Dataset Information

Establishing Sex-Dependent Reference Intervals for KL-6 in Danish Adults.

ABSTRACT: Krebs von den Lungen-6 (KL-6) is a promising biomarker for the diagnosis and prognosis of interstitial lung disease. However, reference intervals in Northern Europeans remain to be established using a latex-particle-enhanced turbidimetric immunoassay. The participants were Danish blood donors subjected to strict health requirements. Analyses were performed using the Nanopia KL-6 reagent on the cobas 8000 module c502. Sex-partitioned reference intervals were determined using a parametric quantile approach according to the Clinical and Laboratory Standards Institute guideline EP28-A3c. The study included 240 participants-121 females and 119 males. The common reference interval was 59.4-398.5 U/mL (95% confidence intervals (CI) for the lower and upper limits were 47.3-71.9 and 369.5-430.1, respectively). For females, the reference interval was 56.8-324.0 U/mL (95% CIs for the lower and upper limits were 36.1-77.6 and 303.3-344.7, respectively). For males, the reference interval was 51.5-448.7 U/mL (95% CIs for the lower and upper limits were 32.8-71.2 and 397.3-508.1, respectively). These results emphasize the importance of sex partitioning when evaluating KL-6 reference intervals. The reference intervals increase the clinical applicability of the KL-6 biomarker and provide a basis for future scientific studies of its utility in patient management.

SUBMITTER: Bruun SB

PROVIDER: S-EPMC10253194 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Establishing Sex-Dependent Reference Intervals for KL-6 in Danish Adults.

Bruun Stine Bakkensen SB Madsen Jeppe Buur JB Brasen Claus Lohman CL

Diagnostics (Basel, Switzerland) 20230602 11

Krebs von den Lungen-6 (KL-6) is a promising biomarker for the diagnosis and prognosis of interstitial lung disease. However, reference intervals in Northern Europeans remain to be established using a latex-particle-enhanced turbidimetric immunoassay. The participants were Danish blood donors subjected to strict health requirements. Analyses were performed using the Nanopia KL-6 reagent on the cobas 8000 module c502. Sex-partitioned reference intervals were determined using a parametric quantile ...[more]

PMID: 37296803

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Project description:BackgroundAbnormal intra-pregnancy haematological variables are associated with adverse feto-maternal outcomes. However, the reference intervals (RIs) employed in sub-Saharan Africa to inform clinical decisions are generally imported. Since RIs are influenced by age, geographical location, and race, we hypothesized that context specific RIs should be established in Ghana to contextualize intra-pregnancy decision making.MethodsThis cross-sectional study retrospectively retrieved data of 333 pregnant women with no known clinically determined intra-pregnancy complications; 22 participants in their first trimester (T1; 1-13 weeks), 177 in their T2 (14-27 weeks), and 132 in T3 (28-41 weeks). RIs for haematological parameters were non-parametrically determined at 2.5th and 97.5th percentiles in accordance with CLSI guidance document EP28-A3c. Two-sample comparisons were undertaken using Wilcoxon rank-sum tests whereas more than two-sample comparisons were undertaken using Kruskal-Wallis test. Statistical significance was set at p <0.05 under the two-tailed assumptions.ResultsIn accordance with WHO trimester-specific haemoglobin cutoffs, anaemia prevalence was a moderate (T1: 36.4%; 8/22 & T2: 31.6%; 56/177) to severe (T3:68.0%; 90/132) public health problem. Additionally, 9.3% (31/333) individuals had high gestational haemoglobin levels (Hb >13.0 g/dL). Moreover, haemoglobin (T2: 8.6-14.3 vs T3: 7.5-13.6 g/dL), MCH (T2: 22.5-69.8 vs T3: 21.6-31.9 pg), MCHC (T2: 30.2-51.8 g/L vs T3: 30.5-37.9 g/L), TWBC (T2: 4.0-13.4 vs T3: 4.1-13.0 x 109/L) required trimester specific RIs, compared to RBC (2.8-5.1 x 1012/L), MCV (66.2-100.2 fL), and platelet counts (106.3-388.3 x 109/L) that each required combined reference intervals.ConclusionsThe intra-pregnancy haematological RIs determined have appreciable lower limits; there is the need to determine context-specific thresholds for haematological variables predictive of positive and/or adverse maternal and infant health outcomes.

Project description:BackgroundReference intervals are assessment tools for interpretation of clinical test results. These intervals describe the dispersion of test parameter values of apparently healthy persons in defined populations as health status indicators. Using reference intervals obtained and validated in populations outside the geographical region of derivation for medical decision-making may impact negatively on clinical interpretation and patient management. Many countries have established their reference values, current studies on these data for Nigeria are however scarce. Determination of clinical biochemistry reference intervals for young Nigerian adults which is of particular importance in routine clinical management and conduct of clinical trials in response to existing and emerging diseases will add significantly to the existing body of knowledge.ObjectiveThe objective was to establish reference intervals for 24biochemistry analytes among Nigerians aged 18 to 26 years.MethodsThis was a cross-sectional study among 7,797 consenting male and female military applicants aged 18 to 26 years from 37 States of Nigeria. It was a total study among volunteers for military service. Blood samples were collected and subjected to serological testing for HIV-1 and 2, hepatitis-B, malaria, pregnancy and haematuria to restrict our study population to apparently healthy participants. Biochemical assays were performed on 6,169 participant samples that met the inclusion criteria. Generated data was entered into MS Excel® and exported into SPSS® software version 16 for analysis. Statistical tools used were frequencies, median, mid 95th percentile range with 2.5th and 97.5th percentiles as limits. Reference intervals were estimated using nonparametric methods. No intergender statistical comparison was made.ResultsComplete records were obtained for 6,169 eligible participants. Median values and associated reference intervals were similar in both genders.ConclusionThe findings from this study will help in clinical decision-making and play a significant role in supporting the current global rapid expansion of clinical trials in response to the urgent need for preventive and therapeutic solutions to existing and emerging diseases.

Dataset Information

Establishing Sex-Dependent Reference Intervals for KL-6 in Danish Adults.

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Establishing Sex-Dependent Reference Intervals for KL-6 in Danish Adults.

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