Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial.

BACKGROUND: Most women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling. METHOD: This two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard. RESULTS: 22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative. CONCLUSION: VIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone. TRIAL REGISTRATION NUMBER: NCT05125380.

Concordance of Anyplex™ II HPV HR assays with reference HPV assays in cervical cancer screening: Systematic review.

INTRODUCTION: Genital infection with certain types of human papillomaviruses (HPVs) is a major cause of premalignant dysplasia and cervical cancer globally. Identification of 14 high-risk human papillomaviruses (HR-HPV) is immensely important in elucidating molecular epidemiology, patient monitoring, and evidence-based treatment. HPVs testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. Thus, HPV assays are increasingly used for primary cervical screening and HPV genotyping, for monitoring vaccination-effect and determining changes in the epidemiology of viral genotypes across the globe. Testing for high-risk HPV is more effective in primary cervical cancer screening than in the cytological examination of a Pap smear. Separate genotyping may be useful for triage in both HPV-based and cytology-based screening. It should be used only for clinically validated tests. AIMS: To evaluate the concordance of Anyplex™ II HPV HR with other HPV assays in cervical cancer screening. METHODS: Validation studies of Anyplex™ II HPV HR assay from PubMed, google scholar, google database and Scopus were used to search articles. Articles published in English from 2013 onwards were systematically searched using keywords. Besides, other databases like Google Scholar and the Google database were searched manually for grey literature. The last search was done in December 2020. Then study eligibility, extracted data, and assessed risk of bias were assessed. Due to the great clinical heterogeneity of the included articles, the diagnostic performance of the anyplex II ™ HR HPV test was unlikely to be pooled. Rather, I did a descriptive presentation of the test performance to gather the best synthesis of evidence for the anyplex II ™ HR HPV test for the detection of CIN2+. Studies that evaluate the performance of the assay in terms of its sensitivity, specificity, reproducibility and positive and negative predictive values to comparator assays and/or histology were included in this review. RESULTS: Anyplex™ Ⅱ HPV HR showed consistently high absolute clinical sensitivity for CIN2+ and CIN3+, as well as comparative clinical sensitivity relative to the currently most widely used HPV test. Because of the significantly diff ;erent composition of the referral populations, Anyplex™ Ⅱ HPV HR absolute clinical specificity for CIN2+ and CIN3+ varied across studies but was comparable relative to reference assays. CONCLUSION: Five validation studies of Anyplex™ Ⅱ HPV HR performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, still comparative clinical sensitivity and specificity relative to HC2 and GP5+/6 + PCR. Anyplex™ Ⅱ has evaluated HPV HR in several settings and population groups. It is considered clinically validated for primary cervical cancer screening and triage in referral population settings.

Comparison of the Diagnostic Performance of a Rapid Antigen Test with Real-Time Polymerase Chain Reaction for Detection of SARS-CoV-2 Among Patients Diagnosed with COVID-19 at Selected Hospitals in Addis Ababa, Ethiopia.

Background: When faced with a public health problem such as the COVID-19 pandemic, devising a test with an accurate and rapid diagnostic capacity is critical to contain the disease. We compared the diagnostic performance of a rapid antigen test in comparison with a reference method, namely a real-time polymerase chain reaction (RT-PCR) assay. Methods: We enrolled patients with confirmed COVID-19 from two selected hospital in Addis Ababa, Ethiopia, between January and November 2021. We assessed the performance of the Standard Q COVID-19 Ag Kit (SD Biosensor, Republic of Korea) in 200 nasopharyngeal and nasal swab samples. Results: Out of the 200 samples utilized for the diagnostic performance evaluation, equal proportion of the samples were confirmed positive and negative for SARS-CoV-2 based on RT-PCR. Of the 100 confirmed positive cases, 95 showed positive results with the rapid antigen test, yielding a sensitivity of 95% (95% confidence interval [CI] 88.7-98.4%). Of the 100 confirmed negative cases, there were three false-positive results, yielding a specificity of 97% (95% CI 91.5-99.4%). The sensitivity of the rapid antigen test was higher for samples with an RT-PCR cycle threshold (Ct) value ≤25 compared with samples with a higher Ct value. Conclusion: The finding demonstrated that the detection capacity of the Standard Q COVID-19 Ag Test meets the requirements set by the Ministry of Health Ethiopia. The high sensitivity and specificity of the test device indicate the possibility of using it for diagnostic and clinical purposes in resource-constrained settings such as Ethiopia.

Bacterial uropathogens and burden of antimicrobial resistance pattern in urine specimens referred to Ethiopian Public Health Institute.

BACKGROUND: Urinary tract infections (UTIs) are the leading causes of morbidity in the general population, and is the second most common infectious disease after respiratory infections. Appropriate antibiotic therapy is essential to achieving good therapeutic results. Therefore, the purpose of this study was to investigate the profile of pathogens cultured from urinary tract infections and to determine their resistance profiles to commonly prescribed antibiotics. METHOD: A cross-sectional study was carried out at the National Referral Laboratory of the Ethiopian Institute of Public Health from January 2017 to December 2018. All positive cultures were characterized by colony morphology, Gram stain, and standard biochemical tests. The antimicrobial susceptibility test of the isolate was performed using the Kirby- Bauer disk diffusion test on Muller-Hinton agar. In addition, bacterial identification, antimicrobial susceptibility testing and phenotypic detection of MDR were performed with VITEK 2 Compact according to the manufacturer's instructions. RESULT: Out of 1012 cultured urine specimens, 325 (32.1%) was showed significant bacteriuria. The overall prevalence of UTIs was 325(32.1%) and the highest prevalence rate was obtained from 21-30 years age group 73(22.5%). Among UTIs patients, 583(57.6%) were females and 429(42.4%) were males. The UTIs of 179 (55%) women is relatively higher than that of men 146 (45%). Among 325 isolates, Gram-negative bacteria (GNB) appeared more frequently 252 (51.7%) than Gram-positive bacteria 63 (19.4%). In GNB, E. coli 168(66.7%), Klebsiella species 32(12.7%), and Enterobacter species 13 (5.2%) were dominated isolates whereas in GPB accounted for coagulase-negative staphylococcus (CoNS) 33(52.4%), Enterococcus species 16(25.4%), and Staphylococcus aureus 10(15.9%). Major of the isolates showed high levels of antibiotic resistance to commonly prescribed antimicrobials. Imipenem, Amikacin, and Nitrofurantoin were the most sensitive antibiotics for Gram-negative isolates while Nitrofurantoin, clindamycin, and Gentamycin were effective against gram-positive uropathogens. Overall, 156/256(60.9%), 56/256(22.4%), 10/256(4%) of gram-negative isolates were MDR, XDR, and PDR respectively while among the GPB isolates, 34/63(53.1%), 10/63(15.8%), and 1/63(1.6%) were MDR, XDR, and PDR isolates respectively. Among the tested bacterial strains, 190/319 (59.5%) were MDR, 66/319 (20.7%) strains were XDR, and 11/319 (3.45%) were PDR isolated. CONCLUSION: The prevalence of urinary tract infection was high, and Gram-negative organisms were the most common causes of UTIs in this study. It was found that the resistance to commonly used antibiotics is very high. Early detection and close monitoring of MDR, XDR, or even PDR bacterial strains must be started by all clinical microbiology laboratories to reduce the menace of antimicrobial resistance that is now a global problem.

Urinary tract infection in cancer patients and antimicrobial susceptibility of isolates in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.

BACKGROUND: Urinary tract infections are the most common causes of morbidity and mortality in patients with cancer. The emergence of multiple-drug-resistant (MDR) strains of gram-negative bacteria causing urinary tract infection has become a serious concern in cancer patients. Therefore, the present study aimed to determine the spectrum and antibiotic resistance pattern of bacterial isolates related to urinary tract infections among cancer patients at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia. METHODS AND MATERIALS: Hospital based prospective cross-sectional study was conducted for three months from January to March 2018 in tertiary care hospital located in the capital city of the country. Gram-negative bacteria isolated from urine specimens from hospitalized patients with cancer were characterized using standard microbiological methods. Modified Kirby-Bauer disk diffusion technique was applied for antimicrobial susceptibility testing in accordance with CLSI 2019 criteria. RESULTS: Of totally 292 urine samples tested, eighteen (6.3%) were culture positive cases, Escherichia coli (44.4%) was the highest proportion isolated uropathogen followed by Klebsiella pneumoniae (22.2%) and Citrobacter diversus (16.7%). The antibiotic susceptibility results showed meropenem and nitrofurantoin as the most effective antibiotics for E. coli, K. pneumoniae, and Citrobacter diversus isolates. The rate of multidrug resistant (MDR) isolates were 33.3% (6/18), and meropenem and nitrofurantoin were the most effective antibiotic against MDR isolates. CONCLUSION: The study findings showed a significant distribution of MDR gram-negative bacteria which may increase the burden of urinary tract associated infections in cancer patients. Carbapenem (meropenem) can be considered as effective agents to treat MDR cases in our region.

Bacterial Profile among Patients with Suspected Bloodstream Infections in Ethiopia: A Systematic Review and Meta-Analysis.

INTRODUCTION: The burden of bloodstream infections (BSIs) has been warranted in Ethiopia. Globally, the emergency and raised resistance rate of bacterial antimicrobial resistance is becoming a prominent problem, and it is difficult to treat patients having sepsis. In this review, we aimed to determine the pooled prevalence of bacterial isolates among presumptive patients with bloodstream infections in Ethiopia. METHODS: A systematic search was performed from PubMed/MEDLINE, Scopus, HINARI, ScienceDirect, and Google Scholar electronic databases using PRISMA guidelines. The data analysis was carried out using STATATM version 14 after the records were cleaned and sorted out. RESULTS: A total of 26 studies with 8,958 blood specimens and 2,382 culture-positive bacterial isolates were included for systematic review and meta-analysis. The meta-analysis derived a pooled culture-positive bacterial prevalence which was 25.78% (95% CI: 21.55-30.01%). The estimated pooled prevalence of Gram-positive and Gram-negative bacterial isolates was 15.50% (95% CI: 12.84-18.15%) and 10.48 % (95% CI: 8.32-12.63%), respectively. The two common Gram-positive bacteria isolated from patients suspected of BSIs were coagulase-negative Staphylococcus with a pooled prevalence of 5.75% (95% CI: 4.58-6.92%) and S. aureus 7.04 % (95% CI: 5.37-8.72%). Similarly, the common Gram-negative bacterial isolates and their estimated pooled prevalence were E. coli 1.69% (95% CI: 1.21-2.16%), Klebsiella species 7.04 % (95% CI: 5.37-8.72%), Pseudomonas species 0.39% (95% CI: 0.08-0.70%), Salmonella species 1.09% (95% CI: 0.79-1.38%), and Streptococcus pyogenes 0.88% (95% CI: 0.54-1.22%). CONCLUSION: The prevalence of bacterial isolates among presumptive patients suspected to BSIs in Ethiopia remains high. Furthermore, we found a remarkable variation in the pathogen distribution across the study setting.