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1.
J Appl Lab Med ; 8(3): 535-550, 2023 05 04.
Artigo em Inglês | MEDLINE | ID: mdl-36533519

RESUMO

BACKGROUND: Abnormal liver function is a common manifestation of human disease and may also occur in approved and investigational medications as drug-induced liver injury (DILI). Capillary blood collection devices may allow for more frequent and convenient measurement outside of the clinic. Validation of such approaches is lacking. METHODS: This prospective, biospecimens collection study evaluated the Tasso+ in patients with abnormal liver tests (NCT05259618). The primary objective was to define the concordance of alanine aminotransferase (ALT) obtained via Tasso+ compared to standard venipuncture. Secondary objectives included measurement of 14 other analytes and patient surveys. At the time of venipuncture, 2 Tasso+ samples were collected: one was centrifuged and shipped, and the other was refrigerated and shipped as whole blood. RESULTS: Thirty-six patients with elevated ALT values were enrolled. In total, 100 venipuncture, 50 Tasso+ centrifuged, and 48 Tasso+ whole blood samples were obtained. Tasso+ centrifuged samples demonstrated concordance correlation coefficients (CCC) of >0.99 for ALT, alkaline phosphatase (ALP), aspartate aminotransferase (AST), and total bilirubin and CCC >0.95 for albumin, chloride, enzymatic creatinine, serum glucose, magnesium, and phosphorus. Tasso+ whole blood showed CCC of >0.99 for AST, bilirubin total, and enzymatic creatinine and CCC >0.95 for ALT, ALP, albumin, magnesium, and phosphorus. Hemolysis was comparable across the 3 sample types, but its impact was reflected in the Tasso+ potassium data. Patient feedback indicated a very favorable patient experience. CONCLUSIONS: The capillary blood collection device, Tasso+, showed substantial to almost perfect concordance to standard venipuncture for measurement of abnormal liver function. Studies are ongoing to validate longitudinal sampling outside of the clinic. Clinicaltrials.gov Registration Number: NCT05259618.


Assuntos
Magnésio , Flebotomia , Humanos , Flebotomia/efeitos adversos , Estudos Prospectivos , Creatinina , Fosfatase Alcalina , Bilirrubina , Fígado , Fósforo , Albuminas
2.
J Lab Autom ; 20(2): 146-53, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25424385

RESUMO

Cell-based assays are essential tools used by research labs in a wide range of fields, including cell biology, toxicology, and natural product discovery labs. However, in some situations, the need for cell-based assays does not justify the costs of maintaining cell culture facilities and retaining skilled staff. The kit-on-a-lid assay (KOALA) technology enables accessible low-cost and prepackageable microfluidic platforms that can be operated with minimal infrastructure or training. Here, we demonstrate and characterize high-density KOALA methods for high-throughput applications, achieving an assay density comparable to that of a 384-well plate and usability by hand with no liquid-handling equipment. We show the potential for high-content screening and complex assays such as quantitative immunochemistry assays requiring multiple steps and reagents.


Assuntos
Avaliação Pré-Clínica de Medicamentos/instrumentação , Avaliação Pré-Clínica de Medicamentos/métodos , Ensaios de Triagem em Larga Escala/instrumentação , Ensaios de Triagem em Larga Escala/métodos , Microfluídica/instrumentação , Microfluídica/métodos , Imunoquímica/instrumentação , Imunoquímica/métodos
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