Diagnostic Accuracy of Human Immunodeficiency Virus In Vitro Assays Evaluated by the World Health Organization Prequalification Evaluation Laboratories: Systematic Review and Meta-Analysis.

To maintain the performance quality, human immunodeficiency virus (HIV) in vitro diagnostic (IVD) kits are required to be evaluated by unbiased health regulatory organizations following predefined guidelines. The World Health Organization (WHO) prequalification is one such program for the evaluation of IVD assays. In the present systematic review and meta-analysis, we analyzed and compared the 17 WHO prequalified public reports of HIV IVDs to yield summarized information for performance parameters. Pooled sensitivity, pooled specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio were used as overall performance evaluation parameters. High (≥98%) and comparable levels of sensitivity and specificity were observed for most of the assays. In addition, the overall diagnostic efficiency was observed to attain high precision, as evident by the value of the area under the curve (AUC) for the hierarchical summary receiver operating characteristic curve (AUC ≥ 0.98).

Performance of commercially available HIV in vitro diagnostic assays: A systematic review and meta-analysis.

Efficient and fast detection of HIV infection is required to make the diagnosis more robust. Use of in vitro HIV diagnostic assays based on different methods are growing rapidly. To maintain quality and further upgradation, regular performance evaluation is required. Due to presence of huge number and types of commercially available kits, choice of implementation varies differentially. The present systematic review and meta-analysis is aimed to address the diagnostic performance of commercially available in vitro HIV assays in terms of pooled sensitivity, specificity, Positive Likelihood Ratio, Negative Likelihood Ratio, area under hierarchical summary receiver operating characteristic curve and diagnostic odds ratios, in global scenario. Total of 18 articles with 35 in vitro diagnostic serological assays including 29,713 samples were subjected for the present pooled analysis. In spite of higher heterogenicity [I2 = 93.5%, Q = 520.95, df = 34 (p = 0.0000), τ2 = 9.7464], the pooled sensitivity and specificity of the diagnostic serological assays were observed ≥ 98%.

Coronavirus (SARS-CoV-2): a systematic review for potential vaccines.

COVID-19 is an international public health emergency in need of effective and safe vaccines for SARS-CoV-2. A systematic review has been done to analyze the availability, development and status of new COVID-19 vaccine candidates as well as the status of vaccines for other diseases that might be effective against SARS-CoV-2 infection. PubMed, MEDLINE, EMBASE, Science Direct, Google Scholar, Cochrane library, ClinicalTrials.gov, Web of Science and different trial registries were searched for currently available and probable future vaccines. Articles and ongoing clinical trials are included to ascertain the availability and developmental approaches of new vaccines that could limit the present and future outbreaks. Pharmaceutical companies and institutions are at different stages of developing new vaccines, and extensive studies and clinical trials are still required.

Mother-to-child HIV transmission and its correlates in India: systematic review and meta-analysis.

BACKGROUND: In India, preventing mother-to-child transmission (PMTCT) of Human Immunodeficiency Virus (HIV) remains one of the foremost challenge in community health. Countrywide MTCT of HIV is estimated to be > 10,000 annually. Aims of present study are to find out the prevalence of HIV and correlates of HIV transmission among children given birth by HIV infected mother through systematic review along with meta-analysis. METHODS: All avaiable articles are retrieved using MEDLINE, Cochrane Library, Science Direct, EMBASE, Google Scholar and PUBMED following guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) are applied to critically reviewing the selected articles. STATA 13.0 is used to preparation of forest plot for Meta-analysis. For assessment of heterogeneity and publication biases I2 statistics along with Begg and Mazumdar's test and Egger's tests are used. Odds ratio (OR) along with forest plots have been showing with 95% confidence interval (CI). RESULTS: All together 10 studies including 1537 pairs of mothers and new births are assessed in present meta-analysis. Present analysis revealed the prevalence of HIV due to MTCT in India as 8.76% (95% CI; 5.76, 12.31). Analysis of subgroups exhibit a higher pooled prevalence in eastern region of India, 10.83% (95% CI: 5.9, 17.81) and lower in in Western region in India, 6.37% (95% CI: 4.65, 8.49). Status of MTCT before and after initiation of universal ART are 10.23% (95% CI 6.61, 14.55) and 7.93% (95% CI 4.18, 12.76) respectively. Associated factors with MTCT of HIV include absence of maternal prevention of MTCT intervention, OR = 10.82 (95% CI: 5.28, 22.17), lacking in administration of infant ARV (antiretroviral), OR = 8.21 (95% CI: 4.82, 14.0) and absence of medical facility during childbirth OR = 3.73 (95% CI: 1.67, 8.33). CONCLUSIONS: In India, pooled HIV prevalence of MTCT as high as 8.78% (95% CI; 5.76, 12.31) among babies born to infected mothers warrants urgent need of focused intervention for providing ART (PMTCT intervention), ensuring proper infant ARV prophylaxis, and avoiding delivery without proper medical facility to pregnant women with HIV for reduction of occurrence in HIV transmission from mothers to children.

HIV Care Among Elderly Population: Systematic Review and Meta-Analysis.

Elderly people living with HIV are increasing. At present in the United States, nearly half of newly diagnosed HIV-infected people are aged >50 years. Diagnosis and treatment of HIV-infected elderly patients tends to be delayed by several health care factors as several life-threatening diseases are common in elderly people. This study aimed to find the pooled HIV prevalence in elderly population and the present situation of continuum care for the elderly HIV patients through systematic review and meta-analysis. All previously published articles from 2000 to 2018 are retrieved using MEDLINE, PUBMED, Cochrane Library, EMBASE, and Google Scholar. DerSimonian and Laird Random Effects model are used to critically appraise articles. STATA 13.0 is used to perform the meta-analysis and quantum-geographic information system (Q-GIS) is used to prepare desired map. I2 statistics has been used to test heterogeneity and publication biases. Results have been presented using forest plots. A total of 28 studies are included in this meta-analysis. Present analysis revealed pooled prevalence of HIV in elderly population as 15.79% with a lower rate of viral suppression as 11.524% (95% confidence interval, CI: 11.199-11.855), where a moderate number 38.643% (95% CI: 38.289-38.997) of elderly patients received antiretroviral therapy (ART) globally. The ART retention rate was 12.769% (95% CI: 12.540-13.001) with 6.15% (95% CI: 6.089-6.212) mortality. Despite successful administration of ART in developing part of the world that have relatively higher retention rates among HIV-infected elderly patients only a small percentage are virally suppressed, largely due to elderly drugs interact with ART and several comorbidities reduce the life span of the elderly people.

Detection of hepatitis B virus infection: A systematic review.

AIM: To review published methods for detection of hepatitis B virus (HBV) infection. METHODS: A thorough search on Medline database was conducted to find original articles describing different methods or techniques of detection of HBV, which are published in English in last 10 years. Articles outlining methods of detection of mutants or drug resistance were excluded. Full texts and abstracts (if full text not available) were reviewed thoroughly. Manual search of references of retrieved articles were also done. We extracted data on different samples and techniques of detection of HBV, their sensitivity (Sn), specificity (Sp) and applicability. RESULTS: A total of 72 studies were reviewed. HBV was detected from dried blood/plasma spots, hepatocytes, ovarian tissue, cerumen, saliva, parotid tissue, renal tissue, oocytes and embryos, cholangiocarcinoma tissue, etc. Sensitivity of dried blood spot for detecting HBV was > 90% in all the studies. In case of seronegative patients, HBV DNA or serological markers have been detected from hepatocytes or renal tissue in many instances. Enzyme linked immunosorbent assay and Chemiluminescent immunoassay (CLIA) are most commonly used serological tests for detection. CLIA systems are also used for quantitation. Molecular techniques are used qualitatively as well as for quantitative detection. Among the molecular techniques version 2.0 of the CobasAmpliprep/CobasTaqMan assay and Abbott's real time polymerase chain reaction kit were found to be most sensitive with a lower detection limit of only 6.25 IU/mL and 1.48 IU/mL respectively. CONCLUSION: Serological and molecular assays are predominant and reliable methods for HBV detection. Automated systems are highly sensitive and quantify HBV DNA and serological markers for monitoring.

Burden and Correlates of HIV among Men Who Have Sex with Men in West Bengal, India: Analysis of Sentinel Surveillance Data.

BACKGROUND: Little is known about the socio-behavioral risk factors for HIV acquisition among hard-to-reach men who have sex with men (MSM) population in India, particularly from the densely populated eastern part. Thus to measure the burden and correlates of HIV among MSM in West Bengal state of eastern India, a cross-sectional analysis of the national HIV Sentinel Surveillance (HSS) data was conducted. METHODS: In 2011, between July and September, involving all sentinel sites of the state, 1237 consenting MSM were anonymously interviewed and tested for HIV following national guidelines. Using a short, structured questionnaire, information was collected on socio-behavioral factors along with sexual practices and was analyzed to determine burden of HIV and the role of its socio-behavioral correlates on HIV acquisition. RESULTS: Among participants, mean age was 23.4 years, 44.55% were "Kothis" (usually receptive partner) and 25.1% admitted receiving money for sex with man. HIV sero-positivity was 5.09%. Using logistic regression method, for both bivariate and multivariate (with saturated model) analyses, transport-workers [adjusted odds ratio (AOR)=8.95, 95% confidence interval (95%CI): 1.09-73.71), large business-owners/self-employed (AOR=8.46, 95%CI: 1.25-57.49), small business-owners/cultivators (AOR=7.90, 95%CI: 1.67-37.38), those who visited the sentinel site for official purposes (AOR=7.60, 95%CI: 1.21-47.83) and paying money for having sex with men (AOR=3.03, 95%CI: 1.10-8.33) were strongly associated with higher HIV sero-positivity with than their counterparts. Using the parsimonious model for multivariate analysis, Kothis (AOR=4.64, 95%CI: 1.03-20.89), paying (AOR=2.96, 95%CI: 1.15-7.58) or receiving (AOR=2.06, 95%CI: 1.06-3.99) money for having sex with a man were associated with higher risk of HIV. CONCLUSIONS: Focused intervention targeting the high risk MSM subgroups including Kothis, transport-workers, business-owners/self-employed and those who exchanged money for having sex with men, seemed to be the need of the hour for preventing the spread of HIV infection within and from this understudied population.

Comparative assessment of commercial ELISA kits for detection of HIV in India.

BACKGROUND: India harbors the 3rd highest HIV infected population globally. The magnitude of the HIV detection challenge is enormous. ELISA is the most commonly used screening technique for HIV. There is always an acute need for good quality ELISA kits. However, the quality evaluation data on Indian kits are very limited in comparison with internationally recognized kits. This study aimed to evaluate the performance and diagnostic usefulness of five commercially available ELISA kits which are frequently used in India. FINDINGS: The ELISA kits evaluated using an in-house well characterized 100 member sera panel revealed 100% sensitivity for all the batches. However, batch to batch variation in terms of specificity, positive predictive value (PPV) and efficiency, although not statistically significant (p > 0.05), was observed. For specificity, the 3rd generation kits (mean 99.6% to 99.3%) were comparatively better than the 4th generation assays (97.2% to 96.9%). But the 4th generation kits performed far better in the ability for early detection post HIV infection in the 25 member commercial seroconversion panel with a margin of at least 22 days and as high as 35 days than the 3rd generation assays. CONCLUSIONS: The commercial ELISA kits with 100% sensitivity seem appropriate for HIV screening. The ability of early detection post HIV infection favors use of 4th generation kits for ensuring HIV free blood for transfusion. Lot to lot variations, especially kits having the specificity level ≤98.0%, indicate the need for a regular mechanism of kit evaluation for each batch for procuring kits appropriate for intended use.

Performance and diagnostic usefulness of commercially available enzyme linked immunosorbent assay and rapid kits for detection of HIV, HBV and HCV in India.

BACKGROUND: HIV, HBV and HCV pose a major public health problem throughout the world. Detection of infection markers for these agents is a major challenge for testing laboratories in a resource poor setting. As blood transfusion is an important activity saving millions of live every year, it also carries a risk of transfusion transmissible infections caused by these fatal blood borne pathogens if the quality of testing is compromised. Conventional ELISA is regarded as the mostly used screening technique but due to limitations like high cost, unavailability in many blood banks and testing sites, involvement of costly instruments, time taking nature and requirement of highly skilled personnel for interpretation, rapid tests are gaining more importance and warrants comparison of performance. RESULTS: A comparative study between these two techniques has been performed using commercially available diagnostic kits to assess their efficacy for detection of HIV, HBV and HCV infections. Rapid kits were more efficient in specificity with synthetic antigens along with high PPV than ELISA in most cases. Comparison between different ELISA kits revealed that Microlisa HIV and Hepalisa (J. Mitra & Co. Pvt. Ltd.); ERBA LISA HIV1 + 2, ERBA LISA Hepatitis B and ERBA LISA HCV (Transasia Bio-medicals Ltd.) gives uniform result with good performance in terms of sensitivity, specificity, PPV, NPV and efficiency, whereas, Microlisa HCV (J. Mitra & Co. Pvt. Ltd.), Microscreen HBsAg ELISA and INNOVA HCV (Span Diagnostics Ltd.) did not perform well. Rapid kits were also having high degree of sensitivity and specificity (100%) except in HIV Comb and HCV Comb (J. Mitra & Co. Pvt. Ltd.). The kit efficiency didn't vary significantly among different companies and lots in all the cases except for HCV ELISA showing statistically significant variation (p < 0.01) among three kit types. CONCLUSIONS: ELISA is a good screening assay for markers of HIV, HBV and HCV infections. Rapid tests are useful for further detection of false positive samples. ELISA seems the appropriate assay in blood bank. For availability of quality commercial diagnostic assays, evaluation of kit may be helpful.

Human immunodeficiency virus seroprevalence among patients attending a sexually transmitted disease clinic in West Bengal, India.

Sexually transmitted infections (STIs) such as human immunodeficiency virus (HIV) infection have become a major public health problem globally as well as in India. Prevalence of STIs varies across different high risk groups including the population with sexually transmitted diseases (STDs). Individuals with STDs are at a higher risk of acquisition of HIV through the sexual route than the other routes. The tendency of HIV infection was studied in attendees aged 15-49 years in an STD clinic in West Bengal from 2004 to 2008. Blood samples were collected consecutively from 250 attendees per year (a total of 1,250 samples over 5 years) from an STD clinic during 12 weeks (October-December) every year. HIV sero-status was screened using ELISA, and positive samples were subjected to rapid assay and confirmed by Western blot. Overall HIV seropositivity in STD patients was 1.28% (women, 1.04%; men, 1.48%). Data from 5 consecutive years showed a prominent decline from 2.40% (2004) to 0.0% (2007) and a minor increase (1.6%) in 2008, which was not statistically significant (χ(2) = 4.6, df = 4, P > 0.05). The highest seroprevalence (1.66%) was observed in the 25-29 age group, and the lowest (0.87%) was observed in the 40-44 age group. The overall decreasing tendency of HIV infections signifies the efficiency of current interventions. Focused intervention for the 25-29 age group may help in decreasing HIV infections further.