scholarly journals Development and evaluation of a Point-of-Care Test (POCT) in a low resource setting with high rates of Chlamydia trachomatis urogenital infections in Fiji

Author(s):  
Deborah Dean ◽  
Sumeetha Swaminathan ◽  
Mike Kama ◽  
Sophie Goemans ◽  
Daniel Faktaufon ◽  
...  

Rapid and precise detection of Chlamydia trachomatis—the leading global cause of sexually transmitted infections (STI)—at the point-of-care (POC) is required for treatment decisions to prevent transmission and sequelae including pelvic inflammatory disease, ectopic pregnancy, tubal-factor infertility and preterm birth. We developed a rapid POC test (POCT), termed LH-POCT, which uses Loop-mediated AMPlification (LAMP) of nucleic acids, and performed a head-to-head comparison with the Cepheid Xpert® CT/NG assay using clinician-collected de-identified paired vaginal samples from a parent study that consecutively enrolled symptomatic and asymptomatic females over age 18 years from the Ministry of Health and Medical Services Health Centers in Fiji. Samples were processed by the Xpert® CT/NG assay and LH-POCT, blinded to the comparator. Discrepant samples were resolved by qPCR. De-identified clinical data and tests for Trichomonas vaginalis, Candida and bacterial vaginosis (BV) were provided. There were a total of 353 samples from 327 females. C. trachomatis positivity was 16.7% (59/353) while the prevalence was 16.82% (55/327) after discrepant resolution. Seven discrepant samples resolved to: four false negatives, two false positives and one true positive for the LH-POCT. The sensitivity of the LH-POCT was 93.65% (95% CI: 84.53% to 98.24%) and specificity 99.31% (95% CI: 97.53% to 99.92%). Discrepant samples clustered among women with vaginal discharge and/or BV. The prototype LH-POCT workflow has excellent performance, meeting many World Health Organization ASSURED criteria for POC tests, including a sample-to-result time of 35 minutes. Our LH-POCT holds promise for improving clinical practice to prevent and control C. trachomatis STIs in diverse health care settings globally.


2019 ◽  
Vol 7 (10) ◽  
pp. 97
Author(s):  
Divakaruni ◽  
Mahabir ◽  
Orrett ◽  
Adidam ◽  
Venkata ◽  
...  

Trichomoniasis is the most common non-viral sexually transmitted disease (STD) globally and yet is not a reportable disease. Trichomonas vaginalis is an important source of reproductive morbidity and may increase risk of acquisition and transmission of human immunodeficiency viruses (HIV). The World Health Organization (WHO) and the Control Disease Center (CDC) recommend various regimens of nitroimidazole s for treatment. The common nitroimidazoles used for trichomoniasis are metronidazole and tinidazole, which vary in their cost, efficacy, and side effect profile. It is relevant to study these factors for better management of the patients. This study aimed to compare and study the efficacy, compliance of various treatment regimens, their outcomes, and side-effects for trichomoniasis, among STI clinic attendees in Trinidad. A clinical trial study was designed, and after obtaining the informed consent, a routine clinical examination was conducted and the swabs for trichomoniasis tests were collected for diagnosis from the 692 participants. Out of 692 participants, 82 patients with positive diagnosis of Trichomonas infection were treated according to the patient’s choice, using different drug regimens. Compliance to treatment, side effects, and outcome were evaluated. The prevalence of trichomoniasis in the population attending our STI clinic is 11.9% and prevalence of HIV is 9%. Of the total 82 participants for the treatment, 80% were females; nearly 90% of the patients belonged to age group 15–45 years, and over 60% were below 30 years. Among those diagnosed for Trichomonas vaginalis, 14.6% had coexistent HIV infection. The compliance with respect to single dose treatment was significantly better than the long-duration oral regimen and has a significant relation with side effects of the treatment. The outcome is generally better and comparable and shows no significant difference between different treatment regimens used in the study. Metronidazole and tinidazole are commonly used drugs in various regimens. Compliance is better with those treated with tinidazole and metronidazole single dose than with other groups. Outcome is comparable between these regimens, especially when combined with other important factors like abstinence and treatment of the partners. The treatment regimens mainly differed in the compliance side effects profile and duration of therapy, which suggests that to improve the compliance of the drugs with fewer side effects, short course regimen would be a preferred choice.



2019 ◽  
Vol 9 (3) ◽  
pp. 80-83
Author(s):  
K. England ◽  
T. Masini ◽  
E. Fajardo

The World Health Organization (WHO) currently recommends Xpert® MTB/RIF as the initial test for all people with presumptive tuberculosis (TB). A number of challenges have been reported, however, in using this technology, particularly in low-resource settings. Here we examine these challenges, and provide our perspective of the barriers to Xpert scale-up as assessed through a survey in 16 TB burden countries in which the Médecins Sans Frontières is present. We observed that the key barriers to scale-up include a lack of policy adoption and implementation of WHO recommendations for the use of Xpert, resulting from high costs, poor sensitisation of clinical staff and a high turnover of trained laboratory staff; insufficient service and maintenance provision provided by the manufacturer; and inadequate resources for sustainability and expansion. Funding is a critical issue as countries begin to transition out of support from the Global Fund. While it is clear that there is still an urgent need for research into and development of a rapid, affordable point-of-care test for TB that is truly adapted for use in low-resource settings, countries in the meantime need to develop functional and sustainable Xpert networks in order to close the existing diagnostic gap.



2015 ◽  
Vol 2 ◽  
pp. 2333794X1558911
Author(s):  
Noah Kojima ◽  
Claire C. Bristow ◽  
Neil Pollock ◽  
Pierre Crouse ◽  
Harry Theodore ◽  
...  

Male circumcision is highly protective against urinary tract infections, inflammatory conditions of the penis, sexually transmitted infections, and urogenital cancers. We aimed to reintroduce newborn male circumcision through the creation of a training program in Port-au-Prince, Haiti—an area with a considerable burden of preventable urogenital infections, sexually transmitted infections, and low circumcision rate—after an earlier study reported that a majority of Haitian medical providers were in need of and wanted newborn circumcision training. The program was conducted at the GHESKIO Health Centers, a large, non-governmental clinic offering comprehensive pediatric and adult health services. Two Haitian obstetricians and seven nurses learned circumcision procedures. On training completion, one of two obstetricians achieved surgical competence. Introduction of a newborn male circumcision training program was feasible, achieving an acceptable rate of procedural competency and high-quality services. Permanent resources now exist in Haiti to train additional providers to perform newborn male circumcisions.



2021 ◽  
Vol 2 (6) ◽  
pp. 13-16
Author(s):  
Subhashchandra Daga

Backgorund: Hypothermia in babies may increase mortality, directly or indirectly, by potentiating the effect of the other morbidities. Guidelines published by The World health organization (WHO) on newborn health (2015) may be inadequate to address the issue in a low-resource setting. To be relevant in such a context, they should be user-friendly for the trainers of health workers (HW) who may be responsible for interpreting the recommendations and training the HW. Text: According to earlier guidelines (2013), ‘No randomized or quasi-randomized trial that evaluated the impact of keeping infants warm after discharge (hospital births) or after 24 hours (home births) was identified’. However, kangaroo mother care (KMC), a strong recommendation with moderate-quality evidence, and thermal protection are inseparable, as the most crucial component of KMC is skin-to-skin contact, which keeps a baby warm. A HW may be surprised when the guidelines or the basis change and, the move comes at a time when the earlier guidelines (1993) are just finding roots in patient care practices. Current guidelines are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, where randomized trials assume more importance. The guidelines recommend the following methods to keep infants warm after birth: KMC (strong recommendation, moderate-quality evidence), intermittent KMC (strong recommendation, moderate-quality evidence), and radiant warmers or incubators (strong recommendation, very low-quality evidence). The divergence between the evidence and the recommendations may be difficult for the HW to comprehend. Conclusions: The guidelines for postnatal care need to be revisited and revised so that clear and feasible options for keeping infants warm in low-resource settings are offered. Besides KMC, warm rooms, heated mattresses, plastic wraps and Styrofoam boxes may be suggested. What is already known about this subject? •       In the absence of a randomized or quasi-randomized trial that evaluated the impact of keeping infants warm, there are fewer options in a low-resource setting. •       They include Kangaroo mother care and incubators/radiant warmers. What does this study add? •       Options that may not have been supported by randomized trials but have consistent results may be suggested. •       They include warm rooms, heated mattresses, plastic wraps and Styrofoam boxes. •       In future revisions, the level of evidence should be paired with the recommendations. How might this impact on clinical practice or future developments? The health worker may choose the most feasible option at home or at a facility.



2020 ◽  
Author(s):  
Grace Esther Kushemererwa ◽  
Ismail Kayongo ◽  
Patrick Semanda ◽  
Hellen Nansumba ◽  
Iga Tadeo ◽  
...  

AbstractBackgroundGlobally response to the SARS-CoV-2 pandemic is highly limited by diagnostic methods. Currently, World Health Organization (WHO) recommends the use of molecular assays for confirmation of SARS-CoV-2 infection which are highly expensive and require specialized laboratory equipment. This is a limitation in mass testing and in low resource settings. SARS CoV-2 IgG/IgM antibody tests have had poor diagnostic performance that do not guarantee their use in diagnostics. In this study we demonstrate a concept of using a combination of RDTs in an algorithm to improve their performance for diagnostics.MethodEighty six (86) EDTA whole blood samples were collected from SARS-CoV-2 positive cases admitted at Masaka and Mbarara Regional Referral Hospitals in Uganda. These were categorized from day when confirmed positive as follows; category A (0-3 days, 10 samples), category B (4-7 days, 20 samples), Category C (8-17 days, 11 samples) and Category D (18-28 days, 20 samples). Plasma was prepared, transported to the testing laboratory and stored at −200C prior to testing. A total of 13 RDTS were tested following manufacturer’s instructions. Data was entered in Microsoft Excel exported to STATA for computation of sensitivity and specificity. We computed for all possible combinations of 2 of the 13 RDTS (13C2) that were evaluated in parallel algorithm.ResultsThe individual sensitives of the RDTs ranged between 74% and 18% and there was a general increasing trend across the categories with days since PCR confirmation. A total of 78 possible combinations of the RDTs to be used in parallel was computated. The combinations of the 2 RDTS improved the sensitivities to 90%.DiscussionWe demonstrate that use of RDTs in combinations can improve their overall sensitivity. This approach when used on a wider range of combination of RDTs may yield combinations that can give sensitivities that are of diagnostics relevance in mass testing and low resource setting.



2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Yasmeen Houso ◽  
Mohammad A. Farraj ◽  
As'ad Ramlawi ◽  
Tamer Essawi

Background. Trichomoniasis is a common sexually transmitted disease caused by Trichomonas vaginalis. It is a major health problem worldwide. The World Health Organization (WHO) has estimated that 180 million infections are acquired annually worldwide. Methodology. Vaginal swabs (1207) were cultured for T. vaginalis on Trichomonas Medium no. 2 (Oxoid) soon after specimen collection. The cultures were examined daily using a light microscope to detect the presence of T. vaginalis. Results. The prevalence of T. vaginalis was 13.6% (164/1207). The infection rate was the highest during pregnancy, 28.1%, and the lowest among women whose spouses use condoms, 8.6%. Conclusions. The culture method was used in this study to accurately determine the prevalence of this parasite in the West Bank, Palestine. The results of the study will eliminate ambiguities concerning trichomoniasis in this country and will contribute to better management and proper treatment.



2020 ◽  
Vol 31 (4) ◽  
pp. 303-311
Author(s):  
Fazana Dessai ◽  
Makandwe Nyirenda ◽  
Motshedisi Sebitloane ◽  
Nathlee Abbai

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.



2020 ◽  
Vol 5 (03) ◽  
pp. 282-284
Author(s):  
Deepinder K. Chhina ◽  
Jyoti Chaudhary

AbstractIn December 2019, an outbreak of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) was declared in Wuhan, city of China. Later on, the World Health Organization declared COVID-19 as a pandemic on March 11, 2020. The clinical course of the disease ranges from asymptomatic cases to fatal severe respiratory illness. Various laboratory tests are available for the diagnosis of disease. The gold standard test is real-time PCR (polymerase chain reaction), whereas antigen testing can be used as a point-of-care test. Antibody detection by ELISA (enzyme-linked immunosorbent assay) can be used for the surveillance of the immune response.



2013 ◽  
Vol 7 (10) ◽  
pp. 720-725 ◽  
Author(s):  
Hanna Guimarães ◽  
Rita Castro ◽  
Luís Távora Tavira ◽  
Filomena da L. Exposto

Introduction: This study aimed to estimate the prevalence of Neisseria gonorrhoeae and Chlamydia trachomatis infections and to assess the therapeutic management of vaginal/urethral discharge and dysuria in patients with human immunodeficiency virus in Luanda, Angola, taking into account World Health Organization recommendations for sexually transmitted infection syndromic management. Methodology: Socio-demographic and medical data were obtained from 436 individuals, and clinical examinations were performed in 104 women and 8 men. Vaginal/cervical and urethral specimens were collected from 112 individuals for observation of Trichomonas vaginalis, yeasts and bacterial vaginosis, while urine samples were obtained from 415 patients (221 symptomatic and 194 asymptomatic). Diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis was performed by polymerase chain reaction assay. Results: The prevalence of N. gonorrhoeae and C. trachomatis was 8.4% (35/415) and 7.9%, (33/415) respectively. Eight of the 35 N. gonorrhoeae positive cases were treated. All men and women (79) who presented a positive wet mount/Gram stain were etiologically treated according to microscopy results. In contrast, 53.3% of the female patients (16/30) and 33.3% (1/3) of the male patients who presented microscopy negative results were treated for urinary tract infection or by syndromic approach. Among non-examined patients, 15% of women (12/80) and 52.5% of men (21/40) were treated without an etiological result. Syndromic treatment was preferentially given to non-examined males (19/40–47.5%) over females (12/80–15%) (p<0.01). Conclusions: The prevalence of N. gonorrehaea and C. trachomatis found in this study was high. WHO-recommended syndromic management of vaginal/urethral discharge is not being consistently and correctly applied.



2020 ◽  
pp. 20-31
Author(s):  
Abdelrahman H. Abdelmoneim ◽  
Mujahed I. Mustafa ◽  
Raghda Hatim Abdalhaleem Adlan ◽  
Noun Eltayeb Ahmed Abdulgader ◽  
Hiba Awadelkareem Osman Fadl ◽  
...  

Background: The COVID-19 pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). At the time of writing, neither a cure nor a vaccine has been approved by the World health organization (WHO)  for this disease. Given the fact that the severe acute respiratory syndrome coronavirus  (SARS) and Middle East Respiratory Syndrome (MERS) viruses have a genetic sequencing similar to SARS-CoV-2, and since the use of convalescent plasma therapy (CP) has proved its efficacy in SARS and MERS virus infections, researchers are starting to focus more on it as a possible therapy for the COVID-19 disease. The main objective of this rapid review is to report and summarize the published evidence on the role of convalescent plasma therapy in the current COVID-19 pandemic. Method: The PICO method was used to establish the review question. Moreover, papers were gathered from PubMed and Google scholar, critically appraised for the best evidence. Piersons 5-component scheme was used to check the quality of the review papers. Results: After website screening: 10 papers in PubMed and 6 papers from Google scholars were retrieved. There were encouraging reports regarding the uses of CP in the previous viral outbreaks likes SARS and Ebola, yet there is still a doubt on the efficacy of this mode of therapy in the current COVID-19 pandemic. Conclusion: CP is a very promising treatment approach for COVID-19 patients; however, more clinical trials are required to validate the effectiveness of this therapy. Keywords: COVID-19, convalescent plasma therapy, SARS-CoV-2, therapy.



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