Head-to-head comparison of two loop-mediated isothermal amplification (LAMP) kits for diagnosis of malaria in a non-endemic setting.

BACKGROUND: Light microscopy and rapid diagnostic tests (RDT) have long been the recommended diagnostic methods for malaria. However, in recent years, loop-mediated isothermal amplification (LAMP) techniques have been shown to offer superior performance, in particular concerning low-grade parasitaemia, by delivering higher sensitivity and specificity with low laboratory capacity requirements in little more than an hour. In this study, the diagnostic performance of two LAMP kits were assessed head-to-head, compared to highly sensitive quantitative real time PCR (qPCR), in a non-endemic setting. METHODS: In this retrospective validation study two LAMP kits; Alethia® Illumigene Malaria kit and HumaTurb Loopamp™ Malaria Pan Detection (PDT) kit, were evaluated head-to-head for detection of Plasmodium-DNA in 133 biobanked blood samples from suspected malaria cases at the Clinical Microbiology Laboratory of Region Skåne, Sweden to determine their diagnostic performance compared to qPCR. RESULTS: Of the 133 samples tested, qPCR detected Plasmodium DNA in 41 samples (defined as true positives), and the two LAMP methods detected 41 and 37 of those, respectively. The results from the HumaTurb Loopamp™ Malaria PDT kit were in complete congruence with the qPCR, with a sensitivity of 100% (95% CI 91.40-100%) and specificity of 100% (95% CI 96.07-100%). The Alethia® Illumigene Malaria kit had a sensitivity of 90.24% (95% CI 76.87-97.28) and a specificity of 95.65% (95% CI 89.24-98.80) as compared to qPCR. CONCLUSIONS: This head-to-head comparison showed higher performance indicators of the HumaTurb Loopamp™ Malaria PDT kit compared to the Alethia® illumigene Malaria kit for detection of malaria.

The relationship between physical workload and quality within line-based assembly.

Reducing costs and improvement of product quality are considered important to ensure productivity within a company. Quality deviations during production processes and ergonomics have previously shown to be associated. This study explored the relationship between physical workload and real (found during production processes) and potential (need of extra time and assistance to complete tasks) quality deviations in a line-based assembly plant. The physical workload on and the work rotation between 52 workstations were assessed. As the outcome, real and potential quality deviations were studied during 10 weeks. Results show that workstations with higher physical workload had significantly more real deviations compared to lower workload stations. Static work posture had significantly more potential deviations. Rotation between high and low workload was related to fewer quality deviations compared to rotation between only high workload stations. In conclusion, physical ergonomics seems to be related to real and potential quality deviation within line-based assembly. Practitioner Summary: To ensure good productivity in manufacturing industries, it is important to reduce costs and improve product quality. This study shows that high physical workload is associated with quality deviations and need of extra time and assistance to complete tasks within line-based assembly, which can be financially expensive for a company.

The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients.

BACKGROUND: Self-monitoring of blood glucose is a cornerstone of diabetes management. The aim of this study was to evaluate the analytical quality and the ease of use of the Accu-Chek Mobile, a new glucose monitoring system designed for capillary blood testing by diabetic patients. MATERIALS AND METHODS: The performance of the Accu-Chek Mobile was evaluated both in the hands of a scientist and of diabetes patients. The designated comparative method was a hexokinase-based laboratory method (Architect ci8200). Diabetics (N = 88) with previous experience of self-testing were recruited for the study. Patient samples, containing glucose in concentrations mainly between ˜4 and ˜20 mmol/L, were analyzed in duplicates both on the Accu-Chek Mobile and with the comparative method. The patients answered a questionnaire about the ease of use of the meter. RESULTS: The meter yields reproducible readings, with an imprecision CV <5% as required by the American Diabetes Association (ADA). Of the glucose concentrations obtained by both the scientist and the patients, more than 95% of the individual results were within ± 20% of the comparative method, meeting the ISO 15197 accuracy goal, but not the stricter ± 10% ADA goal. CONCLUSION: Accu-Chek Mobile is a user-friendly glucometer that in a normo- and hyperglycemic range fulfils the ISO 15197 accuracy requirement, also in the hands of diabetes patients.

The evolving role of springs in craniofacial surgery: the first 100 clinical cases.

BACKGROUND: The use of springs in craniofacial surgery originated at Sahlgrenska University Hospital in 1997 as a way of remodeling the cranial vault postoperatively. METHODS: The hospital records of the first 100 operations involving spring placement were analyzed retrospectively. Demographic, perioperative, and postoperative data were recorded. RESULTS: Two hundred forty-six springs were used in 96 patients. Results for sagittal, metopic, bicoronal, multiple synostoses, and midface surgery are presented. In total, five patients (5 percent) required further surgery because of undercorrection. There were no major complications. Spring dislodgement (5 percent) was the most common complication in early cases. Raised intracranial pressure resulted in a protocol change with the use of compressive springs. The data compare favorably with those of standard craniofacial procedures performed in the same unit. CONCLUSIONS: This therapeutic modality in craniofacial surgery has allowed minimization of the extent of surgery without compromising clinical outcomes. Springs have now become part of the authors' treatment protocol for craniosynostosis and midface surgery. The authors have shown the use of these techniques to be safe and, in selected situations, to offer significant advantages over other methods of treatment.

Eclampsia in Scandinavia: incidence, substandard care, and potentially preventable cases.

BACKGROUND: Description of incidence, clinical signs, symptoms, and consequences of eclampsia in Scandinavia, and assessment of substandard care and potential preventability. METHODS: A descriptive cohort study including all women giving birth in a 2-year period (mid-1998-mid-2000) in Scandinavia. Notifications of eclampsia cases were obtained from all obstetric units at 3-monthly intervals. All patient files were reviewed, and systematic audit was performed to identify potentially preventable cases by using predefined criteria. MAIN OUTCOME MEASURES: Signs and symptoms preceding the eclamptic seizure, the standard of medical care, maternal and perinatal morbidity, and mortality were all recorded. Potentially preventable cases through improved care and cases eligible for primary prophylactic magnesium sulfate (MgSO4) were estimated. RESULTS: The incidence of eclampsia was 5.0/10,000 maternities (CI = 4.3-5.7/10,000). Eighty-six percent had a diagnosis of pre-eclampsia before the seizure. Nine of 10 had at least one physical complaint before the first seizure, severe headache being the most common symptom, occurring in two-thirds. Most seizures (90%) occurred after admission to hospital. By audit, 89 cases (42%) were classified as having received substandard care. Prophylactic use of magnesium sulfate might have reduced the number of eclampsia cases by 35 (17%). CONCLUSIONS: Eclampsia occurred mainly in hospital and the majority of women had symptoms heralding the seizure. In retrospect, nearly half of the cases were found potentially preventable by timely intervention, improved medical care, and systematic use of prophylactic treatment with MgSO4.