The need for primary quality control of commercially available immunoassay kits
Article Abstract:
In order to ensure the accuracy of laboratory tests and their results, a quality assurance program is needed to monitor the quality of the tests and to maintain high laboratory standards. Primary quality control (PQC) is needed at the national and international levels. Such a program should be established by the World Health Organization (WHO). The regulations established by such a program should apply to manufactures of laboratory test kits and products. Manufacturers should test their products prior to marketing and routinely thereafter to ensure that the quality of the product is maintained and that it lives up to the standards established by the PQC program. Reports of variations in test results obtained using test kits that are supposed to be standardized to give the same results all of the time are not uncommon. Several test kits that use radioimmunoassay (RIA, the use of specific radioactively labelled antibodies to identify a specific substance in a blood, urine or tissue sample) have been reported to produce differing results. Although the test kits are made and marketed by different companies, the tests should yield similar results when the same reference standards are used. When test kits do not yield the same results, it is usually caused by a problem related to the quality of the kit and not the reference standard. In Japan, in 1986, the Japan Radioisotope Association examined RIA kits produced by Japanese companies. It was found that one company was marketing a test kit (for luteinizing hormone) that gave laboratory results of patient samples that were inconsistent with test results obtained using other assays. The result was that the company stopped marketing the test kit. It is concluded that quality assurance is very important to the clinical laboratory for the accurate diagnosis of test results, and that the WHO should establish such a program. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of Clinical Pathology
Subject: Health
ISSN: 0021-9746
Year: 1991
User Contributions:
Comment about this article or add new information about this topic:
Aircraft air quality research
Article Abstract:
Research into ways of improving aircraft cabin air quality is discussed. The Cabinair consortium project aims to measure air quality during flights, assess environmental control devices and design new air distribution and filtration systems.
Publication Name: Occupational Safety & Health
Subject: Health
ISSN: 0143-5353
Year: 2001
User Contributions:
Comment about this article or add new information about this topic:
Measuring quality of care for essential hypertension
Article Abstract:
An audit tool for measuring the quality of care for essential hypertension is described.
Publication Name: Holistic Nursing Practice
Subject: Health
ISSN: 0887-9311
Year: 2001
User Contributions:
Comment about this article or add new information about this topic:
- Abstracts: The distribution and mortality impact of chronic energy deficiency among adult Nigerian men and women. Energy requirements: general principles
- Abstracts: Keeping foods of animal origin safe. Resurgence of communicable diseases in Europe. Emerging foodborne diseases
- Abstracts: Intraoral contact allergy: a literature review and case reports. Labial talon cusp: a case study of pre-European-contact American Indians
- Abstracts: Tamoxifen for prevention of breast cancer. Valrubicin for bladder cancer. Trastuzumab and capecitabine for metastatic breast cancer
- Abstracts: Hip pain. An unusual case of atlanto-axial subluxation