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The quality control samples at concentration levels 200 and 2000 pg/mL gave a total imprecision of 7.4% and 4.2%, respectively, (n = 95).
Normalization was either on total on column protein amount, with median (average) error of 22% 24%%) or on that of an endogenous mid concentration range reference (Ppia), giving median (average) total imprecision of 19% 20%%).
The limit of quantification and the total imprecision of the assay were 0.8 mg/L and <5%, respectively.
On the AxSYM platform (Abbott Labs, North Chicago, IL), the method has a measurement range of 3 100 pmol/L and a total imprecision of 6 9%.
Structural equation model analysis showed that these two biomarkers have average total imprecision of about 30%, which is much higher than the laboratory error.
The assay for cTnI has a lower level of detection of 6 ng/l, a 99th percentile value of 40 ng/l and a total imprecision of 10% at a concentration of 30 ng/l.
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The total imprecision (coefficient of variation, CV) of the instrument for the analytes were 1.1% at 0.9 mmol/l for TG, 0.8% at 8 mg/l for hs-CRP and 1.0% at 4.4 mmol/l for glucose.
The sensitivity [and total imprecision (coefficient of variation, CV)] of the validated analytical methods were as follows: FSH <0.1 IU/l (<6%), LH <0.1 IU/l (<6%), hCG <0.1 IU/l (<8%), estradiol 55 pmol/l (10%), progesterone 0.6 nmol/l (<8%), SHBG 0.02 nmol/l (10%), androstenedione 0.08 nmol/l (10%) and total testosterone 0.17 nmol/l (5%).
To be classified as high sensitivity, a cardiac troponin assay should meet two criteria: firstly, its total imprecision (coefficient of variation) at the 99th centile of the healthy reference population should be 10% or less; secondly, measureable concentrations above the limit of detection and below the 99th centile should be attainable for at least 50% of the reference population.
Results: Total imprecision (CV) of 10%and20%0% were seen at 0.09 and 0.07 μg/l, respectively.
Total imprecision (Interassay coefficient of variation) is 9.4% at 22 nmol/l.
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