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CytoPAN-Portable cellular analyses for rapid point-of-care cancer diagnosis.

ABSTRACT: Rapid, automated, point-of-care cellular diagnosis of cancer remains difficult in remote settings due to lack of specialists and medical infrastructure. To address the need for same-day diagnosis, we developed an automated image cytometry system (CytoPAN) that allows rapid breast cancer diagnosis of scant cellular specimens obtained by fine needle aspiration (FNA) of palpable mass lesions. The system is devoid of moving parts for stable operations, harnesses optimized antibody kits for multiplexed analysis, and offers a user-friendly interface with automated analysis for rapid diagnoses. Through extensive optimization and validation using cell lines and mouse models, we established breast cancer diagnosis and receptor subtyping in 1 hour using as few as 50 harvested cells. In a prospective patient cohort study (n = 68), we showed that the diagnostic accuracy was 100% for cancer detection and the receptor subtyping accuracy was 96% for human epidermal growth factor receptor 2 and 93% for hormonal receptors (ER/PR), two key biomarkers associated with breast cancer. A combination of FNA and CytoPAN offers faster, less invasive cancer diagnoses than the current standard (core biopsy and histopathology). This approach should enable the ability to more rapidly diagnose breast cancer in global and remote settings.

SUBMITTER: Min J

PROVIDER: S-EPMC8217912 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSensitive and specific detection of malarial parasites is crucial in controlling the significant malaria burden in the developing world. Also important is being able to identify life threatening Plasmodium falciparum malaria quickly and accurately to reduce malaria related mortality. Existing methods such as microscopy and rapid diagnostic tests (RDTs) have major shortcomings. Here, we describe a new real-time PCR-based diagnostic test device at point-of-care service for resource-limited settings.MethodsTruenat® Malaria, a chip-based microPCR test, was developed by bigtec Labs, Bangalore, India, for differential identification of Plasmodium falciparum and Plasmodium vivax parasites. The Truenat Malaria tests runs on bigtec's Truelab Uno® microPCR device, a handheld, battery operated, and easy-to-use real-time microPCR device. The performance of Truenat® Malaria was evaluated versus the WHO nested PCR protocol. The Truenat® Malaria was further evaluated in a triple-blinded study design using a sample panel of 281 specimens created from the clinical samples characterized by expert microscopy and a rapid diagnostic test kit by the National Institute of Malaria Research (NIMR). A comparative evaluation was done on the Truelab Uno® and a commercial real-time PCR system.ResultsThe limit of detection of the Truenat Malaria assay was found to be <5 parasites/?l for both P. falciparum and P. vivax. The Truenat® Malaria test was found to have sensitivity and specificity of 100% each, compared to the WHO nested PCR protocol based on the evaluation of 100 samples. The sensitivity using expert microscopy as the reference standard was determined to be around 99.3% (95% CI: 95.5-99.9) at the species level. Mixed infections were identified more accurately by Truenat Malaria (32 samples identified as mixed) versus expert microscopy and RDTs which detected 4 and 5 mixed samples, respectively.ConclusionThe Truenat® Malaria microPCR test is a valuable diagnostic tool and implementation should be considered not only for malaria diagnosis but also for active surveillance and epidemiological intervention.

Project description:PurposeTo develop a disposable point-of-care portable perfusion phantom (DP4) and validate its clinical utility in a multi-institutional setting for quantitative dynamic contrast-enhanced magnetic resonance imaging (qDCE-MRI).MethodsThe DP4 phantom was designed for single-use and imaged concurrently with a human subject so that the phantom data can be utilized as the reference to detect errors in qDCE-MRI measurement of human tissues. The change of contrast-agent concentration in the phantom was measured using liquid chromatography-mass spectrometry. The repeatability of the contrast enhancement curve (CEC) was assessed with five phantoms in a single MRI scanner. Five healthy human subjects were recruited to evaluate the reproducibility of qDCE-MRI measurements. Each subject was imaged concurrently with the DP4 phantom at two institutes using three 3T MRI scanners from three different vendors. Pharmacokinetic (PK) parameters in the regions of liver, spleen, pancreas, and paravertebral muscle were calculated based on the Tofts model (TM), extended Tofts model (ETM), and shutter speed model (SSM). The reproducibility of each PK parameter over three measurements was evaluated with the intraclass correlation coefficient (ICC) and compared before and after DP4-based error correction.ResultsThe contrast-agent concentration in the DP4 phantom was linearly increased over 10 min (0.17 mM/min, measurement accuracy: 96%) after injecting gadoteridol (100 mM) at a constant rate (0.24 ml/s, 4 ml). The repeatability of the CEC within the phantom was 0.997 when assessed by the ICC. The reproducibility of the volume transfer constant, Ktrans , was the highest of the PK parameters regardless of the PK models. The ICCs of Ktrans in the TM, ETM, and SSM before DP4-based error correction were 0.34, 0.39, and 0.72, respectively, while those increased to 0.93, 0.98, and 0.86, respectively, after correction.ConclusionsThe DP4 phantom is reliable, portable, and capable of significantly improving the reproducibility of qDCE-MRI measurements.

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CytoPAN-Portable cellular analyses for rapid point-of-care cancer diagnosis.

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