Background & aim Screening for genital infection (GI) such as bacterial vaginosis (BV) and yeast infection, for sexually transmitted infection (STI), and for asymptomatic carriage of group B streptococcus (GBS) in pregnant women are common reason for medical appointments. The diagnosis and control of GIs, STIs, and GBS are major issues, for fertility and overall well-being of affected women. Conventional testing is performed using vaginal/cervical classical sampling (VCS); this procedure requires pelvic examination performed by health care professionals which raises concerns among women. Vaginal-self-sampling (VSS), as an alternative to VCS, might capture more women. The aim was first to show non-inferiority of VSS compared with VCS to screen for GIs, STIs, and GBS; second to determine the feasibility of VSS. Methods VSS and VCS from 1027 women were collected by health care professionals and simultaneously carried out on each patient. GIs, STIs, and GBS were systematically screened in both paired VSS and VCS samples. Non-inferiority of VSS compared with VCS was assessed using z statistic for binomial proportions. Results Prevalence of GIs were 39.7% using VSS and 38.1% using VCS (p = 0.0016). Prevalence of STIs was 8.5% (VSS) vs 8.1% (VCS) (p = 0.0087). Prevalence of GBS was 13.4% (VSS) and 11.5% (VCS) (p = 0.0001). Most participants (84%) recommended the use of VSS. Conclusions This study shows that VSS was not inferior to VCS for the detection of GIs, STIs, and GBS. This study provides evidence that VSS can be used as a universal specimen for detection of lower genital tract infections in women. Study identification number ID-RCB 2014-A01250-4.

IntroductionRapid detection of abnormal biological values using point-of-care (POC) testing allows clinicians to promptly initiate therapy; however, there are concerns regarding the reliability of POC measurements. We investigated the agreement between the latest generation blood gas analyzer and central laboratory measurements of electrolytes, bicarbonate, hemoglobin, hematocrit, and glucose.Methods314 paired samples were collected prospectively from 51 critically ill patients. All samples were drawn simultaneously in the morning from an arterial line. BD Vacutainer tubes were analyzed in the central laboratory using Beckman Coulter analyzers (AU 5800 and DxH 800). BD Preset 3 ml heparinized-syringes were analyzed immediately in the ICU using the POC Siemens RAPIDPoint 500 blood gas system. We used CLIA proficiency testing criteria to define acceptable analytical performance and interchangeability.ResultsBiases, limits of agreement (±1.96 SD) and coefficients of correlation were respectively: 1.3 (-2.2 to 4.8 mmol/L, r = 0.936) for sodium; 0.2 (-0.2 to 0.6 mmol/L, r = 0.944) for potassium; -0.9 (-3.7 to 2 mmol/L, r = 0.967) for chloride; 0.8 (-1.9 to 3.4 mmol/L, r = 0.968) for bicarbonate; -11 (-30 to 9 mg/dL, r = 0.972) for glucose; -0.8 (-1.4 to -0.2 g/dL, r = 0.985) for hemoglobin; and -1.1 (-2.9 to 0.7%, r = 0.981) for hematocrit. All differences were below CLIA cut-off values, except for hemoglobin.ConclusionsCompared to central Laboratory analyzers, the POC Siemens RAPIDPoint 500 blood gas system satisfied the CLIA criteria of interchangeability for all tested parameters, except for hemoglobin. These results are warranted for our own procedures and devices. Bearing these restrictions, we recommend clinicians to initiate an appropriate therapy based on POC testing without awaiting a control measurement.

ObjectiveScreening for genital infection (GI), bacterial vaginosis (BV), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Objectives were first to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling to screen for GIs, bacterial vaginosis (BV), STIs, and GBS asymptomatic carriage in pregnant women; second to determine the feasibility of vaginal self-sampling.MethodsVaginal self-sampling (VSS) and vaginal/cervical classical sampling (VCS) of 1027 women were collected by health care professionals and simultaneously carried out on each patient. Bacterial infection, yeast infection, Chlamydia trachomatis, Neisseria gonorrhoea, Mycoplasma genitalium, Trichomonas vaginalis and Herpes simplex virus types were systematically screened in both paired VSS and VCS samples.ResultsStatistical tests supported the non-inferiority of VSS compared with VCS. Agreements between VCS and VSS remained high regardless of the type of studied infection. VSS had successful diagnostic performances, especially for Predictive negative value (PNV) (over 90%) for all studied infections. Most participants (84%) recommended the use of VSS.ConclusionsThis study remains the most exhaustive in screening for GI, BV, STI agents and asymptomatic GBS carriage. Given its efficacy and acceptability, VSS seems to be a viable alternative to classic physician sampling among women in the general population. This study provides evidence that vaginal self-sampling can be used as a universal specimen for detection of lower genital tract infections in women.Study Identification numberID-RCB 2014-A01250-4