ABSTRACT
Antepartum fetal surveillance (AFS) is essential for pregnant women with diabetes to mitigate the risk of stillbirth. However, there is still no universal consensus on the optimal testing method, testing frequency, and delivery timing. This review aims to comprehensively analyze the evidence concerning AFS and the most advantageous timing for delivery in both gestational and pregestational diabetes mellitus cases. This review's methodology involved an extensive literature search encompassing international diabetes guidelines and scientific databases, including PubMed, MEDLINE, Google Scholar, and Scopus. The review process meticulously identified and utilized pertinent articles for analysis. Within the scope of this review, a thorough examination revealed five prominent international guidelines predominantly addressing gestational diabetes. These guidelines discuss the utility and timing of fetal well-being assessments and recommendations for optimal pregnancy resolution timing. However, the scarcity of clinical trials directly focused on this subject led to a reliance on observational studies as the basis for most recommendations. Glucose control, maternal comorbidities, and the medical management received are crucial in making decisions regarding AFS and determining the appropriate delivery timing.
ABSTRACT
Background: RT-PCR is the currently recommended laboratory method for diagnosing acute SARS-CoV-2 infection. Nevertheless, to carry out this assay, numerous manual steps are necessary, but they are long lasting and error-prone. A new sample preparation solution was launched, the Qiaprep & amp Viral RNA UM kit, that combines a short, liquid-based sample preparation with one-step RT-PCR amplification and detection of SARS-CoV-2. Such alternative allows reducing the handling of samples and obtaining a result in a shorter period of time. The objective of the study was to compare the performance of the kit with RT-PCR. Methods: A prospective trial was carried out in the clinical microbiology laboratory of a tertiary care hospital. The pharyngeal and nasopharyngeal swabs included in the study were taken from patients who underwent medical consultation because compatible COVID-19 symptoms. Samples were processed simultaneously for the reference RT-PCR and by the QIA P&A kit. Results: 190 samples were included in the clinical trial. The reference RT-PCR method indicated that 125 (66%) samples, out of the 190, were positive. The QIA P&A kit showed 112 positive samples for SARS-CoV-2. The QIA P&A kit has a sensitivity of 86% to detect SARS-CoV-2 and a 100% specificity, the positive predictive value was of 96%, the negative predictive value 78%, and the obtained Kappa value was 0,76. QIA P&A kit showed a lower mean cycle threshold compared with the diagnostic standard, with a statistically significant difference (p < 0.05). Conclusion: The QIA P&A kit has an acceptable, yet not optimal performance for sample preparation and amplification of SARS-CoV-2 and further studying is required for it to be validated as a cost-effective, rapid diagnostic method for detecting infections.
