By Lindsy Hengesbach M.S., MB(ASCP)CM, John A. Gerlach Ph.D., D(ABHI) (auth.), Peter Hu, Madhuri Hegde, Patrick Alan Lennon (eds.)
This well timed booklet covers the necessity to recognize scientific practices for all these interested in molecular laboratory technological know-how. the sector of molecular medication is evolving at an surprising pace. Propelled through the recent insights and applied sciences, advances are being made at an unheard of fee. With twin degree given to today’s breakthroughs, this publication is a suite of the most up-tp-date practices correct to the medical molecular laboratorian. It starts off with an introductory part on concepts and strategy. It then offers 4 separate sections on infectious affliction, oncology, pre/post-natal, and identification checking out, with particular chapters essentially outlining medical protocols utilized in day-by-day practice.
Modern medical Molecular Techniques cuts to the guts of what's crucial for the working towards molecular laboratory scientist. it really is a superb source for these working inside or seeking to manage a scientific molecular laboratory.
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This well timed e-book covers the necessity to recognize medical practices for all these inquisitive about molecular laboratory technological know-how. the sector of molecular drugs is evolving at an impressive pace. Propelled via the hot insights and applied sciences, advances are being made at an unparalleled fee. With twin degree given to today’s breakthroughs, this booklet is a suite of the most up-tp-date practices suitable to the medical molecular laboratorian.
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Extra resources for Modern Clinical Molecular Techniques
D. (*) Molecular Pathology Laboratory, University of Oklahoma Health Sciences Center, 940 Stanton L. C. Hu et al. 1007/978-1-4614-2170-2_3, © Springer Science+Business Media, LLC 2012 23 24 C. T. 551) . While one might expect perfect alignment of requirements between CLIA and the various accrediting agencies, this is not always the case. Therefore, it is important to understand the speciﬁc requirements set forth by the applicable accrediting agencies to meet CLIA regulations in regard to test veriﬁcation, validation, reporting, quality control/assurance, proﬁciency testing, etc.
No deﬁnitive protocols for statistical analysis of data generated during validation/veriﬁcation studies have been established; however, several publications provide valuable guidance on this topic, which is beyond the scope of this chapter [7–9, 12–25]. Consultation with a statistician before validation/veriﬁcation implementation may ensure a more robust plan. Also, a plan for obtaining suitable samples and controls and calibrators for the formal evaluation process should be prepared at this time.
Therefore, it is important to understand the speciﬁc requirements set forth by the applicable accrediting agencies to meet CLIA regulations in regard to test veriﬁcation, validation, reporting, quality control/assurance, proﬁciency testing, etc. It is also important to understand the FDA clearance designations for laboratory tests and reagents to determine the type of validation or veriﬁcation that must be performed. 3(a)) . Laboratory tests are FDAcleared/approved for IVD use through two main processes, premarket notiﬁcation [510(k)] or premarket approval (PMA).