In this 2nd Pearl, we will discuss the quality requirements (i.e. Fractional Methaemoglobin Fractional Carboxyhaemoglobin ± 2.0% . ± 3 up to 100 g/L; 3% > 100 g/L . Total Error (TE) and Total Allowable Error (TEa) Total error and total allowable error are useful when choosing the SPC rule(s) to apply to a test. Bilirubin, total Blood gas pO2 Blood gas pCO2 Blood gas pH Calcium, total Carbamazepine Chloride Cholesterol, high density lipoprotein (HDL) Cholesterol, total Complement C3 Complement C4 Cortisol Creatine kinase (CK) Creatine kinase isoenzymes (CK-MB) Creatinine Digoxin Ethosuximide Free thyroxine (Free T4) Gentamicin Glucose Fourteen (78%) out of the total eighteen patients with positive blood culture, showed median PCT concentrations greater than the cut-off values of 0.15 μg/L. Describe how drug therapy is impacted by pharmacokinetics, pharmacodynamics, and pharmacogenetics. List various clases of drugs that require TDM. Fractional Oxyhaemoglobin ± 3 up to 75.0%; 4% > 75.0% . CLIA, CFR Part 439 a. Medullary thyroid carcinoma (MTC) is a malignant tumor of the thyroid cells C cells, accounting for about 2–5% of thyroid cancers [].Calcitonin (CT), the main C cell secretory product, is considered a sensitive and specific marker for the diagnosis and follow-up of MTC [].However, CT assays suffer pre-analytic and analytic drawbacks: i. TOTAL ALLOWABLE ERROR LIMITS 60 PINELAND DRIVE AUBURN HALL SUITE 305 NEW GLOUCESTER, ME 04260 PHONE: 207-926-1125 ∆ TOLL FREE: 1-877-786-3424 ∆ FAX: 207-926-1126 www.sundiagnostics.us TAE Limits Table rev20120725 Note: Sources are not listed if they agree with CLIA. SOURCES: 1. Learning objectives of this February 2019 Pearl of Laboratory Medicine: Discuss the rationale for therapeutic drug monitoring (TDM). Procalcitonin (PCT) is a stable 116-amino acid precursor molecule to the hormone calcitonin. Slide 2: First of all, let’s discuss why we need these quality specifications. Deming regression analysis of 1116 plasma or serum samples with PCT results detected across a dynamic assay range of 0.02–100 µg/L using the ARCHITECT PCT assay showed a good correlation with comparators ().In 322 samples from sites in Germany, South Africa and Vietnam, the ARCHITECT PCT assay compared with the Roche Cobas ® assay had a slope of 0.82 (95% … the allowable total error, also known as TEa) used to define a patient result as unreliable. Introduction. Procalcitonin (PCT) is a stable 116-amino acid precursor molecule to the hormone calcitonin. Discuss analytical methods available for TDM This free percent error calculator computes the percentage error between an observed value and the true value of a measurement. The intra-assay and total imprecision were tested by analysis of two control levels (0.342 and 10.4 ug / L) of human serum origin and one self-prepared serum pool. Conclusion: The miniVIDAS PCT assay can be used for diagnostic purposes in clinical laboratories. To the Editor.