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The document discusses concepts of Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) for analytical tests. The LoB is the highest concentration expected to be found when replicates of a blank sample containing no analyte are tested. The LoD is the lowest concentration likely to be reliably distinguished from the LoB. It is determined from replicates of a low concentration sample and the LoB value. The LoQ is the lowest concentration that meets goals for accuracy and precision, such as criteria set by CLIA. It must have a total error below the allowable total error.
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This document provides an overview of high performance liquid chromatography (HPLC). It describes HPLC as a type of liquid chromatography that uses small particle sizes as the stationary phase to separate compounds dissolved in a solution. The key components of an HPLC system are a solvent delivery pump, injector, column, detectors, and data collection system. Different types of columns include normal phase, reverse phase, size exclusion, and ion exchange. Factors that affect HPLC separation include column length and temperature, flow rate, particle size, and mobile phase properties. HPLC is used for quantitative and qualitative analysis in various applications like analyzing drugs, pollutants, and food/drug products.
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Lo b, lod
- 1. Concept of LoB, LoD and LoQ
- 2. ● Clinical and Laboratory Standards Institute (CLSI) has published the guideline EP17, Protocols for Determination of Limits of Detection and Limits of Quantitation
- 3. LoB ● Why it is necessary???? ● Ans : A blank (zero) sample can produce an analytical signal that might otherwise be consistent with a low concentration of analyte.
- 4. ● LoB is estimated by measuring replicates of a blank sample and calculating the mean result and the standard deviation (SD).
- 5. LoB = mean blank + 1.645(SD blank)
- 6. LOD ● LoD is the lowest analyte concentration likely to be reliably distinguished from the LoB and at which detection is feasible. ● LoD is determined by utilising both the measured LoB and test replicates of a sample known to contain a low concentration of analyte.
- 7. LoD = LoB + 1.645(SD low concentration sample)
- 8. LOD = 0.87+(1.645*0.745) = 2.10
- 9. -25 -5 15 35 55 75 95 115 0 5 10 15 20 25 30 35 40 45 50 LOB LOD To understand and At LOD level
- 10. LOQ ● LoQ is the lowest concentration at which the analyte can not only be reliably detected but at which some predefined goals for bias and imprecision are met. ● So TE for LOQ should be less than TEa. ● TEa defined acc to CLIA criteria.