Dried blood spot HIV-1 RNA quantification: a useful tool for viral load monitoring among HIV-infected individuals in India.

BACKGROUND & OBJECTIVES: Monitoring of HIV-infected individuals on antiretroviral treatment (ART) ideally requires periodic viral load measurements to ascertain adequate response to treatment. While plasma viral load monitoring is widely available in high-income settings, it is rarely used in resource-limited regions because of high cost and need for sophisticated sample transport. Dried blood spot (DBS) as source specimens for viral load measurement has shown promise as an alternative to plasma specimens and is likely to be a useful tool for Indian settings. The present study was undertaken to investigate the performance of DBS in HIV-1 RNA quantification against the standard plasma viral load assay. METHODS: Between April-June 2011, 130 samples were collected from HIV-1-infected (n=125) and non-infected (n=5) individuals in two district clinics in southern India. HIV-1 RNA quantification was performed from DBS and plasma using Abbott m2000rt system after manual RNA extraction. Statistical analysis included correlation, regression and Bland-Altman analysis. RESULTS: The sensitivity of DBS viral load was 97 per cent with viral loads >3.0 log 10 copies/ml. Measurable viral load (>3.0 log 10 copies/ml) results obtained for the 74 paired plasma-DBS samples showed positive correlation between both the assays (r=0.96). For clinically acceptable viral load threshold values of >5,000 copies/ml, Bland-Altman plots showed acceptable limits of agreement (-0.21 to +0.8 log 10 copies/ml). The mean difference was 0.29 log 10 copies/ml. The cost of DBS was $2.67 lower compared to conventional plasma viral load measurement in the setting. INTERPRETATION & CONCLUSIONS: The significant positive correlation with standard plasma-based assay and lower cost of DBS viral load monitoring suggest that DBS sampling can be a feasible and economical means of viral load monitoring in HIV-infected individual in India and in other resource-limited settings globally.

Bypassing health facilities for childbirth: a multilevel study in three districts of Gujarat, India.

BACKGROUND: Bypassing available facilities for childbirth has important implications for maternal health service delivery and human resources within a health system. The results are the additional expenses imposed on the woman and her family, as well as the inefficient use of health system resources. Bypassing often indicates a lack of confidence in the care provided by the facility nearest to the mother, which implies a level of dysfunctionality that the health system needs to address. Over the past decade, India has experienced a steep rise in the proportion of facility births. The initiation of programs promoting facility births resulted in a rise from 39% in 2005 to 85% in 2014. There have been no reports on bypassing facilities for childbirth from India. In the context of steeply rising facility births, it is important to quantify the occurrence of and study the relative contributions of maternal characteristics and facility functionality to bypassing. OBJECTIVES: 1) To determine the extent of bypassing health facilities for childbirth among rural mothers in three districts of Gujarat, India, 2) to identify associations between the functionality of an obstetric care (OC) facility and it being bypassed, and 3) to assess the relative contribution of maternal and facility characteristics to bypassing. DESIGN: A cross-sectional survey of 166 public and private OC facilities reporting ≥30 births in the 3 months before the survey was conducted in three purposively selected districts (Dahod, Sabarkantha, and Surendranagar) in the state of Gujarat, India. Besides information on each facility, data from 946 women giving birth at these facilities were also gathered. Data were analyzed using a multilevel mixed-effects logistic regression model. RESULTS: Off all mothers, 37.7% bypassed their nearest facility for childbirth. After adjusting for maternal characteristics, for every one-unit increase in the facility's emergency obstetric care (EmOC) signal functions, the odds of bypassing a facility for childbirth decreased by 37% (adjusted odds ratio [AOR] 0.63, 95% confidence interval [CI]: 0.53-0.76). CONCLUSIONS: This study shows that independent of maternal characteristics, in our setting, women will bypass obstetric facilities that are not adequately functional, and travel further to others that are more functional. It is important that the health system should focus on facility functionality, especially in the context of sharply rising hospital births.

Evaluation of the Xpert® MTB/Rif test, microscopic observation drug susceptibility test and nitrate reductase assay, for rapid and accurate diagnosis of smear-negative tuberculosis in HIV patients.

Diagnosis of smear-negative tuberculosis (TB), which is frequently seen in HIV-infected patients, is a challenge without conventional culture methods. Since 2007, the WHO (World Health Organization) has endorsed new or improved tests for increased and rapid diagnosis of TB. This study was undertaken in an effort to evaluate the accuracy of two rapid culture methods: the Microscopic Observation Drug Susceptibility assay (MODS) and Nitrate Reductase Assay (NRA), and the molecular based test Xpert® MTB/Rif (Xpert), for diagnosis of smear-negative TB in HIV patients using the mycobacteria growth indicator tube (MGIT) in the BACTEC(TM) MGIT(TM) 960 system as the reference test. 430 smear-negative patients with presumptive TB were enrolled in a cross-sectional study at a tertiary care facility in Uganda. Their sputum was tested on MODS, NRA, Xpert and MGIT. Of the 430 patients, 373 had complete results to compute test accuracy. Mycobacterium tuberculosis (MTB) was detected in 43 patients by MGIT. The sensitivity and specificity were 24.4% and 98.1% for MODS, 41.5% and 92% for NRA, 48.8% and 95.1% for Xpert, respectively. The low sensitivity of the tests implies that additional diagnostics such as chest X-ray and conventional liquid culture methods might still be needed to detect TB in smear-negative HIV patients. The high specificity of the tests is useful to confirm TB in HIV patients with symptoms suggestive of TB.