicsSeq ctDNA test in patients with advanced head and neck cancer squamous cell carcinoma (HNSCC). Head and neck cancer (HNSCC) accounts for 380,000 cancer-related deaths worldwide. For these patients, determining whether a patient responds to the primary chemoradiation treatment is challenging, and non-responders are sometimes identified when other treatment options are no longer possible. By measuring the ctDNA levels in the blood of these patients prior to and during treatment, we aim to identify non-responders at an earlier stage. This dataset contains base calls of TP53 of 47 nanopore sequencing runs. We included 10 patients and 7 controls. For the patients, we have samples of multiple time points (0 = prior to treatment, 1 = 1 week after treatment initiation, etc).

Figure 5 in Improved diagnostic sensitivity of human strongyloidiasis using point-of-care mixed recombinant antigen-based immunochromatography

Figure 5. The intensity values of NIE (a), SsIR (b), and NIE-SsIR (c) ICT kits were evaluated using an in-house strip reader (red line indicates cut-off intensity value). Groups I, II, and III represented healthy controls, proven strongyloidiasis, and other parasitic infections, respectively. Any value above the cut-off value (red horizontal lines) is negative. Receiver operator characteristic (ROC) area analyses of the NIE, SsIR, and NIE-SsIR ICT kits to compare accuracy of all kits with gold standard methods (d).

Figure 3 in Improved diagnostic sensitivity of human strongyloidiasis using point-of-care mixed recombinant antigen-based immunochromatography

Figure 3. The purified NIE (a) and SsIR (b) fusion-tagged proteins visualized following electrophoresis through 12% and 10% SDS–PAGE, respectively. The gels were stained with Coomassie Brilliant Blue. Representative dot ELISAs (c) using NIE (1–2), SsIR (3–4), and mixed NIE and SsIR (5–6) proteins as the antigens probed with pooled positive (1, 3, 5) and negative (2, 4, 6) sera. M indicates molecular mass maker.

Figure 1 in Improved diagnostic sensitivity of human strongyloidiasis using point-of-care mixed recombinant antigen-based immunochromatography

Figure 1. Flow diagram of study design for the NIE, SsIR, and NIE-SsIR ICT kits. The SsIR ICT kit procedure was performed as previously described by Boonroumkaew et al. [4].

Figure 2 in Improved diagnostic sensitivity of human strongyloidiasis using point-of-care mixed recombinant antigen-based immunochromatography

Figure 2. The parts of an ICT kit (left) and reference colour card (right) (a). An ICT kit showing a positive result (b) with a band at both control (C) and test (T) lines. An ICT kit showing a negative result (c) with a band only at the C line. The intensity value of the colour image is specified by the red, green, and blue parameters as separate integers from 0 to 255 with the 8-bit representation of a pixel in the image. The intensity values were plotted for C and T lines of the positive (d) and negative (e) ICT kits. The intensity values (d and e) were related to colour band intensity of C and T lines in the strips. S indicates sample hole.

Figure 4 in Improved diagnostic sensitivity of human strongyloidiasis using point-of-care mixed recombinant antigen-based immunochromatography

Figure 4. Representative results of the NIE, SsIR, and NIE-SsIR ICT kits, Positive, positive pooled serum samples; Negative, negative pooled serum samples; Hc, healthy control; Ss, proven strongyloidiasis; Gl, giardiasis; Eh, amoebiasis; Bh, blastocystosis; Ov, opisthorchiasis; Fg, fascioliasis; Ph, paragonimiasis; Tn, taeniasis; Cc, cysticercosis; Se, sparganosis; Hw, hookworm infections; Al, ascariasis; Tt, trichuriasis; Ts, trichinellosis; Ac, angiostrongyliasis; Gs, gnathostomiasis; Cp, capillariasis. The intensity cut-off levels for a positive result of the NIE, SsIR, and NIE-SsIR ICT kits were 1, 1, and>0.5, respectively by the naked eye and <164, <164, and <167, respectively by the in-house strip reader. The "+" and "—" symbols indicated positive and negative results.

opencc-by-4.0May 2023View details →

Development of a national point-of-care ultrasound training course for physicians in Japan: A 3-year evaluation

Purpose: Point-of-care ultrasound (POCUS) allows bedside clinicians to acquire, interpret, and integrate ultrasound images into patient care. Although the availability of POCUS training courses has increased, the educational effectiveness of these courses is unclear. Methods: From 2017 to 2019, we investigated the educational effectiveness of a standardized 2-day hands-on POCUS training course and changes in pre- and post-course exam scores in relationship to participants’ (n = 571) clinical rank, years of POCUS experience, and frequency of POCUS use in clinical practice. Results: The mean pre- and post-course examination scores were 67.2 (standard deviation [SD] 12.3) and 79.7 (SD 9.7), respectively. Higher pre-course examination scores were associated with higher clinical rank, more years of POCUS experience, and more frequent POCUS use (p < 0.05). All participants showed significant changes in pre- to post-course exam scores. Though pre-course scores differed by clinical rank, POCUS experience, and frequency of POCUS use, differences in post-course scores according to participant baseline differences were non-significant. Conclusion: A standardized hands-on POCUS training course is effective for improving POCUS knowledge regardless of baseline differences in clinical rank, POCUS experience, or frequency of POCUS use. Future studies shall evaluate changes in POCUS use in clinical practice after POCUS training.

ClinicalTrials.gov40/100

Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

ClinicalTrials.gov study NCT05413551. IPD Sharing: YES. Countries: 1. Publications: 1.

opencc-zeroFeb 2020View details →

dryad36/100

Data from: Population-based screening for hepatitis C antibodies and active infection using a point-of-care test in a low prevalence area

Background. Data on the true prevalence of hepatitis C virus (HCV) infection in the general population is essential to health policies. We evaluated a program implementing free universal HCV screening using a non-invasive point-of-care test (POCT) (OraQuick-HCV rapid test) in oral fluid in an urban area in Valencia, South-Eastern Spain. Methods. A cross-sectional study was performed during 2015-2017. Free HCV screening was offered by regular mail to 11,500 individuals aged 18 and over, randomly selected from all census residents in the Health Department. All responding participants filled in a questionnaire about HCV infection risk factors and were tested in their tertiary Hospital. In those with a positive POCT, results were confirmed by enzyme-immunoassay and HCV-RNA. Results. 1,206 persons agreed to participate (response rate: 11.16%). HCV antibodies were detected in 19 (1.60%) cases (age-sex standardized rate: 1.31%; 95%CI: 0.82-2.07), but only 8 showed positive HCV-RNA (age-sex standardized rate: 0.56%; 95%CI: 0.28-1.14). The majority (89%) of the cases were born before 1965 and 74% had at least one known risk factor for HCV infection. All anti-HCV positive individuals were already aware of their infection, and no undiagnosed cases were detected. The performance of the POCT was excellent for detecting active infection. Conclusions. These preliminary data suggest that HCV population screening with a POCT is feasible but, in our setting, mailing recruiting is not effective (11% response rate). The low prevalence of HCV antibodies and active infection in the participant population (with no new diagnoses made) suggests that, in our setting, underdiagnosis may be uncommon. Files uploaded include the study database (Stata v.13) and the do.file of the study.

zenodo36/100

COMPASS: A magnetic particle-based method for rapid and highly sensitive medical point-of-care diagnostic

This Git consists of all data sets used for generating the figures for the manuscript: COMPASS: A magnetic particle-based method for rapid and highly sensitive medical point-of-care diagnostic Specific information can be find in the readme

opencc-by-4.0Sep 2022View details →

closedIPD-NOFeb 2026View details →

Point-of-care Management of Coagulopathy in Lung Transplantation

ClinicalTrials.gov study NCT03598907. IPD Sharing: NO. Countries: 1. Publications: 16.

The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners

ClinicalTrials.gov study NCT04977050. IPD Sharing: YES. Countries: 1. Publications: 2.

restrictedIPD-UNDECIDEDFeb 2026View details →

Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

ClinicalTrials.gov study NCT01921452. IPD Sharing: Not stated. Countries: 1. Publications: 1.

Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria

ClinicalTrials.gov study NCT04501419. IPD Sharing: YES. Countries: 1. Publications: 1.

More Than a Machine: Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Uganda

ClinicalTrials.gov study NCT04517825. IPD Sharing: YES. Countries: 1. Publications: 1.

SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access

ClinicalTrials.gov study NCT04227145. IPD Sharing: YES. Countries: 1. Publications: 5.

restrictedIPD-UNDECIDEDFeb 2026View details →

Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

ClinicalTrials.gov study NCT00871286. IPD Sharing: Not stated. Countries: 1. Publications: 3.

restrictedIPD-UNDECIDEDFeb 2026View details →

Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)

ClinicalTrials.gov study NCT04793750. IPD Sharing: Not stated. Countries: 1. Publications: 22.