Quantitative methods NCCLS guidelines

Carryover is defined as the unintended transfer of a quantity of analyte or reagent by an analytical system from one specimen reaction into a subsequent one. Because carryover introduces error into the analytical results from the subsequent reaction, it should be minimized. Details for determining the extent of analyte carryover are described in the NCCLS document EP 10-A2, Preliminary Evaluation of Quantitative Clinical Laboratory Methods Approved Guideline Second Edition. More elaborate protocols are required to evaluate the extent of reagent carryover. Most... 

National Committee for Clinical Laboratory Standards (NCCLS). Prehminary evaluation of quantitative clinical laboratory methods, approved guideline-second edition. NCCLS document EP10-A2. Wayne, PA NCCLS, 2002. 

For quantitative methods, the ICH guidelines recommend validating a range that extends 20% below the lower end of the range and 20% above the upper end of the range (for content uniformity the range is extended to 70-130% of the SOP range). For the linearity portion of the method. National Committee for Clinical Laboratory Standards [NCCLS (9)] recommends at... 

National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative analytical methods Proposed Guideline. NCCLS publication EP6-P. Villanova, PA NCCLS, 1986. 

NCCLS. Quantitative molecular methods for infectious diseases approved guideline. Vol. 23 (28). Wayne, Pa NCCLS, 2003 1-55,... 

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