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Also, the number of women with availability of total hCG measurements varied for each gestational week and therefore reference range determinations were not equally reliable throughout gestation, particularly during very early and the third trimester of pregnancy.
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If the forecast range determination, presented in Section 2.4, is accurate, the set of the recorded values and the S-curve, modeled according to them, should be situated within or nearby the forecast's range in Fig. B1.
However, when the DLLME-SFO method was validated under optimal conditions, the range of values of limit of detection, limit of quantification, dynamic linearity range, determination of coefficient, enrichment factor and extraction recovery were (0.025 0.377 ng mL−1), (0.083 1.256 ng mL−1), (0.100 1.000 ng mL−1), (R2 = 0.990 0.999), (35 49), (69 98%) respectively.
Under optimal conditions, VALLME-SFO was validated in terms of limit of detection, limit of quantification, dynamic linearity range, determination of coefficient, enrichment factor and extraction recovery for which the respective values were (0.011 0.219 ng mL−1), (0.035 0.723 ng mL−1), (0.050 0.500 ng mL−1), (R2 = 0.992 0.999), (40 56), (80 106%).
Following these exclusions, 862 samples were included for clinical reference range determination.
Our data collection method was in accordance with the rigorous CLSI guidelines for determining laboratory reference ranges, which recommends a minimum of 153 subjects for a 95th percentile clinical reference range determination with 95% confidence [17].
Although the number of females was disproportionate to males (20% vs. 80%) in this study, the number of females included in reference range determination for each analyte was well within the guidelines of CLSI of 120 subjects[8].
This finding suggests a potential association of PA T6SS-2 withostst range determination.
Studies have increasingly shown NS1 to be involved in host range determination, yet the mechanism remains unclear.
Our work suggests that the control of monoallelic expression of VSG links at least three key-processes, namely antigenic variation, host range determination, and parasite development.
Thus component exchange possibly drives diversification of species into strains, which is not surprising since DNA-B components play a major role in host range determination [ 43].
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