Implications of COVID-19 on Thrombotic Profile of Severely Affected Patients.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is a novel viral disease that spread as a global pandemic in 2020 by infecting millions of people across the world. Its clinical prognosis is dependent on various coagulatory parameters since thrombotic events are frequently associated with infection severity. METHODS: A total of 383 COVID-19 patients enrolled in Rajiv Gandhi Super Specialty Hospital, Delhi, India, were included in the present retrospective study. Patients were divided into three categories, severe (n = 141), moderate (n = 138), and mild (n = 104) based on infection severity. Various thrombotic parameters and anticoagulant levels were measured in 70 patients and further analyzed. RESULTS: Coagulopathy is seen in COVID-19 patients (n = 70) with a significant increase in fibrinogen, D-dimer levels, and prothrombin time in patients with severe and moderate disease compared to patients with a mild infection. Approximately, 70% of patients with severe and moderate disease demonstrated fibrinogen levels higher than the standard reference range. 60.41% of patients with severe disease showed significantly higher D-dimer levels. Thrombotic parameters were notably elevated in the nonsurvivors group compared to COVID-19 survivors. Nearly, 91% of patients with severe infection had anticoagulant protein S levels below the reference range. CONCLUSION: COVID-19 infection severely impacts the blood coagulation cascade, which might lead to the manifestation of severe symptoms and increased mortality in patients.

Potential association of COVID-19 and ABO blood group: An Indian study.

Coronavirus disease 2019 (COVID-19) transmits from person to person mainly through respiratory droplets and coughing. Infection severity ranges from asymptomatic and mild infection to those with moderate and severe symptoms which may lead to multiple organ failure and mortality. Infection severity largely depends on individual's immune response, age and co-morbidities. Present study categorized COVID-19 infected patients based on their infection severity and linked COVID-19 severity with age, gender and ABO blood group types. Clinical details of 383 COVID-19 patients were collected from Rajiv Gandhi Super Specialty hospital (RGSSH), India; divided into three groups; mild, moderate and severe patients, based on their symptoms. Present analysis revealed that age plays major role in infection severity, as the symptoms are more severe in patients above 45 years. Infection rate was higher in males compared to females. Most patients with A(+ve) and B(+ve) blood group were severely affected compared to those of blood group type O(+ve) and AB(+ve). O(+ve) blood group was least represented in severe patients. Present findings could be helpful in generating awareness amongst the population regarding susceptibility towards the COVID-19 infection. This supportive information would help clinicians and health workers to propose new strategies and tactical solution against COVID-19 infection.

Chlamydia trachomatis infection in HIV-infected women: need for screening by a sensitive and specific test.

Reproductive tract infection (RTIs)/sexually transmitted infections (STIs) are recognized as a major public health problem, particularly due to their relationship with HIV infection. Early detection and treatment of Chlamydia trachomatis infection (CTI) among HIV-infected and HIV-uninfected women may impact heterosexual HIV transmission. A total of 120 participants were enrolled: 30 HIV seropositive women with symptoms of RTIs, 30 HIV seropositive women without symptoms of RTIs, 30 HIV seronegative women with symptoms of RTIs, and 30 HIV seronegative women without symptoms of RTIs. One endocervical swab was collected from all participants and CTI was detected by real-time PCR (COBAS TaqMan CT Test, v2.0). CTI was detected in 4 (6.67%) HIV-infected women and in 1 (1.67%) HIV-uninfected woman (OR 4.214; 95% CI 0.457-38.865). Vaginal discharge was present in almost half of HIV-infected and HIV-uninfected women; lower abdominal pain was present in 11 (18.3%) of HIV-infected and in 9 (15%) of HIV-uninfected women. This study showed that CTI is more prevalent among HIV-infected females as compared to HIV-uninfected females. As the use of real-time PCR is not feasible in most hospitals, efforts should be made to develop a simple, sensitive, and specific test to identify women with CTI for prevention of sequelae and HIV transmission.

Flow cytometry profiling of cellular immune response in COVID-19 infected, recovered and vaccinated individuals.

INTRODUCTION: SARS-CoV-2 has infected over 753 million individuals and caused more than 6.8 million deaths globally to date. COVID-19 disease severity has been associated with SARS-CoV-2 induced hyper inflammation and the immune correlation with its pathogenesis remains unclear. Acute viral infection is characterised by vigorous coordinated innate and adaptive activation, including an early cellular response that correlates well with the amplitude of virus specific humoral response. OBJECTIVE: The present study covers a wide spectrum of cellular immune response against COVID-19, irrespective of infection and vaccination. METHODS: We analysed immune status of (a) COVID-19 hospitalised patients including deceased and recovered patients, and compared with home isolated and non-infected healthy individuals, and (b) infected home isolated individuals with vaccinated individuals, using flow cytometry. We performed flow cytometry analysis of PBMCs to determine non-specific cell-mediated immune response. RESULTS: The immune response revealed extensive induction and activation of multiple immune lineages, including T and B cells, Th17 regulatory subsets and M1, M2 macrophages in deceased and hospitalised recovered patients, vaccinated and healthy individuals. Compromised immune cell expression was observed in deceased patients even in later stages, while expression was restored in hospitalised recovered patients and home isolated individuals. CONCLUSION: The findings associated with recovery and convalescence define a new signature of cellular immune response that persists in individuals with SARS-CoV-2 infection and vaccination. The findings will help in providing a better understanding of COVID-19 disease and will aid in developing better therapeutic strategies for treatment.

Evaluation of altered miRNA expression pattern to predict COVID-19 severity.

Outbreak of COVID-19 pandemic in December 2019 affected millions of people globally. After substantial research, several biomarkers for COVID-19 have been validated however no specific and reliable biomarker for the prognosis of patients with COVID-19 infection exists. Present study was designed to identify specific biomarkers to predict COVID-19 severity and tool for formulating treatment. A small cohort of subjects (n = 43) were enrolled and categorized in four study groups; Dead (n = 16), Severe (n = 10) and Moderate (n = 7) patients and healthy controls (n = 10). Small RNA sequencing was done on Illumina platform after isolation of microRNA from peripheral blood. Differential expression (DE) of miRNA (patients groups compared to control) revealed 118 down-regulated and 103 up-regulated known miRNAs with fold change (FC) expression ≥2 folds and p ≤ 0.05. DE miRNAs were then subjected to functional enrichment and network analysis. Bioinformatic analysis resulted in 31 miRNAs (24 Down-regulated; 7 up-regulated) significantly associated with COVID-19 having AUC>0.8 obtained from ROC curve. Seventeen out of 31 DE miRNAs have been linked to COVID-19 in previous studies. Three miRNAs, hsa-miR-147b-5p and hsa-miR-107 (down-regulated) and hsa-miR-1299 (up-regulated) showed significant unique DE in Dead patients. Another set of 4 miRNAs, hsa-miR-224-5p (down-regulated) and hsa-miR-4659b-3p, hsa-miR-495-3p and hsa-miR-335-3p were differentially up-regulated uniquely in Severe patients. Members of three miRNA families, hsa-miR-20, hsa-miR-32 and hsa-miR-548 were significantly down-regulated in all patients group in comparison to healthy controls. Thus a distinct miRNA expression profile was observed in Dead, Severe and Moderate COVID-19 patients. Present study suggests a panel of miRNAs which identified in COVID-19 patients and could be utilized as potential diagnostic biomarkers for predicting COVID-19 severity.

Evaluation of SARS-CoV-2 antibody responses in healthcare workers at a tertiary care COVID 19 dedicated hospital in Delhi.

PURPOSE: Amidst the on-going SARS-CoV-2 pandemic, healthcare workers have been at a greater risk of disease exposure as they are working in environments chiefly involved in the COVID-19 patient care since March 2020. SARS-CoV-2 antibody testing can prove to be a valuable tool for better understanding of prevalence of disease exposure in this population. Therefore, we conducted this study to grasp the sero-prevalence of COVID-19 antibodies in our hospital to better comprehend the duration of IgG response. METHODS: This was a longitudinal study involving 305 healthcare workers at Rajiv Gandhi Super Speciality Hospital spanning over a period of four months starting from October 2020 to January 2021. Serum samples were obtained from the study group taken as Day 0 of the study and were screened for the presence of SARS-CoV-2 IgG antibodies using semi-quantitive enzyme linked immunoassay technology from ERBAlisa (India). The Antibody Index was determined. Those showing reactive in the screening test were further followed up on a monthly basis till January 2021 for serial antibody testing. RESULTS: The overall seroprevalence for IgG response among the workers was found to be 21.96%. Seropositivity rate was observed to be significantly higher in those having a history of RT-PCR confirmed COVID-19 infection (45.09%) CONCLUSIONS: Our study demonstrated that healthcare workers have a higher sero-prevalence. Our study also demonstrated that the antibodies developed following COVID-19 infection had a waning effect of protective response following infection.

Epidemiological trend and clinical profile of COVID-19 patients: Experience from a designated COVID-19 center in Delhi.

Objective: To study the epidemiological characteristics of the pandemic by describing the clinical profile of the COVID-19 patients presenting to a super specialty hospital. Methods: This was a descriptive study using medical records of patients who tested positive for SARS-CoV-2 RNA using reverse transcription-polymerase chain reaction between 17th March and 15th January 2021 while maintaining confidentiality. The clinical and demographic data of all the patients were entered in a Microsoft Excel and statistical analysis was done using SPSS 21 software. Regression analysis was performed and a P value < 0.05 was considered to be statistically significant. Results: A total of 3534 patients were enrolled in this study aged 9-96 years. Among patients with symptoms, fever and cough were the most common presenting symptoms, while 5.6% of the patients were asymptomatic. Hypertension was the most common comorbidity (37%), while no comorbidities were present in 43.0% of the participants and this was statistically significant for age (P = 0.000). Among patient outcomes, >50% of patients were in home isolation, while 11% of patients had a fatal outcome. Elder age group had a higher proportion of expiry among outcomes (P <= 0.001). Most patients had a hospital stay of 9-11 days. A total of 63 health workers were included with male: female ratio being 3.5:1. Conclusion: Our study reflects that majority of the positive cases that presented to the hospital had mild/moderate symptoms. We believe that appropriate triaging of patients followed by early institution of medicine and good critical care services may help to control this epidemic.

Gene variants in pro-coagulant and anti-coagulant genes could be prognostic genetic markers of COVID-19 susceptibility.

Background: Present study aimed to identify DNA polymorphisms (variants) which can modulate the risk of COVID-19 infection progression to severe condition. TaqMan based SNP genotyping assay was performed for 11 single nucleotide polymorphisms (SNPs) in pro-coagulant and anti-coagulant genes. Methodology: A total of 33 COVID-19 patients, including dead, severe and moderately infected individuals were compared to 35 healthy controls. Both alleles in the SNP were labelled with two different fluorescent dyes (FAM and VIC) during assay formulation. DNA of study subjects were mixed with SNP assay and TaqMan master mix on 96 well PCR plate according to manufacturer's protocol and RT-PCR was performed. Allelic discrimination assay gave clear results for presence of specific allele in each sample. Three SNPs were located in the pro-coagulant genes, another three involved in blood clot dissolution while rest five were in the genes encoding natural anti-coagulants. COVID-19 infected patients were further sub-divided into three groups, deceased (n = 16), severe (n = 10) and moderately infected (n = 7). Results: SNP genotyping showed significant differences between COVID-19 patients and controls in two SNPs, rs6133 in Selectin-P (SELP) and rs5361 in Selectin-E (SELE) gene. Also, rs2020921 and rs8176592, in clot dissolution genes, tissue Plasminogen activator (tPA) and tissue factor pathway inhibitor (TFPI) respectively showed significant genotypic and allelic difference in patients of COVID-19 compared to healthy controls. Further three SNPs rs2227589, rs757583846, and rs121918476 in natural anti-coagulant genes anti-thrombin III (ATIII), protein C (PROC), and protein S (PROS) respectively showed statistically significant difference between the study groups. Conclusion: Our findings indicate that gene variants, those involved in coagulation and anti-coagulation may play a major role in determining individual susceptibility to COVID-19.

Seroprevalence of syphilis by VDRL test and biological false positive reactions in different patient populations: Is it alarming? Our experience from a tertiary care center in India.

INTRODUCTION: Many centers for sexually transmitted infections in India perform only a single screening assay for diagnosis of syphilis which may yield biological false positive (BFP) reactions. AIMS AND OBJECTIVE: The aim of this study was to determine the true picture of seroprevalence of syphilis and BFP reactions in different patient groups. MATERIALS AND METHODS: A total of 57,308 serial serum samples obtained over a period of 5 years from different patient groups were screened by venereal disease research laboratory (VDRL) test both qualitatively and quantitatively. VDRL reactive sera were confirmed by Treponema pallidum hemagglutination (TPHA) test. RESULTS: The overall seroprevalence of syphilis by VDRL test was 1.27%, and BFP rate in test population was 0.14%. The rate of BFP reactions among total tested male (0.44%) and female (0.1%) patients differs significantly. Out of 733 VDRL reactive samples, 81 were BFP, i.e., BFP reaction is occurring at a frequency of 11% of the total VDRL reactive samples (ratio of 8:1 for true positives/BFP). Similarly, among antenatal cases, almost 24% of the total VDRL reactive samples were BFP, or for every 116 true positives, there were 37 (almost one-third) BFP. CONCLUSION: Although the overall seroprevalence of syphilis is low; the frequency of occurrence of BFP reactions is quite alarming. Hence, treponemal test must be used for confirmation of VDRL reactive sera.

Neurological Associations of COVID-19-Do We Know Enough: A Tertiary Care Hospital Based Study.

The neurotrophic potential of SARS-CoV-2 virus is manifesting as various neurological disorders in the present pandemic. Nervous system involvement can be due to the direct action of the virus on the brain tissue or due to an indirect action through the activation of immune-mediated mechanisms. This study will discuss the detailed systematically evaluated clinical profile and relevant investigations and outcome of 14 laboratory confirmed SARS-CoV-2 positive patients presenting with neurological signs and symptoms. The patients were further categorized into confirmed, probable, and possible neurological associations. The probable association was found in meningoencephalitis (n = 4), stroke (n = 2), Guillain-Barré syndrome (n = 1), and anosmia (n = 1). The other six patients had coexisting neurological diseases with SARS-CoV-2. One patient with a large artery stroke succumbed to the illness due to respiratory complication. Memory impairment as a sequela is present during follow up of one encephalitis patient. Presently the early recognition and diagnosis of neurological manifestations remains a challenge for clinicians as the SARS-CoV-2 related neurological manifestations are in evolution. A long-term correlation study of clinical profile, radiological and laboratory investigations, along with neuropathological studies is needed to further understand the pathophysiology behind the SARS-CoV-2 neurological manifestations. Further understanding will facilitate timely recognition, therapeutic intervention, and possible prevention of long-term sequalae.

Trends and clinico-epidemiological profile of COVID-19 patients at a designated COVID-19 hospital in Delhi, North India.

BACKGROUND: The coronavirus disease (COVID-19) presents across a spectrum of signs and symptoms and shows clinico-epidemiological predilections (elderly, those with comorbidities). Delhi is among the highest burden states in India. OBJECTIVES: To report the case detection trends and clinico-epidemiological profile of patients tested positive at a designated COVID-19 hospital in Delhi in Northern India. METHODS: Using an observational (descriptive design) we analyzed data from the electronic medical records of the hospital. All individuals testing positive for SARS-CoV-2 RNA using reverse transcription polymerase chain reaction (RT-PCR) between 17th March and 07th May 2020 (both dates inclusive) were included. Case detection trend (7-day moving averages) was plotted. Clinico-epidemiological profile of patients was summarized statistically. RESULTS: Total 308 positive cases were enrolled in this study. The median age of participants was 48 years (09-95 years) men (47.9 ± 16.4 years) and women (43.5 ± 14.0 years). Men to women ratio was 3.4:1 with a statistically significant difference (P < 0.001). During the study timeframe, 166 (54.0%) patients had an outcome: 11 (6.6%; 95% CI: 3.4-11.6) expired and 155 recovered (recovery rate: 93.4%; 95% CI: 88.5-96.7). Chance of death was significantly associated with the higher age group (P = 0.005). The commonest clinical symptoms noted were fever (38.9%) and cough (38.6%). Majority (56.6%) had mild to moderate symptoms, 12.6% had severe symptoms and the remaining were asymptomatic (30.8%). 31 patients (26.05%) needed ICU care. Total 119 patients (38.6%) had various preexisting comorbidities, most commonly diabetes mellitus (35.0%) and hypertension (34.0%). However, the comorbidities were not associated with age (P = 1.000). CONCLUSION: Triangulation of data and careful analysis of trends in designated COVID-19 hospitals and other institutional settings may help inform surge preparedness and care provisioning. Stringent containment strategies must continue as the pandemic is intensifying.

Correlation between Venereal Diseases Research Laboratory titers and CD4 T-lymphocyte count determined by flow cytometry in HIV-infected adults: A 5-year study.

INTRODUCTION: Venereal Diseases Research Laboratory (VDRL) is one of the key tests for the diagnosis of syphilis; however in HIV-positive individuals, it has been reported to give inappropriate results at times. Thus, this study was conducted to determine if the VDRL test titers vary with the severity of immunosuppression as determined by CD4 cell count. MATERIALS AND METHODS: A total of 2630 samples from HIV-positive adults were tested by qualitative and quantitative VDRL test and if reactive, by Treponema pallidum hemagglutination (TPHA) test. CD4 cell counts were determined at the same time by flow cytometry (BD FACSCount™ system). Correlation between CD4 T-lymphocyte cell count and VDRL titers was sought for. RESULTS: Nearly 6.7% (176/2631) of individuals were VDRL reactive, males more than females (7.6% vs. 5.1%, P = 0.014). Four of the VDRL-reactive patients were found negative by TPHA test and were excluded from further study. VDRL titers ranged from weakly reactive to being reactive at 1:128 (median = 1:2). The CD4 cell count ranged from 23 cells/µl to 883 cells/µl (median = 276 cells/µl, mean = 323.9 ± 200.9). Pearson's coefficient of correlation (R) between CD4 cell count and VDRL titers was calculated to be 0.0559; coefficient of determination (R2) was 0.0031. CONCLUSIONS: Although the correlation coefficient shows a positive correlation, the association was very weak. Therefore, CD4 cell count cannot be expected to influence VDRL titers in HIV-positive adults significantly.

Evaluation of Baseline CD4+ T Cell Counts and ART Requirement in Newly Diagnosed HIV Seropositive Individuals in a Tertiary Care Hospital of Northern India.

INTRODUCTION: Antiretroviral Therapy (ART) has changed the outlook of Human Immune-deficiency Virus (HIV)/Acquired Immuno Deficiency Syndrome (AIDS) patients worldwide. AIM: To analyse the trends in baseline CD4+ T cell counts and ART requirements in newly diagnosed HIV seropositive individuals in a Tertiary care hospital of Northern India. MATERIALS AND METHODS: Out of 1263 HIV seropositive clients identified from January 2012 to June 2014, the baseline CD4+ T cell counts of only those 470 clients were analysed, who registered at the linked ART centre. RESULTS: The mean baseline CD4+ count of the study group was 249.77±216.0cells/mm3 and that of male and female were 300.31±240.47cells/mm3 and 232.38±204.25cells/mm3 respectively. A total of 259 of 334 (77.54%) HIV reactive males, 83 of 130 (63.85%) HIV reactive females and overall 348 of 470 (74.04%) required antiretroviral treatment on enrolment. CONCLUSION: In the present study, about three-fourth of newly diagnosed HIV positive Indian patients required initiation of ART at registration. The relatively low baseline CD4+ T cell counts in this population highlights the need for timely baseline CD4+ counts testing of HIV positive patients and the urgency of initiating treatment in HIV reactive individuals in Indian health care settings.

Co-Infections and Sero-Prevalence of HIV, Syphilis, Hepatitis B and C Infections in Sexually Transmitted Infections Clinic Attendees of Tertiary Care Hospital in North India.

BACKGROUND: HIV, syphilis, hepatitis B and C (HBV & HCV) infections modify the epidemiology and presentation of each other. This study aimed to estimate the seroprevalence of these infections and their co-infections in sexually transmitted infections (STI) clinic attendees in New Delhi, India. METHODS: A retrospective study including 220 patients was conducted during May 2014 through December 2014. Serodiagnosis of HIV was performed as per Strategy III of NACO guidelines; syphilis by VDRL followed by TPHA; HBV and HCV by rapid immuno-chromatographic test followed by ELISA. RESULTS: Male subjects were slightly more in number as compared to females (56.36% vs. 43.63%). Twelve (5.45%), 14 (6.36%), three (1.36 %) and one (0.45%) were reactive for HIV, VDRL, HBV and HCV, respectively. Three were both HIV and syphilis positive and one was both HIV and HBV positive; no co-infections of HBV/HCV, HIV/HBV/HCV and HIV/HBV/HCV/syphilis coexisted. CONCLUSIONS: High prevalence of HIV, HBV, HCV and syphilis in STI clinic attendees mandate routine screening to detect co-infections and follow prompt therapy in order to minimize their sequelae.

Utility of Laboratory Diagnosis for Confirmation of the Syndromic Case Management in Married Indian Women with Vaginal Discharge.

OBJECTIVE: WHO and NACO recommend treatment of STIs/RTIs on the basis syndromic case management (SCM), even without laboratory confirmation, which may lead to over-treatment. Thus, this study was conducted to evaluate the utility of laboratory diagnosis for confirmation of patients with vaginal discharge diagnosed on the basis of SCM. METHODOLOGY: 234 married women in reproductive age group, diagnosed as having vaginal discharge syndrome were included. Normal saline wet-mount slide preparations were made for detection of motile trichomonads. Gram stained smear were prepared and scored as per classification developed by Nugent. The presence of pseudohyphae and/or budding yeast cells was considered diagnostic of candidal infection. VDRL, TPHA and HIV testing were also done as per protocol. RESULTS: The median age of the study population was 34 years. Most common cause was bacterial vaginosis (positive= 21.4%, 95% CI= 16.6-27.1%; intermediate score= 17.5%, 95% CI= 13.2-22.9%), followed by candidiasis (13.7%, 95% CI= 98-18.7%) and trichomoniasis (0.4%, 95% CI= 0-2.6%). No etiological diagnosis for vaginal discharge could be established in approximately half of the women. Only two women were HIV positive; one was reactive by VDRL and TPHA tests. CONCLUSION: Our study highlights the possible lacunae in SCM. Large number of patients may be over-treated if only syndromic management is followed, with financial, medical and social implications. Thus we recommend, the treatment maybe initiated on the basis of SCM, but it is essential that laboratory diagnosis is sought for and the treatment modified accordingly.

Sexually transmitted infections and HIV in self reporting men who have sex with men: A two-year study from India.

Homosexuality is not legally and socially accepted in India. Thus, this area of research has largely been ignored by Indian authors, resulting in dearth of knowledge, particularly with respect to sexually transmitted infections (STIs) in this high-risk group. Over a period of two years (2013-2014), 738 males sought care at skin and venereal diseases clinics, 52 (7.05%, 95% CI=5.4-9.14%) of who identified themselves as MSM and were enrolled in the study. Diagnosis was made on the basis of clinical presentation and laboratory testing, wherever indicated. Thirty six percent of MSM had only homosexual preferences, while 64% were bisexual. The most common sexually transmitted infection was genital warts (23.08%, 95% CI=13.58-36.28%). Fourteen patients (26.92%, 95% CI=16.67-40.35%) were VDRL and TPHA positive (two, five and four with primary syphilis, secondary syphilis and latent syphilis, respectively). These were followed by genital herpes (11.54%, 95% CI=5.03-23.34%), genital molluscum contagiosum (9.62% 95% CI=3.75-21.04%), and gonorrhea (5.77%, 95% CI=1.38-16.25%). Of those tested, 23.08% (95% CI=13.58-36.28%) of patients were reactive for HIV serology. Thus, MSM is a high-risk group with high prevalence of HIV and other STIs in this group, mandating greater focus, education and counseling.

Evaluation of SD BIOLINE Syphilis 3.0 for Rapid Diagnosis of Syphilis: Report from a Regional Sexually Transmitted Infection Reference Laboratory in North India.

BACKGROUND: Serology is considered the mainstay of syphilis diagnosis. The limitations of the traditional serological methods and the advent and availability of novel immunochromatographic assays have led to the widespread application of rapid point-of-care procedures as screening tools for syphilis. However, these tests have not been extensively evaluated. This study was designed to evaluate the performance of a rapid syphilis diagnostic test known as SD BIOLINE Syphilis 3.0 (SD Biostandard Diagnostics Private Limited, Gurgaon, Haryana, India). MATERIALS AND METHODS: A panel comprising of 50 venereal disease research laboratory reactive and 50 nonreactive sera was tested using SD BIOLINE Syphilis 3.0. The performance of the test was evaluated using IMMUTREP Treponema pallidum hemagglutination assay (TPHA) (OMEGA Diagnostics Limited, Scotland, United Kingdom) as the reference standard and sensitivity, specificity, and negative and positive predictive values were calculated. RESULTS: The sensitivity, specificity, and positive and negative predictive values of SD BIOLINE Syphilis 3.0 were 92.86% (confidence interval of 95%: 80.52-98.50%), 98.28% (90.76-99.96%), 97.50% (86.84-99.94%), and 95.00% (86.08-98.96%), respectively, compared to TPHA as the gold standard. CONCLUSION: Keeping in view the high sensitivity and specificity of SD BIOLINE Syphilis 3.0, we conclude that the test can be used as a tool for rapid on-site diagnosis of syphilis and as an alternative to TPHA for detection of antibodies to Treponema pallidum.

HIV/AIDS awareness among VCT clients: a cross-sectional study from Delhi, India.

The contribution of India to the global burden of HIV/AIDS is significant. A major barrier that the country has faced in its battle against this disease is the inadequate and inaccurate information about it among the population. The present analysis explores the knowledge about HIV/AIDS among clients attending a voluntary counselling and testing (VCT) facility in India. Two hundred clients attending the VCT facility were assessed in this regard using a structured predesigned questionnaire. Sixty-three (31.5%) of the respondents had never heard of HIV/AIDS. In comparison to males, a significantly higher number of females had not heard about the disease (P < 0.01). Lower levels of education of participants were found to be significantly associated with the response of not having heard of HIV/AIDS (P < 0.01) as was an occupation status of being an unemployed man/housewife (P = 0.002). For the 137 (68.5%) respondents who had heard about HIV/AIDS, television was the source of information in 130 (94.9%) followed by posters in 93 (67.9%) and newspapers in 88 (64.2%). While the knowledge about HIV transmission and prevention was good, the extent of misconceptions was high (61.8%). Our study highlights the strong need to raise the levels of HIV awareness among Indian population.

Rapid Tests versus ELISA for Screening of HIV Infection: Our Experience from a Voluntary Counselling and Testing Facility of a Tertiary Care Centre in North India.

Early and accurate diagnosis of human immunodeficiency virus (HIV) infection is essential for timely identification of patients needing antiretroviral therapy and for instituting HIV prevention strategies. The primary methodology for HIV testing has shifted from enzyme linked immunosorbent assay (ELISA) to rapid diagnostic tests (RDTs) in recent years, especially in resource limited settings. However, the diagnostic performance of RDTs is a matter of concern. In the present study the performance of an RDT being used as the initial test in serial testing based algorithm for HIV diagnosis was compared with ELISA. Seven hundred and eighty-seven sera, tested at the voluntary counselling and testing facility employing a serial testing algorithm (based on SD Bioline HIV-1/2 3.0 as the first test), were subsequently tested with Microlisa-HIV for anti-HIV antibodies. The first test missed 9 HIV reactive samples and also registered 5 false positives. The sensitivity, specificity, and negative and positive predictive values of the first test were 77.5%, 99.3%, and 98.8% and 86.1%, respectively, taking ELISA as the standard test. Our study highlights that RDTs fare poorly compared to ELISA as screening assays and that reactive results by RDTs need to be confirmed by western blot for a positive serodiagnosis of HIV infection.

Correlation of CD4 T Cell Count and Plasma Viral Load with Reproductive Tract Infections/Sexually Transmitted Infections in HIV Infected Females.

BACKGROUND: Sexually transmitted infections (STIs) plays a major role in the spread of Human immunodeficiency virus (HIV) due to common route of transmission. These infections display an epidemiological synergy with HIV. AIM: The aim of this study was to analyse the correlation of CD4 T lymphocyte cell count, HIV-1 plasma viral load with Reproductive tract infections/Sexually transmitted infections (RTIs/STIs) in HIV infected females. MATERIALS AND METHODS: The study included 60 HIV infected females. An informed consent was taken from all the study subjects. Relevant specimens (genital specimen and blood) were collected for laboratory diagnosis of various RTIs/STIs, CD4 cell count and plasma viral load estimation. RESULTS: Mean CD4 count of females with bacterial vaginosis, vaginal candidiasis, trichomoniasis, syphilis and herpes simplex infection were lower as compared to other HIV infected cases and mean plasma viral load of bacterial vaginosis, vaginal candidiasis, trichomoniasis and syphilis were higher as compared to other HIV infected cases but this difference was not statistically significant. CONCLUSION: This study highlights the importance of routine screening for STIs/RTIs of all the HIV infected females for RTIs/STIs irrespective of CD4 cell count and plasma viral load.