| 1. |
- Andreasson, Ulf, 1968, et al.
(författare)
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A Practical Guide to Immunoassay Method Validation.
- 2015
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Ingår i: Frontiers in neurology. - : Frontiers Media SA. - 1664-2295. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Biochemical markers have a central position in the diagnosis and management of patients in clinical medicine, and also in clinical research and drug development, also for brain disorders, such as Alzheimer's disease. The enzyme-linked immunosorbent assay (ELISA) is frequently used for measurement of low-abundance biomarkers. However, the quality of ELISA methods varies, which may introduce both systematic and random errors. This urges the need for more rigorous control of assay performance, regardless of its use in a research setting, in clinical routine, or drug development. The aim of a method validation is to present objective evidence that a method fulfills the requirements for its intended use. Although much has been published on which parameters to investigate in a method validation, less is available on a detailed level on how to perform the corresponding experiments. To remedy this, standard operating procedures (SOPs) with step-by-step instructions for a number of different validation parameters is included in the present work together with a validation report template, which allow for a well-ordered presentation of the results. Even though the SOPs were developed with the intended use for immunochemical methods and to be used for multicenter evaluations, most of them are generic and can be used for other technologies as well.
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| 2. |
- Kruse, Anne R., et al.
(författare)
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Breastfeeding among parous women offered home-visit by a midwife after early discharge following planned cesarean section : Secondary analysis of a randomized controlled trial
- 2023
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Ingår i: European Journal of Midwifery. - 2585-2906. ; 7:December
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION Early discharge holds several advantages and seems safe after planned cesarean section among low-risk women. However, breastfeeding rates are lower after cesarean section. Thus, concern has been raised that early discharge among these women may affect breastfeeding even further. Therefore, we aimed to assess the effect of early discharge the day after planned cesarean section on breastfeeding, among parous women when a home-visit by a midwife was provided the day after discharge. METHODS We conducted a secondary analysis of a randomized trial. Parous women (n=143) planned for cesarean section were allocated to either discharge within 28 hours after planned cesarean section followed by a home visit the day after (early discharge) or discharge at least 48 hours after planned cesarean section (standard care). The participants filled in questionnaires approximately 2 weeks before delivery and 1 week, 4 weeks, and 6 months postpartum. RESULTS The proportions of women initiating breastfeeding were 84% versus 87% (early discharge vs standard care). After 6 months, 23% versus 21% were exclusively breastfeeding, while 29% versus 42% were partially breastfeeding. The mean duration of exclusive breastfeeding was 3.4 months (SD=2.3) in both groups. None of these differences was statistically significant. In both groups, the women’s breastfeeding selfefficacy score before cesarean section correlated with the duration of breastfeeding. After 4 weeks, low-score rates were 28% versus 30%. CONCLUSIONS Early discharge with follow-up home visits by a midwife after planned cesarean section in parous women is feasible without compromising breastfeeding.
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| 3. |
- Kruse, Anne R., et al.
(författare)
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Effect of early discharge after planned cesarean section on recovery and parental sense of security. A randomized clinical trial
- 2021
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 100:5, s. 955-963
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: In some European countries, discharge the day after planned cesarean section has become an accepted procedure. However, little is known about the patients’ perception of early discharge. The aim of this study was to compare early discharge with standard care in relation to parental sense of security. Further, we evaluated postoperative pain, mobilization, and readmission. Material and methods: We performed a randomized clinical trial including parous, singleton pregnant women with a planned cesarean section at term. The women were allocated to either discharge within 28 hours (intervention group) or after 48 hours (standard care group) following the cesarean section. Women discharged within 28 hours after cesarean section were offered a home visit by a midwife the following day. The primary outcome was the postnatal sense of security, which was reported by the woman and her partner in the “Parents’ Postnatal Sense of Security” questionnaire 1 week postpartum. Secondary outcomes were pain score, use of analgesics, mobilization, readmission, and contacts with the healthcare system in the postoperative period. Results: We included 143 women, of whom 72 were allocated to the intervention group and 71 were allocated to the standard care group. There were no differences in baseline characteristics. The two groups did not differ concerning the postnatal sense of security for the women (P =.98) or the postnatal sense of security for the partners (P =.38). We found no difference in pain scores, step count, use of analgesics, or number of contacts with the health-care system between the groups. Conclusions: Parental postnatal sense of security is not compromised by discharge within 28 hours followed by a home visit compared with discharge after 48 hours after planned cesarean section among parous women.
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| 4. |
- Mollenhauer, Brit, et al.
(författare)
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Antibody-based methods for the measurement of α-synuclein concentration in human cerebrospinal fluid - method comparison and round robin study.
- 2019
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Ingår i: Journal of neurochemistry. - : Wiley. - 1471-4159 .- 0022-3042. ; 149:1, s. 126-138
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Tidskriftsartikel (refereegranskat)abstract
- α-Synuclein is the major component of Lewy bodies and a candidate biomarker for neurodegenerative diseases in which Lewy bodies are common, including Parkinson's disease and dementia with Lewy bodies. A large body of literature suggests that these disorders are characterized by reduced concentrations of α-synuclein in cerebrospinal fluid (CSF), with overlapping concentrations compared to healthy controls and variability across studies. Several reasons can account for this variability, including technical ones, such as inter-assay and inter-laboratory variation (reproducibility). We compared four immunochemical methods for the quantification of α-synuclein concentration in 50 unique CSF samples. All methods were designed to capture most of the existing α-synuclein forms in CSF ('total' α-synuclein). Each of the four methods showed high analytical precision, excellent correlation between laboratories (R2 0.83-0.99), and good correlation with each other (R2 0.64-0.93), although the slopes of the regression lines were different between the four immunoassays. The use of common reference CSF samples decreased the differences in α-synuclein concentration between detection methods and technologies. Pilot data on an immunoprecipitation mass spectrometry (IP-MS) method isalso presented. Our results suggest that the four immunochemical methods and the IP-MS method measure similarforms of α-synuclein and that a common reference materialwould allow harmonization of results between immunoassays.
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