scholarly journals Screening Pregnant Women for Bacterial Vaginosis Using a Point-of-Care Test: A Prospective Validation Study

2021 ◽  
Vol 10 (11) ◽  
pp. 2275
Author(s):  
Philipp Foessleitner ◽  
Herbert Kiss ◽  
Julia Deinsberger ◽  
Julia Ott ◽  
Lorenz Zierhut ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Bacterial Vaginosis ◽  
Pregnant Women ◽  
Predictive Value ◽  
Screening Tool ◽  
Point Of Care ◽  
Sialidase Activity ◽  
Point Of Care Test ◽  
Gram Staining ◽  
Increased Risk

Bacterial vaginosis in early pregnancy is associated with an increased risk of preterm birth. The introduction of a simple screen-and-treat program into antenatal care was shown to significantly reduce the rate of preterm birth. The gold standard for diagnosing bacterial vaginosis is Gram staining, which is, however, time-consuming and requires laboratory facilities. The objective of this prospective study was to validate a point-of-care sialidase activity detection test (OSOM® BVBLUE® Test) for asymptomatic pregnant women and evaluate its accuracy as a screening tool. We enrolled 200 pregnant participants, 100 with Gram staining-confirmed bacterial vaginosis and 100 healthy controls. Compared to Gram staining, the point-of-care test showed a sensitivity of 81%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 98.1%. In conclusion, we found that the OSOM® BVBLUE® Test was an accurate method for diagnosing bacterial vaginosis in asymptomatic pregnant women. This point-of-care test can therefore be considered a reliable and easy-to-use screening tool for bacterial vaginosis during pregnancy.

scholarly journals Validation of the SavvyCheckTM Vaginal Yeast Test for Screening Pregnant Women for Vulvovaginal Candidosis: A Prospective, Cross-Sectional Study

2021 ◽  
Vol 7 (3) ◽  
pp. 233
Author(s):  
Philipp Foessleitner ◽  
Herbert Kiss ◽  
Julia Deinsberger ◽  
Julia Ott ◽  
Lorenz Zierhut ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Predictive Value ◽  
Point Of Care ◽  
Cross Sectional Study ◽  
Control Group ◽  
Gram Stain ◽  
Cross Sectional ◽  
Point Of Care Test ◽  
Increased Risk ◽  
Vulvovaginal Candidosis

Pregnant women have an increased risk of vulvovaginal candidosis. Recurrent candidosis is under debate as a contributor to preterm birth, and vertical transmission may cause diaper dermatitis and oral thrush in the newborn. Apart from cultural methods, the gold standard for diagnosing candidosis is Gram staining, which is time-consuming and requires laboratory facilities. The objective of this prospective study was to validate a point-of-care vaginal yeast detection assay (SavvyCheckÔ Vaginal Yeast Test) and to evaluate it in asymptomatic pregnant women. We enrolled 200 participants, 100 of whom had vulvovaginal candidosis according to Gram stain (study group) and 100 were healthy pregnant controls (control group). Of these, 22 participants (11%) had invalid test results. The point-of-care test of the remaining 85 and 93 study participants in the study and control groups, respectively, showed a sensitivity of 94.1%, specificity of 98.9%, positive predictive value of 90.3%, and negative predictive value of 99.4% when compared with Gram stain. In conclusion, we found a high correlation between the SavvyCheckÔ Vaginal Yeast Test and Gram-stained smears during pregnancy. This suggests a potential role of this point-of-care test as a screening tool for asymptomatic pregnant women in early gestation.

Diagnostic evaluation of the BD Affirm VPIII assay as a point-of-care test for the diagnosis of bacterial vaginosis, trichomoniasis and candidiasis

2020 ◽  
Vol 31 (4) ◽  
pp. 303-311
Author(s):  
Fazana Dessai ◽  
Makandwe Nyirenda ◽  
Motshedisi Sebitloane ◽  
Nathlee Abbai
Keyword(s):  
Bacterial Vaginosis ◽  
Predictive Value ◽  
Trichomonas Vaginalis ◽  
Point Of Care ◽  
Candida Spp ◽  
Vaginal Infections ◽  
Sexually Transmitted ◽  
Point Of Care Test ◽  
Mother And Child ◽  
Sensitivity Specificity

Untreated sexually transmitted infections and bacterial vaginosis (BV) pose a serious health risk to mother and child. Limited data exist on the use of the BD Affirm™ VPIII assay as a point-of-care test (POCT). The performance of the BD Affirm™ VPIII assay was compared with the BD Max™ vaginal assay for the diagnosis of BV, Trichomonas vaginalis (TV) and Candida spp. A total of 273 pregnant women were enrolled in this study and had provided two self-collected vaginal swabs. Sensitivity, specificity, positive predictive value, negative predictive value and prevalence were calculated. The prevalence of BV, candidiasis and trichomoniasis was 49.4, 57.2 and 10.3%, respectively. The BD Affirm™ VPIII assay showed a moderate sensitivity (79.8%) and a moderate specificity (80.3%) for diagnosing BV in all participants. The BD Affirm™ VPIII assay had an excellent specificity for Candida spp. and TV of 97.4 and 100%, respectively; however, the assay exhibited poor sensitivities of 52.9 and 46.4%, respectively. This study was the first to report on the performance of the BD Affirm™ VPIII assay as a POCT in an antenatal population. The assay was found to be unsuitable as a screening test for vaginal infections in pregnancy.

scholarly journals A Comparison of Colorimetric Assessment of Vaginal pH with Nugent Score for the Detection of Bacterial Vaginosis

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Matthew K. Hoffman ◽  
Mrutyunjaya B. Bellad ◽  
Umesh S. Charantimath ◽  
Avinash Kavi ◽  
Jyoti M. Nagmoti ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Predictive Value ◽  
Point Of Care ◽  
Controlled Trial ◽  
Intraclass Correlation ◽  
Point Of Care Testing ◽  
Nugent Score ◽  
Randomized Controlled ◽  
Gram Staining ◽  
Vaginal Ph

Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV.Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two independent blinded microbiologists for Nugent scoring.Results. Interrater reliability of the interpretation of the Nugent score was excellent (intraclass correlation-individual 0.93 (95 CI 0.92 to 0.94) and average 0.96 (95% CI 0.95 to 0.97)). The sensitivity of an elevated pH > 5 for a Nugent score > 7 was 21.9% while the specificity was 84.5%. The positive predictive value in our population was 33.7% with a negative predictive value of 75.0%.Conclusion. Though the Nugent score is internally accurate, the prediction of BV using vaginal pH alone has poor sensitivity and specificity.

scholarly journals NESTROFT—A Cost-Effective Mass Screening Tool for the Detection of β-Thalassemia Carrier Status in Anemic Pregnant Women: A Step Toward Reducing the National Disease Burden

2021 ◽  
Author(s):  
Manasi Gosavi ◽  
Ramesh Chavan ◽  
M. B. Bellad
Keyword(s):  
Pregnant Women ◽  
Effective Mass ◽  
Mass Screening ◽  
Predictive Value ◽  
Screening Tool ◽  
Hematological Parameters ◽  
False Negative ◽  
Cost Effective ◽  
Mean Corpuscular Hemoglobin ◽  
Carrier Status

Abstract Introduction β-Thalassemias are inherited hemoglobinopathies commonly encountered in practice. With chances of a promising cure being rare, the prevention of births with this disorder should assume priority, especially in low-resource countries. This can be achieved by the implementation of a mass screening program that is reliable and, at the same time, cost-effective. Objectives This study focuses on the utility of Naked Eye Single Tube Red Cell Osmotic Fragility Test (NESTROFT) as a mass screening tool to detect thalassemia carriers. Hematological parameters that may predict carrier status were also evaluated. Materials and Methods Hemoglobin estimation was performed on all consented pregnant women. If the patient was found to have hemoglobin < 11 g/dL, the blood sample was subjected to other routine hematological tests along with peripheral smear examination. NESTROFT was performed using 0.36% saline solution. Confirmation was done using high-performance liquid chromatography (HPLC). Statistical Analysis Data obtained were tabulated using version 21 of the Statistical Package for Social Sciences. Means, standard deviations, and percentages were used to describe the sample. Chi-square test and Students’ “t” test were used to identify differences between the groups. Results Of 441 pregnant women enrolled, 206 were found to be anemic. Nineteen (9.2%) of the anemic pregnant women were detected to be carriers of hemoglobinopathies. Among the hematological parameters, mean red blood cell count and reticulocyte count were higher, while mean corpuscular hemoglobin concentration was lower in carriers. Also, carriers were more likely to present with microcytic hypochromic anemia. NESTROFT showed a sensitivity of 84.21%, specificity of 96.25%, a positive predictive value of 69.56%, and a negative predictive value of 98.36%. A false-positive result was seen in 3.74% of the tests, while a false negative result was seen in 15.78% of the tests. Conclusions NESTROFT (0.36%) can be used as a simple and cost-effective mass screening tool for the detection of carrier status. This should be followed by confirmation using HPLC or hemoglobin electrophoresis.

scholarly journals Two serological approaches for detection of antibodies to SARS-CoV-2 in different scenarios: a screening tool and a point-of-care test

2020 ◽  
Vol 98 (4) ◽  
pp. 115167 ◽  
Author(s):  
Alexis C.R. Hoste ◽  
Angel Venteo ◽  
Alba Fresco-Taboada ◽  
Istar Tapia ◽  
Alejandro Monedero ◽  
...  
Keyword(s):  
Screening Tool ◽  
Point Of Care ◽  
Point Of Care Test

scholarly journals AnemoCheck-LRS: an optimized, color-based point-of-care test to identify severe anemia in limited-resource settings

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Marina S. Perez-Plazola ◽  
Erika A. Tyburski ◽  
Luke R. Smart ◽  
Thad A. Howard ◽  
Amanda Pfeiffer ◽  
...  
Keyword(s):  
Screening Tool ◽  
Point Of Care ◽  
Low Cost ◽  
Limited Resource ◽  
Absolute Difference ◽  
Severe Anemia ◽  
Detection Range ◽  
Point Of Care Test ◽  
Colour Scale ◽  
Life Saving

Abstract Background Severe anemia is common and frequently fatal for hospitalized patients in limited-resource settings. Lack of access to low-cost, accurate, and rapid diagnosis of anemia impedes the delivery of life-saving care and appropriate use of the limited blood supply. The WHO Haemoglobin Colour Scale (HCS) is a simple low-cost test but frequently inaccurate. AnemoCheck-LRS (limited-resource settings) is a rapid, inexpensive, color-based point-of-care (POC) test optimized to diagnose severe anemia. Methods Deidentified whole blood samples were diluted with plasma to create variable hemoglobin (Hb) concentrations, with most in the severe (≤ 7 g/dL) or profound (≤ 5 g/dL) anemia range. Each sample was tested with AnemoCheck-LRS and WHO HCS independently by three readers and compared to Hb measured by an electronic POC test (HemoCue 201+) and commercial hematology analyzer. Results For 570 evaluations within the limits of detection of AnemoCheck-LRS (Hb ≤ 8 g/dL), the average difference between AnemoCheck-LRS and measured Hb was 0.5 ± 0.4 g/dL. In contrast, the WHO HCS overestimated Hb with an absolute difference of 4.9 ± 1.3 g/dL for samples within its detection range (Hb 4–14 g/dL, n = 405). AnemoCheck-LRS was much more sensitive (92%) for the diagnosis of profound anemia than WHO HCS (22%). Conclusions AnemoCheck-LRS is a rapid, inexpensive, and accurate POC test for anemia. AnemoCheck-LRS is more accurate than WHO HCS for detection of low Hb levels, severe anemia that may require blood transfusion. AnemoCheck-LRS should be tested prospectively in limited-resource settings where severe anemia is common, to determine its utility as a screening tool to identify patients who may require transfusion.

scholarly journals A Randomized Controlled Open Label Crossover Trial to Study Vaginal Colonization of Orally Administered Lactobacillus Reuteri RC-14 and Rhamnosus GR-1 in Pregnant Women at High Risk for Preterm Labor

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1141 ◽  
Author(s):  
Enav Yefet ◽  
Raul Colodner ◽  
Merav Strauss ◽  
Yifat Gam Ze Letova ◽  
Zohar Nachum
Keyword(s):  
Preterm Birth ◽  
High Risk ◽  
Bacterial Vaginosis ◽  
Pregnant Women ◽  
Lactobacillus Reuteri ◽  
Bacterial Strains ◽  
Open Label ◽  
Flight Mass Spectrometry ◽  
Vaginal Colonization ◽  
Probiotic Treatment

Lactobacilli administration has been suggested for the treatment and prevention of bacterial vaginosis, which increases the risk for preterm birth. We aimed to evaluate the vaginal colonization of lactobacilli orally administered to pregnant women at risk for preterm birth. We performed a randomized and controlled crossover study between January 2016 and May 2017. Forty pregnant women at high risk for preterm birth with normal vaginal flora (Nugent score ≤ 3) were randomized to either receive two oral capsules/day each containing 5 × 109 Lactobacilli (L.) rhamnosus GR-1 and L. reuteri RC-14 (n = 20) or no treatment (n = 20) for 2 months. Treatments were then crossed over for an additional two months. A vaginal examination and swabbing were performed for assessment of bacterial vaginosis at baseline and every month until study completion. At the same time points, vaginal samples were cultured and subjected to matrix-assisted-laser-desorption/ionization-time-of-flight-mass-spectrometry (MALDI TOF-MS) for the detection of the specific bacterial strains contained in the capsules. The primary endpoint was the presence of the administered lactobacilli strains in the vagina during the first two months of follow-up. Thirty-eight women completed the study. During the first two months of treatment, L. rhamnosus GR-1 was detected in one (5%) woman on the probiotic treatment and 2 (11%) women receiving no treatment (p = 0.6). L. rhamnosus GR-1 was detected in vaginal samples of 4 (11%) women during probiotic treatment (of both groups) and L. reuteri RC-14 was not detected in any samples. The rest of the endpoints were not different between the groups. Altogether, vaginal colonization of lactobacilli following oral administration is low during pregnancy.

scholarly journals Perinatal Outcomes in HIV Positive Pregnant Women with Concomitant Sexually Transmitted Infections

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Erin Burnett ◽  
Tammy L. Loucks ◽  
Michael Lindsay
Keyword(s):  
Preterm Birth ◽  
Prenatal Care ◽  
Pregnant Women ◽  
Perinatal Outcomes ◽  
Neonatal Outcomes ◽  
Hiv Positive ◽  
City Hospital ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Increased Risk

Objective. To evaluate whether HIV infected pregnant women with concomitant sexually transmitted infection (STIs) are at increased risk of adverse perinatal and neonatal outcomes.Methods. We conducted a cohort study of HIV positive women who delivered at an inner-city hospital in Atlanta, Georgia, from 2003 to 2013. Demographics, presence of concomitant STIs, prenatal care information, and maternal and neonatal outcomes were collected. The outcomes examined were the association of the presence of concomitant STIs on the risk of preterm birth (PTB), postpartum hemorrhage, chorioamnionitis, preeclampsia, intrauterine growth restriction, small for gestational age, low Apgar scores, and neonatal intensive care admission. Multiple logistic regression was performed to adjust for potential confounders.Results. HIV positive pregnant women with concomitant STIs had an increased risk of spontaneous PTB (odds ratio (OR) 2.11, 95% confidence interval [CI] 1.12–3.97). After adjusting for a history of preterm birth, maternal age, and low CD4+ count at prenatal care entry the association between concomitant STIs and spontaneous PTB persisted (adjusted OR 1.96, 95% CI 1.01–3.78).Conclusions. HIV infected pregnant women with concomitant STIs relative to HIV positive pregnant women without a concomitant STI are at increased risk of spontaneous PTB.

scholarly journals Reliability of conventional Papanicolaou smear in diagnosing bacterial vaginosis among women with clinical genital infection

2020 ◽  
Vol 09 (01) ◽  
pp. 13-16
Author(s):  
Kavita Vivek Anand ◽  
Sharmila Anil Pimple ◽  
Gauravi A. Mishra ◽  
Rupali V. Sahare ◽  
Saleem Pathuthara ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Bacterial Vaginosis ◽  
Sensitivity And Specificity ◽  
Predictive Value ◽  
Pap Smear ◽  
Screening Tool ◽  
Genital Infection ◽  
Gram Stain ◽  
Nugent Score ◽  
Reproductive Tract Infection

Abstract Objective: Bacterial vaginosis (BV) is a common reproductive tract infection (RTI) reported among Indian women. BV can influence the persistence of high-risk oncogenic human papillomavirus, a causative factor for cervical cancer. BV and cervical cancer are major public health issues in a developing country like India. It becomes important for a resource-constrained country like India with poor healthcare access to implement control measures to screen and treat RTI in an attempt to prevent the risk for cervical cancer. Papanicolaou (Pap) smear is an established screening tool for cervical cancer and the diagnosis of RTIs, forms a part of its evaluation. The present study explores the validity of conventional Pap smear in diagnosing BV. Methodology: Pap smear and Gram stain smear were collected for 254 women with clinically evident cervicitis/cervicovaginitis (genital infection). Using the Nugent score on Gram stain as a gold standard, we determined the sensitivity and specificity of Pap smear to diagnose BV. Results: The overall prevalence of BV in the study population was 44% using the Nugent score. Pap smear showed sensitivity and specificity of 70.9%. (CI- 61.5% - 79.2%) and 56.8% (CI – 48.2%–65.2%), respectively. The positive predictive value of Pap smear to diagnose BV was 56.5% (CI – 47.8%–64.9%), and the negative predictive value was 71.2% (CI – 61.8%–79.4%). Conclusion: In the present study, conventional Pap smear demonstrates good accuracy to detect BV. Pap testing for cervical cancer screening can additionally serve as an effective screening tool for diagnosing BV among women with genital infection in healthcare settings.

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