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LLOQLower Limit of Quantification
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Intraday precision and accuracy were assessed at the lower, middle, high, and lower limit of quantification quality control samples LQC, MQC, HQC, and LLOQ in six replicates for both of the analytes, while interday precision and accuracy were assessed for three consecutive days by using quality control samples.
The lower limit of quantification during validation was 0.005 [micro]g/mL and the limit of detection was 0.0025 [micro]g/mL.
Nonstandard Abbreviations XylB: Xylose dehydrogenase from Caulobacter crescentus SPC: Summary of product characteristics R1: Reactive 1 R2: Reactive 2 LoD: Limit of detection LoQ: Limit of quantification LoB: Limit of blank LLoQ: Lower limit of quantification ROC: Receiver operating characteristics EMA: European Medicines Agency CDER: Center for Drug Evaluation and Research AUC: Area under the curve ND: Not determined.
Among the subjects, 50% achieved a titer greater than or equal to the lower limit of quantification to all four test strains (Pfizer, unpublished data).
When the instrument provides a readout of "Less than the Lower Limit of Quantification, HCV RNA detected," many labs combine that with the "Target Not Detected" result, and in their LIS system it simply indicates the result is either negative or less than the LLOQ, suggesting that nothing was measured.
* Transient viremia intermittently detected by ultrasensitive assays may last up to 3 weeks, so results of viral load tests repeated too soon after the first positive result may still be positive, depending on the assay variance near the lower limit of quantification.
The qualified ELISA had a minimum detection limit of 0.06 [micro]g/mL, a reliable lower limit of detection of 0.09 [micro]g/mL, and a lower limit of quantification in undiluted serum specimens of 3.0 [micro]g/mL anti-PA IgG.
The lower limit of quantification (LLoQ) was 0.40 ng/L (the lowest standard concentration with back-interpolated recovery bias <20% and CV <20%).
Lower limit of quantification chemotherapy is well-established and approved for treatment of thyroid cancer [1-4].
Intra-Batch Precision was established by injecting five samples of four different concentrations (0.2812 ug/ml - 13.50 ug/ml) including lower limit of quantification prepared in plasma.
Specifically, limit of detection (LUD), lower limit of quantification (LLOQ), intra- and interassay precision, linearity, volume effect, matrix effects, anatomical (venous blood vs finger prick) effect, and storage/transport stability were determined.
[3] Nonstandard abbreviations: MRM, multiple reaction monitoring; [MRM.sup.3], MRM with multistage fragmentation; Q/LIT, quadrupole linear ion trap; WCX, weak cation exchange; SPE, solid-phase extraction; HILIC, hydrophilic interaction liquid chromatography; HMMA, 4-hydroxy-3-methoxymethamphetamine; EQA, external quality assurance; LLOQ, lower limit of quantification.
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