Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

AbstractA revised framework for the regulation of in vitro diagnostic devices (IVDs) came into force in Australia on July 1, 2010 that aims to ‘ensure that public and personal health are adequately protected’, but which instead may lead to adverse outcomes in clinical diagnosis and management. The regulatory process aims to regulate all IVDs, including those used by clinical diagnostic laboratories, which are already subject to scrutiny as part of the current laboratory accreditation process. The IVD regulatory process initiated in Australia is similar to that used in Canada, but different to that currently operating in the USA and Europe. However, it is feasible that other countries will in time adopt a similar regulatory framework, given that many countries are involved in the development process. In this opinion paper, the regulatory process for IVDs across several geographies are outlined, as are some benefits and weaknesses of the new regulatory process now applied to Australia, as potentially planned for other regions of the world.

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Application of the Department of Health and Human Services proposed waived status requirements for in vitro diagnostic testing devices: case study

Clinical Chemistry ◽

10.1093/clinchem/43.9.1610 ◽

1997 ◽

Vol 43 (9) ◽

pp. 1610-1617 ◽

Cited By ~ 2

Author(s):

Sharon S Ehrmeyer ◽

Ronald H Laessig

Keyword(s):

Reference Range ◽

Clinical Laboratory ◽

Health Care Financing ◽

Diagnostic Testing ◽

Test System ◽

Department Of Health ◽

In Vitro Diagnostic ◽

Clinical Laboratory Testing

Abstract The CLIA’88 classified all clinical laboratory testing as waived, moderate, or high complexity. The eight original waived tests were characterized as simple, accurate, error-free, risk-free, and suitable for home use by nonlaboratory professionals. The subjective nature of the classification process was challenged immediately. The Clinical Laboratory Improvement Advisory Committee asked the CDC and the Health Care Financing Administration to develop objective criteria that included assessment of performance by field-test and in-house data. We examined the efficacy of the CDC protocol with empirical data from the HemoCue B-Hemoglobin Test System® submission, to assess operator competency, intra-/interoperator and between-site imprecision, and accuracy. Non-laboratory-trained operators demonstrated 2–3% imprecision (40–200 g/L). Accuracy studies yielded a slope of 1.01, an intercept of 3.53 g/L, and r of 1.00 (52–230 g/L). Results met the protocol’s Tonks’ criterion for imprecision (less than one-fourth of the reference range).

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Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

10.3403/30114788u ◽

2015 ◽

Keyword(s):

Anticoagulant Therapy ◽

Medical Devices ◽

Oral Anticoagulant ◽

Laboratory Testing ◽

Clinical Laboratory ◽

Oral Anticoagulant Therapy ◽

Monitoring Systems ◽

Self Testing ◽

Clinical Laboratory Testing

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