Reference ranges for serum total and monomeric prolactin for the current generation Abbott Architect assay.

BACKGROUND: Exclusion of macroprolactinaemia, a well-recognised interference, as the cause of hyperprolactinaemia is essential to avoid potential misdiagnosis and mismanagement of patients. We have derived gender-specific serum total and post-polyethylene glycol (PEG) precipitation monomeric reference ranges for the recently re-standardised Abbott Architect prolactin assay. METHODS: Prolactin was measured in serum samples obtained from males (n=49) and females (n=52) using the current Abbott Architect immunoassay pre- and post-PEG precipitation. Gender-specific reference ranges were derived for total and monomeric (post-PEG) prolactin. Routine patients' samples (n=175) with a serum total prolactin >700 mIU/L were screened for macroprolactinaemia to assess classification compared with our previous post-PEG precipitation percentage recovery-based approach. RESULTS: Reference ranges for serum total prolactin were 58-419 mIU/L (male) and 63-561 mIU/L (female). Male and female monomeric prolactin reference ranges were 32-309 mIU/L and 39-422 mIU/L, respectively. Mean (SD) post-PEG percentage recovery of the IS 84/500 prolactin standard was 80 (2.3)%. Of 175 patients' samples screened for macroprolactinaemia, 149 had monomeric prolactin concentrations (median monomeric prolactin=1035 mIU/L; median recovery=83%) above the gender-specific reference range. Monomeric prolactin concentrations (median monomeric prolactin=162 mIU/L; median recovery=20%) in the remaining 26 were within the reference ranges. One patient classified as macroprolactin positive and another classified as macroprolactin negative would not have been identified as such using the previous recovery-based approach. CONCLUSIONS: The use of post-PEG monomeric reference ranges not only identifies hyperprolactinaemia due solely to macroprolactinaemia but has the added advantage of identifying patients who have simultaneous true monomeric hyperprolactinaemia and elevated concentrations of macroprolactin.

Rollout of Xpert(®) MTB/RIF in Northwest Cambodia for the diagnosis of tuberculosis among PLHA.

OBJECTIVE: To describe the implementation and utilization of the Xpert (®) MTB/RIF (Xpert) assay to diagnose tuberculosis (TB) among people living with the human immunodeficiency virus/acquired immune-deficiency syndrome (HIV/AIDS, PLHA) in Cambodia. DESIGN: Following the rollout of Xpert, an evaluation was conducted in four provinces of Cambodia from March to December 2012 to determine the utilization, performance, and turnaround time (TAT) of Xpert among PLHA. Data were collected from paper-based patient registers. RESULTS: Of 497 PLHA with a positive TB symptom screen, 357 (72%) were tested with smear microscopy, and 250 (50%) with Xpert; 25 (10%) PLHA tested with Xpert were positive for TB and none were rifampicin-resistant. The utilization of Xpert increased from 23% to 75%, with a median TAT of 1 day. Across districts, utilization ranged from zero to 85%, while the TAT ranged from zero to 22 days. CONCLUSION: While early data show increasing utilization of Xpert for PLHA with a positive symptom screen, most patients underwent smear microscopy as an initial diagnostic test. Training delays and challenges associated with specimen referral may have contributed to variability in Xpert uptake and TAT, particularly for sites without onsite Xpert testing. Enhanced programmatic support, particularly for specimen referral and results reporting, may facilitate appropriate utilization.

Objectif : Décrire la mise en œuvre et l'utilisation du test Xpert(R) MTB/RIF afin de diagnostiquer la tuberculose (TB) parmi des personnes vivant avec le VIH/SIDA (virus de l'mmunodéficience humaine/syndrome de l'immunodéficience acquise ; PLHA) au Cambodge.Schéma : Après le déploiement du test Xpert, une évaluation a été réalisée dans quatre provinces du Cambodge entre mars et décembre 2012 afin de déterminer l'utilisation, la performance et le délai d'exécution du Xpert parmi les PLHA. Des données ont été recueillies à partir des dossiers papiers des patients.Résultats : Sur 497 PLHA ayant une grille de symptômes de TB positive, 357 (72%) ont bénéficié d'une microscopie de frottis et 250 (50%) ont eu un test Xpert ; 25 (10%) PLHA testés par Xpert étaient positifs pour la TB et aucun n'était résistant à la rifampicine. L'utilisation du Xpert est passée de 23% à 75% avec un délai d'exécution médian d'un jour. Dans les districts, l'utilisation allait de zéro à 85% et le délai de mise en œuvre allait de zéro à 22 jours.Conclusion : Si les données précoces montrent une utilisation croissante du Xpert chez les PLHA avec une grille de symptômes positive, la majorité des patients bénéficiait initialement d'un diagnostic par examen microscopique de frottis. Les délais de formation et les problèmes posés par l'envoi des spécimens peuvent avoir contribué à la variabilité du recours au Xpert et au délai de sa mise en œuvre, particulièrement dans les endroits dépourvus de possibilité de test Xpert sur place. Davantage de soutien aux programmes, notamment en termes d'envoi des spécimens et de retour des résultats, pourrait faciliter son utilisation appropriée.

Objetivo: Describir la introducción y la utilización de la prueba Xpert(R) MTB/RIF en el diagnóstico de la tuberculosis (TB) de las personas aquejadas de infección por el virus de la inmunodeficiencia humana (VIH) y sida (PLHA) en Camboya.Método: Tras el despliegue de Xpert, se llevó a cabo una evaluación en cuatro provincias de Camboya de marzo a diciembre del 2012 con el fin de determinar el tipo de utilización, el rendimiento diagnóstico y el tiempo de obtención de los resultados de la prueba Xpert en las PLHA. Se recogieron los datos de los pacientes a partir de los registros en soporte de papel.Resultados: De los 497 PLHA y una detección positiva de síntomas de la TB, en 357 casos se practicó una baciloscopia (72%) y en 250 la Xpert (50%); 25 de las personas examinadas con Xpert obtuvieron un resultado positivo (10%) y en ninguna se observó resistencia a rifampicina. La utilización de la prueba aumentó de 23% a 75% y la mediana del lapso hasta obtener el resultado fue un día. En los diferentes distritos, el uso de la prueba osciló entre 0% y 85% y el lapso hasta la notificación del resultado fue de cero a 22 días.Conclusión: Los datos iniciales indicaron un aumento de la utilización de la prueba Xpert en las PLHA que presentan una detección positiva de síntomas de la TB, pero en la mayoría de los pacientes se practicó la baciloscopia del esputo como prueba diagnóstica inicial. Es posible que los retrasos en la capacitación y las dificultades relacionadas con la remisión de las muestras hayan contribuido a la variabilidad en la aceptación de la Xpert y en el tiempo de obtención de los resultados, sobre todo en los centros donde no se practica la prueba en el lugar de atención. Se podría fomentar el uso apropiado de esta prueba mediante un apoyo programático, dirigido especialmente a la remisión de las muestras y la notificación de los resultados.

Unexpectedly high HIV prevalence among female sex workers in Bangkok, Thailand in a respondent-driven sampling survey.

The pattern of sex work in Thailand has shifted substantially over the last two decades from direct commercial establishments to indirect venues and non-venue-based settings. This respondent-driven sampling survey was conducted in Bangkok in 2007 among female sex workers (FSW) in non-venue-based settings to pilot a new approach to surveillance among this hidden population. Fifteen initial participants recruited 707 consenting participants who completed a behavioural questionnaire, and provided oral fluid for HIV testing, and urine for sexually transmitted infection (STI) testing. Overall HIV prevalence was 20.2% (95% confidence interval [CI] 16.3-24.7). Three-quarters of women were street-based (75.8%, 95% CI 69.9-81.1) who had an especially high HIV prevalence (22.7%, 95% CI 18.2-28.4); about 10 times higher than that found in routine sentinel surveillance among venue-based FSW (2.5%). STI prevalence (Chlamydia trachomatis and Neisseria gonorrhoeae) was 8.7% (95% CI 6.4-10.8) and 1.0% (95% CI 0.2-1.9), respectively. Lower price per sex act and a current STI infection were independently associated with HIV infection (P < 0.05). High HIV prevalence found among FSW participating in the survey, particularly non-venue-based FSW, identifies need for further prevention efforts. In addition, it identifies a higher-risk segment of FSW not reached through routine sentinel surveillance but accessible through this survey method.

Between-assay variability of faecal calprotectin enzyme-linked immunosorbent assay kits.

BACKGROUND: Faecal calprotectin (f-Cp), a marker of intestinal inflammation, can be used to distinguish between functional and organic bowel disease. F-Cp, following extraction, is commonly quantified using enzyme-linked immunosorbent assays (ELISAs) but there are no data comparing the different f-Cp assays or sample extraction devices. We, therefore, evaluated and compared the performance of the Immunodiagnostik, Bühlmann and Eurospital f-Cp ELISA assays as well as the Roche, Immunodiagnostik and ScheBo Biotech commercial faecal extraction devices. We also briefly report results from a pilot f-Cp external quality assurance (EQA) scheme. METHODS: Imprecision, linearity, recovery, drift and limit of quantitation of the f-Cp assays were evaluated and between-assay variability assessed. The three commercial sample extraction devices were compared with the manual weighing method. Four faecal samples were distributed as part of a pilot EQA scheme to 15 laboratories using quantitative ELISA f-Cp assays. RESULTS: The three f-Cp assays demonstrated adequate intra-/interbatch imprecision, linearity and recovery. The cross-comparison study and EQA data demonstrated that, for the same sample, the Bühlmann assay reports up to 3.8 times higher f-Cp concentrations than the Immunodiagnostik and Eurospital assays. On average, the commercial extraction devices led to a 7.8-28.1% under-recovery of f-Cp in comparison to the manual weighing method. CONCLUSIONS: Laboratories should be aware of the lack of the assay standardization, as demonstrated by the between-assay variability. A comparison between f-Cp concentrations reported by these assays and clinical markers of disease severity is required in order to determine their diagnostic accuracy. The EQA scheme represents the first available programme for f-Cp.

HIV-1 and herpes simplex virus type-2 genital shedding among co-infected women using self-collected swabs in Chiang Rai, Thailand.

We analysed 528 genital self-collected swabs (SCS) from 67 HIV-1 and herpes simplex virus type-2 (HSV-2) co-infected women collected during the placebo month of a randomized crossover clinical trial of suppressive acyclovir in Chiang Rai, Thailand. In this first longitudinal study of HIV-1 and HSV-2 co-infected women using genital SCS specimens, we found frequent mucosal HIV-1 shedding. Overall, 372 (70%) swabs had detectable HIV-1 RNA with median HIV-1 viral load of 2.61 log(10) copies/swab. We found no statistically significant association between detectable HIV-1 RNA and HSV-2 DNA in the same SCS specimen (adjusted odds ratio [aOR] 1.40; 95% confidence intervals [CI], 0.78-2.60, P = 0.25). Only baseline HIV-1 plasma viral load was independently associated with genital HIV-1 RNA shedding (aOR, 7.6; 95% CI, 3.3-17.2, P < 0.0001). SCS may be useful for future HIV-1 and HSV-2 studies because this method allows for frequent genital sampling, and inclusion of genital sites other than the cervix.

Improving surveillance for maternal and perinatal health in 2 districts of rural Tanzania.

OBJECTIVES: As part of a community-based reproductive health project in rural Tanzania, a maternal and perinatal health care surveillance system was established to monitor pregnancy outcomes. This report presents preliminary results. METHODS: Village health workers were trained to collect data during health education visits to pregnant and postpartum women. Maternal and fetal or infant survival or deaths were tracked on a community monitoring board. RESULTS: Among 904 pregnancies, the fetoneonatal mortality rate was 69.4 deaths per 1000 live births and fetal deaths; 4 maternal deaths occurred. Intrapartum and early neonatal deaths of infants with birthweights of 1500 g or greater represented a large proportion of deaths. CONCLUSIONS: These preliminary results will be used to prioritize project interventions, including increasing access to skilled delivery care.