Clinical severity of enteric viruses detected using a quantitative molecular assay compared to conventional assays in the Global Enteric Multicenter Study.

BACKGROUND: Quantitative molecular assays are increasingly used for detection of enteric viruses. METHODS: We compared the clinical severity using modified Vesikari score (mVS) of enteric viruses detected by conventional assays (enzyme immunoassays [EIA] for rotavirus and adenovirus 40/41 and conventional polymerase chain reaction for astrovirus, sapovirus, and norovirus) and a quantitative molecular assay (TaqMan Array Card [TAC]) among children aged 0-59 months in the Global Enteric Multicenter Study. For rotavirus and adenovirus 40/41, we compared severity between EIA-positive and TAC-positive cases assigned etiologies using different cycle threshold (CT) cutoffs. RESULTS: Using conventional assays, the median (interquartile range) mVS was 10 (8, 11) for rotavirus, 9 (7, 11) for adenovirus 40/41, 8 (6, 10) for astrovirus, sapovirus, and norovirus GII, and 7 (6, 9) for norovirus GI. Compared to rotavirus EIA-positive cases, the median mVS was 2 and 3 points lower for EIA-negative/TAC-positive cases with CT<32.6 and 32.6≤CT<35, respectively (p-value<.0001). Adenovirus 40/41 EIA-positive and EIA-negative/TAC-positive cases were similar, regardless of CT cutoff. CONCLUSIONS: Quantitative molecular assays compared to conventional assays, such as EIA, may influence severity of identified cases, especially for rotavirus. Cutoffs to assign etiology for quantitative assays should be considered in the design and interpretation of enteric virus studies.

Young infant clinical signs study--, Pakistan: a data note.

Neonatal sepsis is the leading cause of child death globally with most of these deaths occurring in the first week of life. It is of utmost public health importance that clinical signs predictive of severe illness and need for referral are identified early in the course of illness. From 2002-2005, a multi country trial called the Young Infant Clinical Signs Study (YICSS) was conducted in seven sites across three South-Asian (Bangladesh, India, and Pakistan), two African (Ghana, and South Africa), and one South American (Bolivia) country. The study aimed to develop a simplified algorithm to be used by primary healthcare workers for the identification of sick young infants needing prompt referral and treatment. The main study enrolled 8,889 young infants between the ages of 0-59 days old. This dataset contains observations on 2950 young infants aged 0-59 days from the Pakistan site. The data was collected between 2003-2004 with information on the most prevalent signs and symptoms. The data from this study was used to update the Integrated Management of Childhood Illness guidelines. The World Health Organisation (WHO) seven-sign algorithm has been used in other major community-based trials to study possible serious bacterial infection and its treatment regimens.