An Integrated DAIDS Laboratory Oversight Framework: Application of the DAIDS GCLP Guidelines.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, consistency, validity, and the safety of the clinical research or trial participants and laboratory staff, as well as ensures adherence to regulatory requirements. This article describes the application of the DAIDS GCLP Guidelines, the DAIDS Integrated Laboratory Oversight Framework, and the coordinated efforts of the collaborative oversight team of laboratory experts to support and monitor the performance of over 175 participating laboratories worldwide. Data from two self-administered online surveys conducted in 2017 and 2023 assessed the laboratory staff's experience implementing the GCLP Guidelines. The results of the 2017 survey were instrumental in informing changes to GCLP audit activities and promoting harmonization in the approach to laboratory oversight. A key finding from the 2023 survey results is the preference for hybrid GCLP training encompassing face-to-face and online modules. Overall, both surveys acknowledged satisfaction with applying and implementing GCLP Guidelines. The need to effectively disseminate information about DAIDS laboratory oversight requirements to support the improved implementation of GCLP Guidelines was notable from both survey results. The collaborative team of laboratory experts and the integrated oversight approach promote knowledge-sharing and accountability to support the application of the GCLP Guidelines and compliance monitoring. The systematic implementation of the integrated laboratory oversight activities helped identify valuable lessons for improving laboratory performance and opportunities to strengthen quality oversight for laboratories participating in clinical research or trials. .

Immunomodulatory and AntiOxidant Potential of Polyherbal Dhatryadi Rasayana in the Form of Churna and Granules.

Dhatryadi Rasayana revitalizes the human body and helps in maintaining health with the elimination of ill effects of various diseases. The effective delivery systems for Rasayana may affect the profound effect of active principles in the body. The present study deals with investigation and evaluation of phytochemical constituents, physicochemical characteristics, along with antioxidant and immunomodulatory effects of Dhatryadi Rasayana in churna (powder) and granule formulations. Dhatryadi Rasayana churna and its granules were studied for various physicochemical parameters, e.g., moisture content, ash-value, acid-insoluble ash content, water-soluble extractive, alcohol-soluble extractive, bulk density, tapped density, angle of repose, Carr's index, Hausner's ratio, total sugar, reducing sugar, non-reducing sugar, heavy metals, total microbial load, etc. In vitro antioxidant potential of Dhatryadi Rasayana churna and its granules was determined by scavenging the DPPH and FRAP assays. The immunomodulatory activities of Dhatryadi Rasayana churna and its granules were studied in Wistar albino rats and the complete blood count (CBC), delayed-type hypersensitivity reaction (DTH), and hemagglutination antibody titer were assessed. Dhatryadi Rasayana churna contained alkaloids (0.50 ± 0.298% w/w), tannins (9.84 ± 1.527% w/w), saponins (4.18 ± 2.126% w/w), and flavonoids (9.34 ± 1.026% w/w), while its granules contained 11.08 ± 2.468% w/w total tannins, 2.40 ± 1.132% w/w alkaloids, and 12.46 ± 2.645% w/w total flavonoids. The DPPH scavenging effect was determined by IC50 (churna - 23.89 µg/mL; granules - 9.33 µg/mL), and the antioxidant capacity assessed by FRAP was 77.0 mmol/100 g equivalent of ascorbic acid for churna and 50 mmol/100 g equivalent of ascorbic acid for granules. Dhatryadi Rasayana churna and its granules reflected a significant immunostimulatory effect on both the cell-mediated and humoral immune systems in Wistar albino rats. Moreover, churna and granules of Dhatryadi Rasayana revealed significant antioxidant and immunomodulatory activities and these may be applied for treating different diseases as well as improving the immunity of the body.

Anticoccidial effects of Phyllanthus emblica (Indian gooseberry) extracts: Potential for controlling avian coccidiosis.

The protozoan parasite Eimeria causes avian coccidiosis, impacting the poultry industry worldwide. Resistance development to current anticoccidials are a concern and cost effective, environmentally friendly alternatives are needed. Anti-malarial effects of Phyllanthus emblica encouraged us to investigate its anticoccidial effects. Aqueous extracts and dried-powder of P. emblica leaf and fruit were tested for effect(s) on oocyst sporulation in vitro and oocyst infectivity in vivo. Eimeria tenella oocysts were randomly assigned to groups and treated with different concentrations (0.001, 0.1, 1, 5, 25, 50 and 100%) of P. emblica crude extracts in triplicates for three repeats. Sporulated, unsporulated, deformed and lysed oocysts were recorded at 24, 48 and 72 h. Broiler chicks (21 days old) were randomly assigned into four groups with 5 chicks each and experimentally infected on Day 0 with 1 × 104 oocysts/bird: (A) infected and un-supplemented diet, (B) infected and supplemented diet (P. emblica powder 1 g/bird/day), (C) infected with P. emblica-treated oocysts and un-supplemented diet and (D) infected and diet supplemented only from day14. In vivo experiments were terminated on day28. Significant sporulation inhibition and oocyst lysis (p < 0.05) in vitro were observed in a concentration-dependent with P. emblica treatment. In in vivo experiments, group B showed the highest weight gain, lowest fecal oocyst excretion and mildest histopathological lesions. Extracts of P. emblica remarkably inhibited oocyst sporulation, reduced the oocyst infectivity and lowered the fecal oocyst excretion, and reduced the pathogenicity of E. tenella in chickens. Therefore, P. emblica extract demonstrates great potential to be an effective alternative anticoccidial agent.

Remediation of noxious pollutants using nano-titania-based photocatalytic construction materials: a review.

Nano-titania (n-TiO2), due to its unique photocatalytic and hydrophobic properties, can be used to prepare self-cleaning cement-based smart building materials. The n-TiO2 degrades organic and inorganic pollutants through its photocatalytic action and convert them into non-toxic byproducts, i.e., improves the air quality. In this review, aspects such as methodologies of n-TiO2 synthesis, approaches for n-TiO2 loading on cementitious materials, photocatalytic properties, self-cleaning mechanism, and application of n-TiO2 in cement-based materials have been overviewed. Further, the n-TiO2 can be used either as coatings or admixtures in pavement blocks, mortars/concrete at zebra crossings, road dividers and linings, and high rise buildings. Moreover, the implications and economic aspects of n-TiO2 usage in cement-based materials revealed that n-TiO2 increases the material cost by ~ 27%, (101 to 128.1$) in comparison to conventional building materials. Furthermore, the low-cost carbonized materials such as biochars have been suggested to be used as support of n-TiO2 to lower the cost and improve the remediation efficiency of photocatalytic concrete.

Economic losses due to infection by apple scar skin viroid in Himachal Pradesh, India.

Apple scar skin viroid (ASSVd), the type member of the genus Apscaviroid, induces symptoms only on fruits, which include colour dappling, russeting, cracking and distortion. Studies on viroid incidence were conducted during past five years and incidence up to 90.0 percent was recorded in commercial apple cultivars (Royal Delicious, Red Delicious, Red Gold, Golden Delicious). From 2015 to 2018, forty apple orchards were surveyed in different blocks of Shimla district of Himachal Pradesh and fruits in six orchards were found with typical symptoms of apple scar skin viroid infection without symptoms on leaves. The presence of ASSVd in symptomatic fruits and symptomless leaves were confirmed by RT- PCR. It was also revealed that ASSVd infection not only deteriorate the quality of apple fruits but cause large losses in term of yield, as 17.80 quintal less fruit production was recorded in the affected orchards with loss in net return up to Rs. 3,91,102/- per hectare (72.68% loss in net return per hectare).

Simple, Mobile-based Artificial Intelligence Algorithm in the detection of Diabetic Retinopathy (SMART) study.

INTRODUCTION: The aim of this study is to evaluate the performance of the offline smart phone-based Medios artificial intelligence (AI) algorithm in the diagnosis of diabetic retinopathy (DR) using non-mydriatic (NM) retinal images. METHODS: This cross-sectional study prospectively enrolled 922 individuals with diabetes mellitus. NM retinal images (disc and macula centered) from each eye were captured using the Remidio NM fundus-on-phone (FOP) camera. The images were run offline and the diagnosis of the AI was recorded (DR present or absent). The diagnosis of the AI was compared with the image diagnosis of five retina specialists (majority diagnosis considered as ground truth). RESULTS: Analysis included images from 900 individuals (252 had DR). For any DR, the sensitivity and specificity of the AI algorithm was found to be 83.3% (95% CI 80.9% to 85.7%) and 95.5% (95% CI 94.1% to 96.8%). The sensitivity and specificity of the AI algorithm in detecting referable DR (RDR) was 93% (95% CI 91.3% to 94.7%) and 92.5% (95% CI 90.8% to 94.2%). CONCLUSION: The Medios AI has a high sensitivity and specificity in the detection of RDR using NM retinal images.

Isolation and Speciation of Candida in Type II Diabetic Patients using CHROM Agar: A Microbial Study.

INTRODUCTION: Newer Candida species are now becoming increasingly predominant commensal in the oral cavity. AIM: Aim of the study was to identify and compare different Candida species in the oral cavity of Type II diabetic individuals. MATERIALS AND METHODS: The present microbial study was carried out for the duration of three months. Sixty participants were included in the study and divided into two groups of 30 individual each. Group I consisted of patients with Type II diabetes while Group II consisted of healthy individuals without diabetes or any other systemic disease. A total of 3 ml of unstimulated whole saliva was collected from them and centrifuged at 5000 rpm for fives minutes. This pellet was plated onto CHROM agar medium plates and incubated at 37°C for at least 3-4 days. CHROM agar plates were visualized daily at 24 hours, 72 hours and followed up to seven days to check for growth. Candida speciation was done by counting the different coloured creamy colonies. Comparison of Candida spp. between two groups was done by applying the Student's t-test. A p-value<0.05 was considered as statistically significant. RESULTS: All the species of Candida, namely, Candida albicans, Candida glabrata, Candida dubliniensis, Candida krusei, Candida parapsilosis except for Candida tropicalis showed a significantly higher (p<0.001) occurrence in the diabetic group compared to the healthy group. The highest identified species is C. parapsilosis, second being C. albicans in both the groups. CONCLUSION: C. parapsilosis is now considered as one of the significant causes of Candida infection in the oral cavity. This increased virulence will affect the global burden of Candidiasis as few treatment options are available for this new pathogen.

Streamlining HIV testing for HIV preexposure prophylaxis.

HIV-testing algorithms for preexposure prophylaxis (PrEP) should be optimized to minimize the risk of drug resistance, the time off PrEP required to evaluate false-positive screening results, and costs and to expedite the start of therapy for those confirmed to be infected. HIV rapid tests (RTs) for anti-HIV antibodies provide results in less than 1 h and can be conducted by nonlicensed staff at the point of care. In many regions, Western blot (WB) testing is required to confirm reactive RT results. WB testing, however, causes delays in diagnosis and adds expense. The iPrEx study evaluated the safety and efficacy of daily oral emtricitabine-tenofovir disoproxil fumarate among HIV-seronegative men and transgender women who have sex with men: HIV infection was assessed with two RTs plus WB confirmation, followed by HIV-1 plasma viral load testing. During the iPrEx study, there were 51,260 HIV status evaluations among 2,499 volunteers using RTs: 142 (0.28%) had concordant positive results (100% were eventually confirmed) and 19 (0.04%) had discordant results among 14 participants; 11 were eventually determined to be HIV infected. A streamlined approach using only one RT to screen and a second RT to confirm (without WB) would have had nearly the same accuracy. Discrepant RT results are best evaluated with nucleic acid testing, which would also increase sensitivity.

Sol-Gel processing of silica nanoparticles and their applications.

Recently, silica nanoparticles (SNPs) have drawn widespread attention due to their applications in many emerging areas because of their tailorable morphology. During the last decade, remarkable efforts have been made on the investigations for novel processing methodologies to prepare SNPs, resulting in better control of the size, shape, porosity and significant improvements in the physio-chemical properties. A number of techniques available for preparing SNPs namely, flame spray pyrolysis, chemical vapour deposition, micro-emulsion, ball milling, sol-gel etc. have resulted, a number of publications. Among these, preparation by sol-gel has been the focus of research as the synthesis is straightforward, scalable and controllable. Therefore, this review focuses on the recent progress in the field of synthesis of SNPs exhibiting ordered mesoporous structure, their distribution pattern, morphological attributes and applications. The mesoporous silica nanoparticles (MSNPs) with good dispersion, varying morphology, narrow size distribution and homogeneous porous structure have been successfully prepared using organic and inorganic templates. The soft template assisted synthesis using surfactants for obtaining desirable shapes, pores, morphology and mechanisms proposed has been reviewed. Apart from single template, double and mixed surfactants, electrolytes, polymers etc. as templates have also been intensively discussed. The influence of reaction conditions such as temperature, pH, concentration of reagents, drying techniques, solvents, precursor, aging time etc. have also been deliberated. These MSNPs are suitable for a variety of applications viz., in the drug delivery systems, high performance liquid chromatography (HPLC), biosensors, cosmetics as well as construction materials. The applications of these SNPs have also been briefly summarized.

Effectiveness of flowable resin composite in reducing microleakage - an in vitro study.

BACKGROUND: This study aimed to evaluate the microleakage, when flowable composite is used as a restorative material and a liner. MATERIALS AND METHODS: Forty, non-carious, extracted human premolar teeth were used and they were divided into five groups according to the type of composite material used. Group I: Hybrid composite was inserted and cured for 40 s. Group II: Flowable resin composite which was cured for 40 s. Group III: A thin layer of flowable composite was used to line the axial wall of cavity, over that hybrid composite was inserted and cured for 40 s. Group IV: A thin layer of flowable composite was lined on the axial wall of cavity; over that a packable composite was inserted and cured for 40 s. Group V: Group V was a control group. These cavities were not etched and bonded. They were restored with resin modified glass ionomer cement. After thermocycling and dye immersion, each tooth sectioned longitudinally. Each restoration was observed under a binocular stereomicroscope with magnifying loop of ×12 for microleakage. RESULTS: The results of the study indicate that there was minimum leakage at the enamel margin of all groups. In every group, the leakage at the dentin margin was more than that at the enamel margin. The difference was statistically significant in hybrid and flowable composite (P values are 0.29 and 0.289, respectively). CONCLUSION: Similar leakage values were shown by Groups I and II, indicating that flowable and hybrid composites performed equally well in terms of microleakage. The use of flowable composite as a liner under hybrid and packable composite have shown a trend toward less leakage compared to hybrid and flowable composite alone. How to cite the article: Lokhande NA, Padmai AS, Rathore VP, Shingane S, Jayashankar DN, Sharma U. Effectiveness of flowable resin composite in reducing microleakage - An in vitro Study. J Int Oral Health 2014;6(3):111-4.

Workshop summary: Novel biomarkers for HIV incidence assay development.

Reliable methods for measuring human immunodeficiency virus (HIV) incidence are a high priority for HIV prevention. They are particularly important to assess the population-level effectiveness of new prevention strategies, to evaluate the community-wide impact of ongoing prevention programs, and to assess whether a proposed prevention trial can be performed in a timely and cost-efficient manner in a particular population and setting. New incidence assays and algorithms that are accurate, rapid, cost-efficient, and can be performed on easily-obtained specimens are urgently needed. On May 4, 2011, the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), sponsored a 1-day workshop to examine strategies for developing new assays to distinguish recent from chronic HIV infections. Participants included leading investigators, clinicians, public health experts, industry, regulatory specialists, and other stakeholders. Immune-based parameters, markers of viral sequence diversity, and other biomarkers such as telomere length were evaluated. Emerging nanotechnology and chip-based diagnostics, including algorithms for performing diverse assays on a single platform, were also reviewed. This report summarizes the presentations, panel discussions, and the consensus reached for pursuing the development of a new generation of HIV incidence assays.

Effect of prenatal and perinatal antibiotics on maternal health in Malawi, Tanzania, and Zambia.

OBJECTIVE: We assessed the effect of prenatal and peripartum antibiotics on maternal morbidity and mortality among HIV-infected and uninfected women. METHODS: A multicenter trial was conducted at clinical sites in 4 Sub-Saharan African cities: Blantyre and Lilongwe, Malawi; Dar es Salaam, Tanzania; and Lusaka, Zambia. A total of 1558 HIV-infected and 271 uninfected pregnant women who were eligible to receive both the prenatal and peripartum antibiotic/placebo regimens were enrolled. Pregnant women were interviewed at 20-24 weeks of gestation and a physical examination was performed. Women were randomized to receive either antibiotics or placebo. At the 26-30 week visit, participants were given antibiotics or placebo to be taken every 4 hours beginning at the onset of labor and continuing after delivery 3 times a day until a 1-week course was completed. Logistic regression and Cox proportional hazards models were used. RESULTS: There were no significant differences between the antibiotic and placebo groups for medical conditions, obstetric complications, physical examination findings, puerperal sepsis, and death in either the HIV-infected or the uninfected cohort. CONCLUSION: Administration of study antibiotics during pregnancy had no effect on maternal morbidity and mortality among HIV-infected and uninfected pregnant women.

Primary HIV-1 infection among infants in sub-Saharan Africa: HPTN 024.

OBJECTIVES: Our objectives were to assess clinical signs and diagnoses associated with primary HIV-1 infection among infants. METHODS: We analyzed data from a clinical trial (HIV Prevention Trials Network Protocol 024) in sub-Saharan Africa. Study visits were conducted at birth, at 4-6 weeks, and at 3, 6, 9, and 12 months. The study population comprised live born, singleton, first-born infants of HIV-1-infected women with negative HIV-1 RNA assays who were still breastfeeding at 4-6 weeks. RESULTS: Of 1317 HIV-1-exposed infants, 84 became HIV-1 infected after 4-6 weeks and 1233 remained uninfected. There were 102 primary and 5650 nonprimary infection visits. The most common signs were cough and diarrhea, and the most common diagnoses were malaria and pneumonia. Primary infection was associated with significantly increased odds of diarrhea [odds ratio (OR) = 2.4], pneumonia (OR = 3.5), otitis media (OR = 3.1), and oral thrush (OR = 2.9). For the clinical signs and diagnoses evaluated, sensitivity was low (1%-16.7%) and specificity was high (88.2%-99%). Positive predictive values ranged from 0.1%-1.4%. Negative predictive values ranged from 28.0%-51.1%. CONCLUSIONS: Certain clinical signs and diagnoses, although more common during primary HIV-1 infection, had low sensitivity and high specificity. Efforts to expand access to laboratory assays for the diagnosis of primary HIV-1 infection among infants of HIV-1-infected women should be emphasized.

Placental malaria and mother-to-child transmission of human immunodeficiency virus-1.

There are few studies of the association between placental malaria (PM) and mother-to-child transmission (MTCT) of human immunodeficiency virus-1 (HIV-1), and the results of published studies are inconsistent. To determine the association between PM and MTCT of HIV-1, we performed a secondary analysis of data from a clinical trial of antibiotics to reduce chorioamnionitis. Data regarding 1,662 HIV-1-infected women with live born singleton and first-born twin infants with information regarding PM and infant HIV-1 infection status at birth were analyzed. At the time of the study, women did not have access to antiretroviral drugs for treatment of acquired immunodeficiency syndrome but had received nevirapine prophylaxis to reduce the risk of MTCT of HIV-1. Placental malaria was not associated with the infant HIV-1 infection status at birth (P = 0.67). Adjustment for maternal plasma viral load and CD4+ cell count did not change these results (odds ratio = 1.06, 95% confidence interval = 0.51-2.20, P = 0.87). Placental malaria was more likely to be related to HIV-1 infection at birth among women with low viral load at baseline (P for interaction = 0.08). In conclusion, PM was not associated with infant HIV-1 infection status at birth. The interaction of maternal plasma viral load, PM, and MTCT of HIV-1 warrants further studies.

Determining an optimal testing strategy for infants at risk for mother-to-child transmission of HIV-1 during the late postnatal period.

OBJECTIVES: To determine the optimal time for a second HIV-1 nucleic acid amplification assay to detect late postnatal transmission of HIV-1 (first negative test at 4-8 weeks of age) in resource-limited settings. DESIGN: A longitudinal analysis of data from HIV Prevention Trial Network trial 024. METHODS: Children born to HIV-1-infected mothers enrolled in the HIV Prevention Trial Network trial 024 were tested for HIV-1 infection at six intervals within the first year of life. Mothers and infants received nevirapine prophylaxis. We estimated the probability of being alive and having a positive test in each interval after 4-8 weeks and at 30 days after weaning, conditional on having acquired HIV during the late postnatal period. The interval with the highest probability was taken to be the optimal visit interval. RESULTS: A total of 1609 infants from HIV Prevention Trial Network trial 024 had at least one HIV-1 diagnostic test and were included in the analysis. We found that testing at 1 month after weaning or 12 months of age (whichever comes first) identified 81% of those infected during the late postnatal period (after 4-8 weeks) through breastfeeding. In total, 93% (95% confidence interval 89, 98) of all infected infants would be detected if tests were performed at these two time points. CONCLUSION: In resource-limited settings, HIV-1 PCR testing at 4-8 weeks followed by a second test at 1 month after weaning or at 1 year of age (whichever comes first), led to the identification of the vast majority of HIV-1-infected infants.

Outcome of 234 pregnancies in 140 renal transplant recipients from five middle eastern countries.

OBJECTIVE: To study the pregnancy and offspring outcomes in postrenal transplant recipients. METHODS: This is a retrospective case-note review study investigating the outcome of 234 pregnancies in 140 renal transplant recipients from five different Middle Eastern countries. RESULTS: Of the overall pregnancies 74.4% were successful albeit with high prevalences of preterm and Caesarean deliveries (40.8% and 53%, respectively). The mean serum creatinine did not rise significantly during pregnancy in the group as a whole but did so in patients who had serum creatinine of or above 150 micromol/L at the beginning of their pregnancies. The mean birth weight was (2,458 g) with 41.3% of the newborns being of low birth weight (<2,500 g). The prevalences of stillbirths were 7.3% and of spontaneous abortion was 19.3%. Preeclampsia and gestational diabetes were observed in 26.1% and 2% of pregnancies, respectively. CONCLUSIONS: In the presence of good allograft function, the majority of pregnancies in renal transplant recipients have a good outcome but with increased incidence of preeclampsia, reduced gestational age, and low birth weights. Patients with baseline serum creatinine of above 150 micromol/L have an increased risk of allograft dysfunction resulting from the pregnancy.

Maternal mortality at B P Koirala Institute of Health Sciences, Nepal: review of 6 years.

This study aimed to find out the maternal mortality rate (MMR) in mothers dying after admission to the gynaecology and obstetrics ward of BP Koirala Institute of Health Sciences, Nepal, and to analyse the most common causative factor. There was a total of 58 mortality cases in 6 years.The MMR in 1997--1998 was 12/100,000 live births, in 1998--1999 144/100,000, in 1999--2000 294/100,000, in 2000--2001 450/100,000, in 2001--2002 546/100,000 and in 2002--2003 400/100,000. The most common cause of death was septic-induced abortion and its complications, followed by eclampsia and puerperal sepsis.

Microbial and cytopathological study of intrauterine contraceptive device users.

CONTEXT: Intrauterine contraceptive device (IUCD) is a commonly used birth-spacing method which is fitted into maternal system. Clinical, microbial and cytopathological monitoring of women using these devices are important for ascertaining their side effects, risk of genital tract infection and carcinogenic potential. AIMS: To study clinical, microbial and cytopathological changes in IUCD users in a tertiary care hospital. DESIGN: Prospective analytic. SETTING: Tertiary hospital. MATERIAL AND METHODS: women visiting Family Planning clinic for follow up (IUCD users, n=100) or for IUCD insertion (controls, n=50) were enrolled in the study. Each subject underwent detailed history, general physical, systemic, and per local examination. Vaginal discharge was subjected to pH testing, KOH and wet mount examination, gram staining, and for culture and sensitivity. Bacterial vaginosis was defined using Nugent criteria. Cervical smears were examined and reported as per Bethesda system. STATISTICAL ANALYSIS: The information was entered into Microsoft Excel spreadsheet. The results were analyzed using EPI Info version-6 and Stata statistical software version 7 packages. Two-tailed t-test, chi2 test with Yates correction and two-tailed Fisher Exact tests were applied. RESULTS: Most women used CuT 200 (92%). Median duration of use was 2 years. Chief complaints of IUCD users included backache (54%), vaginal discharge (46%), pain lower abdomen (34%), dyspareunia (22%), menorrhagia (18%) and dysmenorrhea (14%). Mean hemoglobin was lower in IUCD users than controls (11.2+/-1.7 versus 11.9+/-1.8 g/dL, p 0.02). Proportion of women with anemia was higher in IUCD users than in controls (29% versus 16%, p 0.12). Cervical erosion was significantly increased in study group as compared the controls (20% versus 0%, p=0.00) whereas only insignificant increase in vaginitis (6% versus 0%, p=0.17). Trichomonas vaginalis and fungal hyphae positivity and gram stain findings and bacterial vaginosis rate were not significantly different in two groups. Vaginal discharge bacterial culture revealed comparable results in two groups. Cytological findings were predominantly inflammatory. None of cases revealed Actinomycosis infection. High-grade squamous intraepithelial lesion (n=2) and low grade squamous intraepithelial lesion (n=1) cytological finding were present in IUCD users compared to none in controls. None of the cases had any malignant transformation. CONCLUSION: IUCD use results in lower hemoglobin concentration and cervical erosion. Women using IUCD requires a regular follow up, clinical examination, counseling and further investigation if required.

Impact of changes in viral marker screening assays.

BACKGROUND: Monitoring the performance of routinely used infectious disease serologic tests is necessary to evaluate their effectiveness in identifying true-positive units and erroneously disqualifying safe blood donors. METHODS: With two large screening test data sets collected between 1991 and 1998 and between 1997 and 2000, the impact of changes in screening assays for HIV, HCV, and HBsAg was analyzed with regard to the prevalence of confirmed-positive, indeterminate, and confirmed-negative results and the deferral of donors with an indeterminate or negative results (donor loss). RESULTS: The prevalence of indeterminate results and donors loss increased significantly in the 6 months after introduction of an HIV-1/2 EIA. A second-generation HCV EIA increased the detection of confirmed-positive donations in repeat donors (p < 0.001) and increased the prevalence of indeterminate donations. Implementation of a third-generation HCV EIA resulted in a significant decrease in indeterminate results in first-time donors. Nonspecific test results increased when HBsAg test kits from a different manufacturer were introduced or different lots of HIV antibody screening test kits from the same manufacturer were used. CONCLUSION: Introduction of newly licensed versions of assays, switching kit manufacturers, and lot-to-lot variations have an impact on rates of deferrals of safe donors as well as sensitivity of routine screening. Before considering changes in screening tests, blood centers should be aware of, and evaluate, the potential impact on donor loss.

Diagnostic criteria for Tuberculous Meningitis.

OBJECTIVE: Tuberculous Meningitis is associated with a high morbidity and mortality if there is a delay in diagnosis. The diagnosis is based on clinical evaluation since the bacteriological diagnosis takes time and has a low yield. This study attempts to validate these criteria in children with TBM. METHODS: Forty-two children clinically suspected to have TBM were enrolled in the study. History, examination, CT scan and CSF findings were utilized to categorize patients into "definite", "highly probable", "probable" and "possible" TBM based on the criteria laid down by Ahuja et al. The validity of these criteria was tested against bacterial isolation and response to treatment. RESULTS: Thirty one children, with complete data, were included for analysis. Using "improvement on therapy as a criterion for definite TBM, we analyzed the sensitivity and specificity of the Ahuja criteria in diagnosing TBM. Using the criteria of "highly probable" TBM, the sensitivity was 65% with a specificity of 75%. When the criteria of "probable" TBM were used, the sensitivity increased to 96% while the specificity dropped to 38%. In an attempt to make these criteria more appropriate for children, we modified the criteria by including mantoux reaction, and family history of exposure in the criteria. The modified criteria gave a sensitivity of 83% and a specificity of 63%. DISCUSSION: A sensitivity of 65% (highly probable group) implies that 35% of TBM patients will be missed, while the probable criteria gave a 63% false positive rate suggesting that the trade-off for a higher sensitivity makes the criteria very unreliable. Our modification of the criteria gave us a reasonable sensitivity of 83% with a higher specificity of 63%. The false positive rate was also reduced to 38%. Thus the modified Ahuja criteria worked better for children with TBM. CONCLUSION: The modified Ahuja criteria are better applicable for use in pediatric patients with TBM . Since the number of patients was small in this study, the study needs to be validated with a larger sample size.