Immunoassay (RIA) Laboratory
The Immunoassay laboratory (RIA laboratory) was established at the National hospital of Sri Lanka (NHSL) in 1989 as a tertiary referral laboratory. It is situated in the ground floor of the laboratory complex. The laboratory provides comprehensive laboratory services for the NHSL and forty six other government hospitals island wide. As a referral laboratory it is committed in providing free quality medical laboratory testing services for all the government hospitals and health institutions.
Laboratory tests and technology
The laboratory had been initially using in-house prepared radio immunoassay reagents for testing in cost effective manner. Currently the laboratory uses traceability established internationally accepted commercially prepared radioimmunoassay reagent kits. In addition, the modern technology of chemiluminescence immunoassay has been introduced to perform laboratory tests using fully automated analyzer and internationally accepted commercial reagents.
The laboratory performs specialized hormone assays such as Growth hormone, Cortisol, Luteinizing hormone, Follicle stimulating hormone to diagnose endocrine disorders, tumour markers such as, Cacinoembryonic antigen, Prostate specific antigen, Alpha feto-protein for the diagnosis of malignancies. Dynamic function tests such as, Insulin tolerance test, Glucagon stimulation test, overnight, low dose, prolonged dexamethasone suppression tests, short synacthen test and growth hormone levels following oral glucose tolerance test are used for the evaluation of the pituitary and adrenal glands. Tests such as, Adrenocorticotrophic hormone and Parathyroid hormone are exclusively done by the RIA laboratory for the government health sector. Sample analysis of highly specialized tests such as, inferior petrosal sinus sampling (IPSS) is also performed in collaboration with the endocrinology unit. The panel of laboratory tests has been recently expanded by introducing new tests such as, plasma aldosterone, plasma renin and urine microalbumin, some of which are very expensive and not freely available even in the private sector.
RIA laboratory also provides clinical advisory services, which includes the clinical interpretation of laboratory results, advice on appropriate selection of laboratory tests, investigation and monitoring strategies for individual patients and for specific diseases. There is close liaison with clinicians and other health care professionals within the community and other hospitals to ensure best practices in the use of the service.
Quality control procedure
Every assay is performed with the use of traceability established calibrators to generate reliable test results. The expected quality of the tests is maintained with the use of internationally accepted third party internal quality controls of low, medium and high levels. All the assays are performed by well trained medical laboratory technologists and all the results are technically and clinically validated by a laboratory panel consisting of the Consultant Chemical Pathologist, Postgraduate trainees in Chemical Pathology, medical officers, Biochemist and medical laboratory technologists.
Training and research
Apart from providing a comprehensive pathology service, the laboratory is capable of meeting the training requirements of various professionals such as, medical postgraduates, undergraduates and trainees in medical laboratory technology in the health sector. The laboratory also provides facilities for devising and conducting basic and applied research for the development of laboratory practice in chemical pathology.
The Immunoassay laboratory has qualified, experienced staff consisting of a Consultant chemical pathologist, Biochemist, senior medical laboratory technologist, six medical laboratory technologists and five other support staff.
Accreditation of the Immunoassay Laboratory
The process of laboratory accreditation to fulfill the requirements of the ISO- 15189- 2012 has been commenced with the improvements of quality system. The guidelines for sample acceptance from the National hospital as well as from out station hospitals have been prepared. The establishment of the primary sample traceability will be implemented through the â€œhanding over â€“taking overâ€™â€™ and â€˜â€™done- checkedâ€™â€™ procedures. An inter-laboratory comparison for hormones and tumour markers is a major requirement for accreditation.
Establishment of new tests
The Immunoassay laboratory will be equipped with latest immunoassay technology by purchasing a fully automated chemiluminescence immunoassay analyser to provide an efficient service for the government health sector. Tests such as, 25 â€“ OH vitamin D, serum IGF-1, estradiol and total testosterone are to be established in the near future. The laboratory has also planned to establish a comprehensive therapeutic drug monitoring system as a future development to fulfill the requirement of drug analysis.
Continuous proficiency development
An annual training plan is designed to improve the theoretical and practical knowledge of all the members of staff of the laboratory.
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