scholarly journals Field Performance and Diagnostic Accuracy of a Low-Cost Instrument-Free Point-of-Care CD4 Test (Visitect CD4) Performed by Different Health Worker Cadres among Pregnant Women

2018 ◽  
Vol 57 (2) ◽  
Author(s):  
Stanley Luchters ◽  
Karl Technau ◽  
Yasmin Mohamed ◽  
Matthew F. Chersich ◽  
Paul A. Agius ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Pregnant Women ◽  
Health Worker ◽  
Rural Areas ◽  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
Field Performance ◽  
Hiv Care ◽  
Finger Prick

ABSTRACT Measuring CD4 counts remains an important component of HIV care. The Visitect CD4 is the first instrument-free low-cost point-of-care CD4 test with results interpreted visually after 40 min, providing a result of ≥350 CD4 cells/mm3. The field performance and diagnostic accuracy of the test was assessed among HIV-infected pregnant women in South Africa. A nurse performed testing at the point-of-care using both venous and finger-prick blood, and a counselor and laboratory staff tested venous blood in the clinic laboratory (four Visitect CD4 tests/participant). Performance was compared to the mean CD4 count from duplicate flow cytometry tests on venous blood (FACSCalibur Trucount). In 2017, 156 patients were enrolled, providing a total of 624 Visitect CD4 tests (468 venous and 156 finger-prick samples). Of 624 tests, 28 (4.5%) were inconclusive. Generalized linear mixed modeling showed better performance of the test on venous blood (sensitivity = 81.7%; 95% confidence interval [CI] = 72.3 to 91.1]; specificity = 82.6%, 95% CI = 77.1 to 88.1) than on finger-prick specimens (sensitivity = 60.7%; 95% CI = 45.0 to 76.3; specificity = 89.5%, 95% CI = 83.2 to 95.8; P = 0.001). No difference in performance was detected by cadre of health worker (P = 0.113) or between point-of-care versus laboratory-based testing (P = 0.108). Adequate performance of Visitect CD4 with different operators and at the point of care, with no need of electricity or instrument, shows the potential utility of this device, especially for facilitating decentralization of CD4 testing services in rural areas.

scholarly journals Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT®CD4) for use in resource-limited settings

2020 ◽  
Vol 48 (9) ◽  
pp. 030006052095502
Author(s):  
Vairamohan Vidhyavathi ◽  
Hussain Syed Iqbal ◽  
Kannaiyan Kanthamani ◽  
Sunil Suhas Solomon ◽  
Paneerselvam Nandagopal ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Predictive Value ◽  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
Hiv Positive ◽  
Resource Limited ◽  
Immunodeficiency Virus ◽  
Finger Prick ◽  
Sensitivity Specificity

Objective CD4+ T lymphocyte count remains the most common biomarker of immune status and disease progression in human immunodeficiency virus (HIV)-positive individuals. VISITECT®CD4 is an instrument-free, low-cost point-of-care CD4 test with a cut-off of 350 CD4 cells/μL. This study aimed to evaluate VISITECT®CD4 test's diagnostic accuracy. Methods Two hundred HIV-positive patients attending a tertiary HIV centre in South India were recruited. Patients provided venous blood for reference and VISITECT®CD4 tests. An additional finger-prick blood sample was obtained for VISITECT®CD4. VISITECT®CD4's diagnostic performance in identifying individuals with CD4 counts ≤350 cells/μL was assessed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking flow cytometry as the reference. Results The overall agreement between VISITECT®CD4 and flow cytometry was 89.5% using venous blood and 81.5% using finger-prick blood. VISITECT®CD4 showed better performance using venous blood [sensitivity: 96.6% (95% confidence interval: 92.1%–98.9%), specificity: 70.9% (57.1%–82.4%), PPV: 89.7% (83.9%–94.0%) and NPV: 88.6% (75.4%–96.2%)] than using finger-prick blood [sensitivity: 84.8% (77.9%–90.2%), specificity: 72.7% (59.0%–83.9%), PPV: 89.1% (82.7%–93.8%) and NPV: 64.5% (51.3%–76.3%)]. Conclusion VISITECT®CD4 performed well using venous blood, demonstrating its potential utility in decentralization of CD4 testing services in resource-constrained settings.

scholarly journals Intermittent preventive treatment for malaria in pregnancy: Is directly observed therapy still necessary? A prospective cohort study in a tertiary hospital, Southern Nigeria

2020 ◽  
Vol 4 ◽  
pp. 34-39
Author(s):  
Ubong Akpan ◽  
Udeme Asibong ◽  
Zibrin Okhormbe ◽  
Mabel Ekott ◽  
Saturday Etuk
Keyword(s):  
Cohort Study ◽  
Pregnant Women ◽  
Rural Areas ◽  
Venous Blood ◽  
Intermittent Preventive Treatment ◽  
Preventive Treatment ◽  
Tertiary Hospital ◽  
Control Group ◽  
Directly Observed Therapy ◽  
In Pregnancy

Objective: Malaria is a major cause of indirect maternal death. In the last two decades several efforts have been made to combat the menace of this disease especially among pregnant women and children in developing countries. Directly observed therapy (DOT) was recommended to enhance the uptake of intermittent preventive treatment (IPT) of malaria with sulfadoxine – pyrimethamine among pregnant women. Due to challenges involved in the practice of DOT especially with regards to shortage of man power and clean water in rural areas, there is need to evaluate impact of DOT on the effectiveness of treatment. Material and Methods: A cohort study was carried out among 320 healthy pregnant women receiving ante natal care with equal assignment of subjects. The study group (160) received two doses of IPT by DOT while 160 matched controls were given prescription for self- drug administration at home. Malaria tests were done using microscopy method and the hemoglobin values determined using centrifuge one month after the second dose of IPT. Umbilical cord blood samples were obtained for a repeat microscopy at delivery. Results: The results showed that there were no statistical significant differences in the venous blood parasitemia, placental parasitemia and anaemia between the DOT group and the control group (P = 0.215; P = 0.100; P = 0.966) respectively. Lower social class was the main predictor of anaemia in pregnancy (P = 0.032). Conclusion: The delivery of IPT through DOT may not influence uptake in some settings. Effort may need to be channeled into ante natal education and women empowerment.

scholarly journals Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial

2016 ◽  
Vol 54 (4) ◽  
Author(s):  
Alexander Kutz ◽  
Pierre Hausfater ◽  
Michael Oppert ◽  
Murat Alan ◽  
Eva Grolimund ◽  
...  
Keyword(s):  
Emergency Department ◽  
Diagnostic Accuracy ◽  
Whole Blood ◽  
Point Of Care ◽  
Venous Blood ◽  
Reference Method ◽  
Point Of Care Test ◽  
Emergency Department Patients ◽  
Work Up

AbstractProcalcitonin (PCT) is increasingly being used for the diagnostic and prognostic work up of patients with suspected infections in the emergency department (ED). Recently, B·R·A·H·M·S PCT direct, the first high sensitive point-of-care test (POCT), has been developed for fast PCT measurement on capillary or venous blood samples.This is a prospective, international comparison study conducted in three European EDs. Consecutive patients with suspicion of bacterial infection were included. Duplicate determination of PCT was performed in capillary (fingertip) and venous whole blood (EDTA), and compared to the reference method. The diagnostic accuracy was evaluated by correlation and concordance analyses.Three hundred and three patients were included over a 6-month period (60.4% male, median age 65.2 years). The correlation between capillary or venous whole blood and the reference method was excellent: rThis study found a high diagnostic accuracy and a faster time to result of B·R·A·H·M·S PCT direct in the ED setting, allowing shortening time to therapy and a more wide-spread use of PCT.

Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia

2020 ◽  
Vol 66 (6) ◽  
pp. 630-636
Author(s):  
Bhargavi Kamineni ◽  
Anusha Tanniru ◽  
Venkateshwarlu Vardhelli ◽  
Deepak Sharma ◽  
Dinesh Pawale ◽  
...  
Keyword(s):  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
P Value ◽  
Moderate Degree ◽  
Cross Sectional ◽  
System A ◽  
The Mean ◽  
Sample Transfer ◽  
Severe Hyperbilirubinemia

Abstract Introduction Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. Objective To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. Design/methods In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. Results Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48–92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 0.457; 95% CI: 0.339–0.561, p value < 0.001). Bland–Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between −8.2 and +9.1 mg/dl. Conclusion Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.

scholarly journals Acceptability and feasibility of dual HIV and syphilis point-of-care testing for early detection of infection among pregnant women in China: a prospective study

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e020717 ◽  
Author(s):  
Qian Wang ◽  
Po-Lin Chan ◽  
Lori M Newman ◽  
Li-Xia Dou ◽  
Xiao-Yan Wang ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Rural Areas ◽  
Point Of Care ◽  
Antenatal Clinic ◽  
Antenatal Visit ◽  
Healthcare Facilities ◽  
Rural And Urban ◽  
Testing Uptake ◽  
Township Hospitals ◽  
A Prospective Study

ObjectiveTo assess the feasibility and acceptability of using WHO prequalified combined dual HIV/syphilis rapid diagnostic tests (RDT) for same-day results in antenatal care (ANC) clinics.MethodsThis is a pragmatic implementation study using quantitative approach to evaluate outcomes. Antenatal clinic attendees from 21 rural and urban township hospitals in two provinces of China were offered with free dual RDTs testing that included HIV and syphilis, in addition to the routine blood tests. Study outcomes included testing uptake before and during dual RDT use, test feasibility and acceptability among pregnant women. Regression model was used to assess acceptance of RDT testing.ResultsIn total, 1787 out of 1828 pregnant women attending ANC received the RDT testing. Testing uptake among pregnant women in their first and second trimester increased from 76.0% (2438/3269) using standard blood testing to 90.1% (1626/1787) with concurrent RDT use (χ2=197.1, p<0.001). Among 1787 pregnant women who received RDT tests, 98.3% (1757/1787) participants were given test result the same day. Positive proportions of HIV and syphilis screened with RDT were 0.06% (1/1787) and 1.0% (18/1787), respectively. Regression analysis indicated that women who did not receive syphilis or HIV testing before were less likely to accept dual RDT (OR 0.28, 95% CI 0.10 to 0.75). Acceptance for dual RDT testing at second or third antenatal visit was lower compared with the first visit (OR 0.37, 95% CI 0.15 to 0.94).ConclusionCombined dual HIV/syphilis RDT with same-day results increased uptake of HIV and syphilis testing among pregnant women at primary healthcare facilities. Given the diversity of testing capacities among health services especially in rural areas in China, the dual RDT kit is feasible tool to improve testing uptake among pregnant women.

scholarly journals Helicobacter pylori infection and hyperemesis gravidarum: a prospective pilot study in India

2019 ◽  
Vol 8 (7) ◽  
pp. 2856
Author(s):  
Akhila M. V. ◽  
Padmasri R.
Keyword(s):  
Socioeconomic Status ◽  
Helicobacter Pylori ◽  
Pregnant Women ◽  
Rural Areas ◽  
Hyperemesis Gravidarum ◽  
Venous Blood ◽  
Tertiary Hospital ◽  
Helicobacter Pylori Infection ◽  
H Pylori ◽  
A Prospective Study

Background: About 80% of all pregnant women experience some form of nausea and vomiting during their pregnancy. Hyperemesis gravidarum, the commonest indication for admission to hospital in the first half of pregnancy affects approximately 0.3%-2.0% of pregnancies. Helicobacter pylori infection has been implicated in the cause of nausea and occasional vomiting in early pregnancy. The objectives of this study are to determine the proportion of H. pylori seropositivity among women with hyperemesis gravidarum (HG) and determine its relation with socio-economic status.Methods: This was a prospective study conducted in a tertiary hospital in Bangalore among 60 pregnant women with HG for a period of 12 months. Venous blood samples were obtained and serum IgG for H. pylori was measured using enzyme-linked immunosorbant assay (ELISA). Details regarding socioeconomic status, recurrence of symptoms and severity were noted.Results: The proportion of H. pylori seropositivity among pregnant women with hyperemesis in our study was 70%.There was a significant increase in severity and recurrence of vomiting among seropositive cases. Women belonging to rural areas had 1.17 times the risk of infection compared to women with urban area. We also found women belonging to the lower socioeconomic status had 0.52 times more risk to develop Helicobacter pylori infection.Conclusions: This study suggests that H. pylori is an independent risk factor for vomiting in pregnancy. Effective treatment and eradication of H pylori infection may help reduce severity and recurrence of vomiting among positive cases thus reducing its adverse consequences.

scholarly journals Syphilis Screening among 27,150 Pregnant Women in South Chinese Rural Areas Using Point-of-Care Tests

PLoS ONE ◽  
2013 ◽  
Vol 8 (8) ◽  
pp. e72149 ◽  
Author(s):  
Li-Gang Yang ◽  
Joseph D. Tucker ◽  
Feng-Ying Liu ◽  
Xu-Qi Ren ◽  
Xuan Hong ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Rural Areas ◽  
Point Of Care ◽  
Syphilis Screening ◽  
Point Of Care Tests

scholarly journals Prevalence and Predictors of Zinc Deficiency among Children and Non-Pregnant Women in Nepal: Analysis of Nepal Micronutrients Status Survey 2016

2020 ◽  
Author(s):  
Suresh Mehata ◽  
Man Kumar Tamang ◽  
Kedar Raj Parajuli ◽  
Binod Rayamajhee ◽  
Uday Narayan Yadav ◽  
...  
Keyword(s):  
Risk Factors ◽  
Vitamin A ◽  
Pregnant Women ◽  
Zinc Deficiency ◽  
Rural Areas ◽  
Venous Blood ◽  
Household Wealth ◽  
Zinc Status ◽  
Markers Of Inflammation ◽  
Status Survey

Zinc deficiency, a common malnutrition in children and women is a global public health problem.Burden of zinc deficiencyis more in countries with low meat and high cereal food consumption like Nepal. Nationally representative data on zinc status in Nepal is lacking at present. This study analysed the data from the recent Nepal National Micronutrient status survey 2016(NNMSS-2016) to determinethe prevalence of zinc deficiency and associated risk factors among children aged 6-59 months (n=1462) and non-pregnant women aged 15-49 years(n=1923) from three ecological zones, Hill, Terai, and Mountainof the country. Venous blood was collected from the participants to measure micronutrients such as zinc, markers of anaemia, vitamin A, and markers of inflammation. Stool was collected to assessthe soil-transmitted helminths (STHs) and Helicobacterpylori infection. Socio-demographic, household and other relevant information were collected by a structured questionnaire. Logistic regression was used to examine the predictors of zinc deficiency among the participants.The overall zinc deficiency in children was found to be 22.9% while it was higher in non-pregnant women (24.7%). Predictors associated with zinc deficiency among enrolled children in the study were,living in rural areas (AOR=2.25, 95% CI, [1.13, 4.49]),occurrence of diarrhoea during the two weeks preceding the survey (AOR=1.57, 95% CI, [1.07, 2.30]), household wealth quintile (AOR= 0.48, 95% CI,[0.25, 0.92]) and vitamin A status (AOR=0.49, 95% CI,[0.28, 0.85]. Risk factors associated with zinc deficiency among the non-pregnant women were being underweight (AOR=1.60, 95% CI,[1.15, 2.23]), fever occurrence during two weeks preceding the survey (AOR=1.45, 95% CI,[ 1.06, 1.99]), H. pylori in the stool (AOR=1.32, 95% CI, [1.03, 1.70]), being rich (AOR=0.64, 95% CI,[0.42, 0.98]) and being in the risk of folate deficiency (AOR=0.60, 95% CI,[0.37, 0.96]). We conclude that community focused intervention programs including health and nutrition counselling and livelihood opportunities focusing groups at high-risk may improve the zinc status in Nepal.

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