High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA).

Background: In the last decade, point of care testing (POCT) such as lateral flow immunoassays (LFIA) were developed for rapid TSH measurement. Most of these TSH-LFIAs are designed for qualitative measurements (i.e., if TSH values > 5, or >15 IU/L) and as screening tests for primary hypothyroidism in children and adults. Serum or plasma, but not venepuncture whole-blood or fingerstick/capillary, are usually used to quantify TSH accurately. Studies on performance evaluation of TSH-LFIAs POCT using venepuncture or fingerstick whole-blood are limited. Additionally, limited studies evaluated the performance and validity of TSH-LFIAs POCT compared to valid and reliable reference methods. To our knowledge, this is the first study to evaluate three different blood withdrawal techniques for evaluating POCT of TSH. Aim: We aim to evaluate the performance of a new fluorescence-based LFIA and its Finecare™ fluorescent reader for quantitative measurement of TSH from a fingerstick, venepuncture whole-blood, and serum. Methods: 102 fingerstick, venepuncture whole-blood, and serum samples (with normal and abnormal TSH values) were analyzed by Finecare™ Rapid Quantitative LFIA test and Roche CobasPro-c503 as a reference test. Results: Using serum, when compared to CobasPro-c503 reference method, Finecare™ showed high sensitivity [90.5 % (69.6-98.8)] and specificity [96.3 % (89.6-99.2)] for diagnosis of thyroid abnormalities (<0.35 or >4.5 mIU/L). The actual test values (mIU/L) of Finecare™ showed excellent agreement (Cohen's Kappa = 0.85) and strong correlation (r = 0.93, p < 0.0001) with CobasPro-c503. Using venepuncture whole-blood samples, Finecare™ showed similar results to serum with high sensitivity [95.2 % (76.2-99.9)], specificity [97.5 % (91.4-99.7)], excellent agreement (Cohen's Kappa = 0.91), and very strong correlation (r = 0.95, p < 0.0001) with CobasPro-c503. These results suggest that Finecare™ can be used for quantitative measurement of TSH using serum or venepuncture whole-blood. These key performance indicators were slightly decreased when fingerstick whole-blood samples were used: sensitivity [85.7 %(63.7-97)], specificity [90.0 %,(81.5-96)], good agreement (Cohen's Kappa = 0.7) and very strong correlation (r = 0.9, p < 0.0001) with CobasPro-c503. A subgroup analysis of abnormal TSH samples revealed a strong and significant correlation between the reference, Finecare™ whole-blood (r = 0.692; p = 0.0015), and fingerstick test Finecare™ (r = 0.66; p = 0.0025). A very strong correlation was also observed between Cobaspro-c508 serum and Finecare™ serum (r = 0.88; p < 0.0001). Conclusion: In comparison to the reference assay, our study demonstrates that Finecare™ exhibits high sensitivity, specificity, agreement, and a strong correlation. These findings provide evidence that Finecare™ is a reliable, valid, and accurate point-of-care test for TSH screening and quantitative measurement, especially in non- or small laboratory settings.

AND/ASPEN and the GLIM malnutrition diagnostic criteria have a high degree of criterion validity and reliability for the identification of malnutrition in a hospital setting: A single-center prospective study.

BACKGROUND: Multiple malnutrition diagnostic tools are available in clinical practice, yet, evidence on their validity and reliability is limited. We aim to assess and compare the validity and reliability of the different combinations of indicators of the three most used diagnostic tools with two validated malnutrition screening tools. METHODS: Nutrition risk screening was evaluated using the Mini Nutritional Assessment-Short Form (MNA-SF) and the Nutrition Risk Screening-2002 (NRS-2002). Nutrition assessment was conducted using different combinations of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (AND/ASPEN), the European Society for Clinical Nutrition and Metabolism (ESPEN), and the Global Leadership Initiative on Malnutrition (GLIM) criteria. Concurrent criterion validity and inter-rater reliability of the overall and the different combinations of indicators in the diagnostic tools were evaluated and compared. Sensitivity, specificity, positive predictive value, negative predictive value, and Cohen kappa were calculated to determine tool validity and reliability. RESULTS: The AND/ASPEN (132 [22.8%]) combination and GLIM-1 (133 [23.0%]) (weight loss + compromised food intake) predicted the highest number of malnourished patients and reported a high degree of concurrent criterion validity, agreement, and reliability. On the contrary, overall ESPEN (using any combination) and GLIM-2 (reduced body mass index [BMI] + compromised food intake) reported only moderate criterion validity and low agreement and reliability. CONCLUSION: Different combinations of diagnostic criteria led to varying validity and reliability, with the lowest validation results rising from the combinations of indicators using BMI as a criterion for malnutrition diagnosis.

Dietary Application for the Management of Patients with Hemodialysis: A Formative Development Study.

OBJECTIVES: To describe the step-by-step person-centered, theory-based development of the KELA.AE app for Arabic speaking hemodialysis patients. METHODS: A step-by-step person-driven theory-based approach was conducted to develop a self-monitoring and educational dietary app for hemodialysis patients. The development follows the Integration, Design, Assessment, and Sharing (IDEAS) framework. Qualitative, semi-structured interviews with 6 hemodialysis patients and 6 healthcare practitioners (dietitians and nephrologists) were performed to assess the need for an app, the willingness to use an app, and features desired in an app. RESULTS: The KELA.AE app, which includes a self-monitoring feature, CKD-friendly recipes, and a theory-based, evidence-based educational feature was developed. Qualitative analysis of interviews revealed two predominant themes from patient interviews 'Experience with the diet', 'App evaluation', and one theme from interviews with healthcare practitioners 'App evaluation'. Patients expressed frustration with current accessibility of dietary information along with the need for educational materials in the app. The review of the KELA.AE prototype was positive overall, and patients reported a willingness to use the app. Healthcare practitioners considered the app accurate, simple, and culturally sensitive but expressed concerns about app misuse and the replacement of healthcare practitioners. CONCLUSIONS: The KELA.AE app was found to be satisfactory and supportive of the participants' needs. Changes were made to the app as suggested during the interviews.