Diagnostic Test Kits Research Articles

The Prevalence of Hepatitis B and Human Immunodeficiency Virus Infection among Pregnant Women Attending Antenatal Clinics in Calabar, Nigeria

Background: Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) are viral infections that are transmitted through transfusion of unscreened blood products, needlestick injuries, and unprotected sex. This was a study to determine the prevalence of Hepatitis B and HIV infection among pregnant women accessing antenatal care. Materials and Methods: Two ml of venous blood was also collected into ethylenediaminetetraacetic acid bottles for hepatitis B surface antigen (HBsAg) and HIV test using a rapid diagnostic test kit following the standard algorithm of performing diagnosis. Results: Of the 250 participants examined for the presence of HBV and HIV among pregnant women attending the antenatal clinic in Calabar, 14 (5.6%) and 3 (1.2%) were positive for HBsAg and HIV. Participants aged 26–30 years had the highest prevalence of HBsAg 8 (7.0%) and participants aged 31–35 had the highest prevalence of HIV 1 (3.2%). The seroprevalence of HBsAg and HIV infection among pregnant women attending antenatal clinics by occupation shows that students had the highest infection rate of 3 (9%) and 2 (6%) for HBsAg and HIV. Of the 250 participants enrolled, the level of HIV and HBV awareness was 178 (71.2%) and 242 (96.8%), respectively. Conclusions: The study has revealed that the prevalence of HBV and HIV is on the increase among pregnant women, with a prevalence of 5.6% and 1.2%, respectively. General precautions need to be strictly adhered to in the hospital and particularly in blood transfusion and handling of sharps objects.

Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia.

PurposeRapid severe acute respiratory syndrome coronavirus 2 test kits are crucial for bridging diagnostic gaps in health facilities and community screening mainly in resource limited settings. However, there is no objective evidence on their diagnostic performance. Thus, the study aimed to evaluate comparative diagnostic performance of three selected SARS-CoV-2 IgG/IgM rapid test kits in Ethiopia.MethodsA cross-sectional study was conducted among 200 clients between May and July 2020 in Addis Ababa, Ethiopia. The performance of three SARS-CoV-2 rapid test kits EGENE, CTK BIOTECKs Onsite, and ACON Biotech were evaluated using blood specimens against RT-PCR on respiratory swabs. Sensitivity, specificity, and agreement with each other and to RT-PCR were computed using Vassarstats, MedCalc and SPSS version 23 statistical software.ResultsTest kits showed a heterogeneous comparative diagnostic performance in their sensitivity and specificity. The sensitivity was 61.18% (95% CI: 49.96–71.37%), 74.12% (95% CI: 63.28–82.74%) and 83.53% (95% CI: 73.57–90.38%) for kit A, B and C, respectively. Similarly, the specificity was 96.52% (90.81–98.88%), 94.78% (88.52–97.86%) and 94.78% (88.52–97.86%) for test kit A, B and C, respectively. The test kits have an agreement with RT-PCR with kappa value of 0.60 (0.48–0.83), 0.71 (0.65–0.93), and 0.80 (0.76–1.04) for A, B, and C, respectively. There was a significant difference on diagnostic performance among the three test kits and PCR with a p-value < 0.001 Cochran’s Q test.ConclusionThe diagnostic performance of the test kits was promising and recommended for COVID-19 diagnostics in combination with RT-PCR to detect more infected patients. It allows determining the seroprevalence of the virus and true extent of SARS-COV-2 community spread in resource limited settings. We underline countries to evaluate rapid diagnostic test kits before diagnostic use.

Validation, certification and registration of veterinary diagnostic test kits by the World Organisation for Animal Health Secretariat for Registration of Diagnostic Kits.

In the field of diagnostic test validation, World Organisation for Animal Health (OIE) Reference Laboratories (RLs) have a pivotal role and provide the international community with impartial advice and support in the selection, development and validation of diagnostic tests, which can be applied to the specialist diseases for which they are designated. National RLs provide an invaluable function in supporting the introduction, ongoing validation and application of validated diagnostic tests in line with international standards. Experienced staff with extensive knowledge of such systems and access to specialist facilities for conducting work are available to monitor changes or advancements in technology. They consider their relevance and value to evolving diagnostic test requirements. Reference Laboratories often have a broad mandate of activity linking research or development programmes and surveillance activities to benefit the continual assessment and, if necessary, improvement of diagnostic tools. Reference Laboratories maintain or have access to unique biological archives (known positive and negative sample populations) and produce international reference standards, both of which are vital in establishing the necessary and detailed validation of any diagnostic test. Reference Laboratories act either singularly or in collaborative partnerships with other RLs or science institutes, but also, when required, and with impartiality, with the commercial sector, to ensure new tests are validated according to OIE standards. They promote and apply formal programmes of quality assurance (including proficiency testing programmes) for newly validated tests, ensuring ongoing monitoring and compliance with standards, or as required set out any limitations or uncertainties. Reference Laboratories publish information on test validation in the scientific literature and on relevant websites, as well as disseminating information at workshops and international conferences. Furthermore, they can offer training in the processes and systems underpinning test validation.

Coronavirus disease 2019 and its vaccines: An update.

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by coronavirus. Most of the people infected with the COVID-19 virus will experience mild-to-moderate respiratory illness and recover without requiring special treatment. Older people and those with underlying medical problems are more likely to develop serious illness. In December 2019, a novel coronavirus designated as severe acute respiratory syndrome (SARS) coronavirus 2 emerged in the city of Wuhan, China, and caused an outbreak of unusual viral pneumonia. Being highly transmissible, this novel coronavirus disease, also known as COVID-19, has spread fast all over the world. It has overwhelmingly surpassed SARS and Middle East respiratory syndrome in terms of both the number of infected people and the epidemic areas. Currently, there is no definite treatment for COVID-19 although some drugs are under investigation. Infections caused by these viruses are an enormous global health threat. Hence, the government has established fast-tracking research to develop rapid diagnostic test kits and vaccines at low cost. This review highlights the vaccines available against COVID 19 worldwide and its implications.

Use of Trained Non-Medical Staff to Improve Access to HIV Testing Services in Africa: Implementation of the World Health Organization Opt-out Approach in Cameroon.

Background:The Joint United Nations Programme on HIV/AIDS (UNAIDS) in 2019 estimated that 450,000 to 50,000 people in Cameroon were living with HIV, yet only 79% knew their HIV status which is far from the 90% target for 2020. To address this situation, Cameroon adopted the “Opt-out” strategy of the World Health Organization (WHO) and use of trained non-medical cadre (psychosocial agents) to reach out to more people with HIV testing services (HTS). This describes the implementation and outcomes of this strategy by reviewing the activity of a typical day in the Yaoundé Central Hospital (YCH) in Cameroon.Methods:HTS were offered to hospitalized and ambulatory patients (including their companions) in different departments of the YCH. Following screening for recent HIV testing, those with unknown HIV status that gave consent or did not explicitly refuse testing (as per the “Opt-out Strategy”), were counseled and tested for HIV. Testing followed the “National HIV Rapid Testing Algorithm” using rapid diagnostic test kits. Results were either positive, negative or indeterminate. Patients with positive HIV results were linked to the Care and Treatment Center for treatment initiation.Results:Of the 350 patients screened and offered HTS using non-medical cadre (psychosocial agents), 193 (55.1%) were hospitalized and 157 (44.9%) came for outpatient visits. The age of participants ranged from 14 to 92 years and the yield of HIV testing in the sample population was 5.1% (6.2% for hospitalized patients and 3.8% for outpatient clinics). Statistics revealed that five HIV-positive patients had never been offered HTS before the study. The study revealed that HTS acceptance rate among hospitalized patients was 69.6% and that all new positive patients started antiretroviral treatment on the same day.Conclusion and Global Health Implications:It is feasible to use trained non-medical staff for HIV testing services (HTS). Task-shifting by using trained psychosocial agents can help in case identification and linkage to HIV treatment services.

458. Molecular SARS-CoV-2 Testing During the COVID-19 Outbreak: Experiences of a Hospital in Southeast Michigan, USA

BackgroundThe novel Coronavirus SARS CoV-2 (COVID-19) outbreak was complicated by the lack of diagnostic testing kits. In early March 2020, leadership at Beaumont Hospital, Royal Oak Michigan (Beaumont) identified the need to develop high capacity testing modalities with appropriate sensitivity and specificity and rapid turnaround time. We describe the molecular diagnostic testing experience since initial rollout on March 16, 2020 at Beaumont, and results of repeat testing during the peak of the COVID-19 pandemic in MI.MethodsBeaumont is an 1100 bed hospital in Southeast MI. In March, testing was initially performed with the EUA Luminex NxTAG CoV Extended Panel until March 28, 2020 when testing was converted to the EUA Cepheid Xpert Xpress SARS-CoV-2 for quicker turnaround times. Each assay was validated with a combination of patient samples and contrived specimens.ResultsDuring the initial week of testing there was > 20 % specimen positivity. As the prevalence grew the positivity rate reached 68% by the end of March (Figure 1). Many state and hospital initiatives were implemented during the outbreak, including social distancing and screening of asymptomatic patients to increase case-finding and prevent transmission. We also adopted a process for clinical review of symptomatic patients who initially tested negative for SARS-CoV-2 by a group of infectious disease physicians (Figure 2). This process was expanded to include other trained clinicians who were redeployed from other departments in the hospital. Repeat testing was performed to allow consideration of discontinuation of isolation precautions. During the surge of community cases from March 16 to April 30, 2020, we identified patients with negative PCR tests who subsequently had repeat testing based on clinical evaluation, with 7.1% (39/551) returning positive for SARS- CoV2. Of the patients who expired due to COVID-19 during this period, 4.3% (9/206) initially tested negative before ultimately testing positive.Figure 1 BH RO testing Epicurve Figure 2: Screening tool for repeat COVID19 testing and precautions ConclusionMany state and hospital initiatives helped us flatten the curve for COVID-19. Our hospital testing experience indicate that repeat testing may be warranted for those patients with clinical features suggestive of COVID-19. We will further analyze these cases and clinical features that prompted repeat testing.Disclosures All Authors: No reported disclosures

Rapid and Cost Effective Covid-19 Diagnostic Test Kit

Covid-19 or Corona virus disease spreading since December 2019, starting from Wuhan China has now become a pandemic throughout the globe. For early detection of the infected persons prior to the onset of the disease has become necessary to stop the spreading of this communicable disease. The process of testing of respiratory Covid-19 and the associated SARS- COV-2 virus is proved to be possible only by the detection of antibody produced due to response to the infection. This process of antibody detection can be used for both diagnosis and population surveillance. The testing of generated antibodies due to SARS-COV-2 are antibody isotopes that are to be detected are IgG and IgM. Due to having novel antigens, the first responding antigen antibody interactions was IgM. Antibodies that show a higher affinity for more specifically binding capable antigens leading to the proper immune response is IgG. Due to the infectious reactions, IgG antibodies are produced. The positiveness of a sample is considered if both IgG and IgM are present. Whole blood, serum or plasma specimens are used for membrane based immunoassay in a qualitative IgG and IgM test kit. The principle for the testing is the same that of a HCG pregnancy test where human glycoprotein is assayed in a rapid chromatographic way. The mentioned process is very useful for mass detection of the Covid-19 infected population in a minimum time and is also safe for the laboratory technicians as it can easily be done without getting infected if proper physical barrier is taken personally.

Performance Evaluation of SHOX2 and RASSF1A Methylation for the Aid in Diagnosis of Lung Cancer Based on the Analysis of FFPE Specimen.

Emerging molecular diagnostic methods are more sensitive and objective, which can overcome the intrinsic failings of morphological diagnosis. Here, a RT-PCR-based in vitro diagnostic test kit (LungMe®) was developed and characterized to simultaneously quantify the DNA methylation of SHOX2 and RASSF1A in FFPE tissue specimens. The clinical manifestations were evaluated in 251 FFPE samples with specificity and sensitivity of 90.4 and 89.8%, respectively. Furthermore, the quantitative analysis shows that the degree of SHOX2 methylation was correlated with the stages of lung cancer, but not in the case of RASSF1A. Our observation indicated that the DNA methylation of SHOX2 and RASSF1A may play different roles in cancer development. Comparison of the methylation levels of SHOX2 and RASSF1A between cancer and cancer-adjacent specimens (n = 30), showed they have “epigenetic field defect”. As additional clinical validation, the hypermethylation of SHOX2 and RASSF1A was detected not only in surgical operative specimens, but also in histopathological negative puncture biopsies. SHOX2 and RASSF1A methylation detection can be used to increase sensitivity and NPV, which provide us with a more accurate method of differential diagnosis and are likely to be rapidly applied in clinical examinations.

Post-market assessment of two rapid diagnostic test kits used in the diagnosis of HIV in the Wa municipality - Ghana, 2018

Post-market assessment of two rapid diagnostic test kits used in the diagnosis of HIV in the Wa municipality - Ghana, 2018

Characterization of putative drug resistant markers in Plasmodium falciparum isolated in Ghanaian blood donors

Background: Plasmodium falciparum parasites are commonly detected in blood donors in malaria-endemic areas. Even though few cases of transfusion-transmitted malaria have been reported, this study sought to establish the relative proportions of putative anti-malaria drug biomarkers in Ghanaian blood donors. Methods & Materials: Blood donors were randomly selected from five districts in Greater Accra region, Ghana. Each donor sample was screened with SD Bioline rapid diagnostic test kit (RDT). Dry blood spots were prepared from positive samples and shipped to Malaria Genome Laboratory, Wellcome Sanger Institute, Hinxton-UK for sequencing by genotyping of Pfcrt, Pfmdr1, Pfdhfr, Pfdhps and Kelch 13 genes. Results: A total of 771 blood donors were sampled out of which 91 (11.8%) were confirmed infected by RDT. Analysis of sequence reads indicated successful genotyping of Pfcrt, Pfmdr1, Pfdhfr, Pfdhps and Kelch 13 genes in 67 (73.6%), 64 (70.3%), 69 (75.8%), 69 (75.8%) and 84 (92.3%) of the genotyped isolates respectively. Of the total isolates, 191 different mutant haplotypes and single nucleotide polymorphisms were identified. In Pfcrt, CVIET haplotype was observed in 9 (13.4%) samples. In Pfmdr1, NFD, NYY, YFN and NFY haplotypes were identified in 4 (6.3%), 4 (6.3%), 6 (9.4%) and 8 (12.5%) samples respectively. In Pfdhfr gene single [NRSI, n = 17 (24.6%); NCNI, n = 20 (28.9%)], double [IRNI, n = 13 (18.8%); NRNI, n = 6 (8.6%)] and triple [IRNI, n = 6 (8.6%)] mutations were observed while in Pfdhps gene, the following haplotypes were seen: SGKAA (n = 19, 27.5%), AGKAA (n = 17, 24.6%), AGKAS (n = 13, 18.8%), AGKSA (n = 9, 13.0%), FGKAS (n = 5, 7.2%), AGKSS (n = 5, 7.2%) and AGESS (n = 1, 1.4%). Finally, in Kelch 13 gene, four non-synonymous mutations were identified in 11 isolates; P615L (n = 4, 4.8%), A578S (n = 4, 4.8%), I543 V (n = 2, 2.4%) and A676S (n = 1, 1.2%). Conclusion: The results obtained in this study indicated up to 28.9% risk of being transmitted with anti-malaria drug resistant gene during transfusion of P. falciparum infected blood. However, not higher than 12.5% putative drug resistant biomarkers could reduce efficacy of artemisinin combination therapy.

3D printing of nasopharyngeal swabs for COVID-19 diagnose: Past and current trends.

The current technological advancements in emerging 3D printing technologies are indeed propitious. To date, ground-breaking 3D printing technologies are used in automobile, aerospace, clothing, pharma, and biomedical industries by creating pre-requisite engineered and tailored end-user products reaching standard sets. 3D printing is also becoming a crucial technology in support of enhanced health care and general emergency response since the beginning of the COVID-19 pandemic. As the world is facing a significant lack of medicinal supplies, manufactures are struggling to fulfill demands due to the ongoing COVID-19 pandemic. The decline in the diagnostic testing kits supply chained to increased interest in 3D printed Nasopharyngeal (NP) swabs. This article has reviewed and studied the sensitivity of the NP swabs and various NP swab designs. The process of different 3D printing technologies that are employed to address the swab shortages during COVID-19 is explained in detail. The paper ends with the conclusions drawn from the literature review.

The availability, use and disposal of malaria and HIV rapid diagnostic test kits in health facilities in the greater Accra region of Ghana

Background: The Malaria and HIV rapid diagnostic tests (RDTs) are some of the commonest tests that are used in Ghana to support malaria and HIV management/care respectively. When these devices are used, they are categorized as potentially infectious. This paper aims to highlight the availability and management of used malaria and HIV RDTs in various healthcare facilities and by health service providers in the greater Accra region of Ghana.Methods: Data was obtained from 400 health facilities including hospitals, clinics, health centres, and pharmacies and over the counter medicine seller’s shops using purposive sampling technique with the aid of structured questionnaires and observation of practices.Results: Seventy percent of the facilities (n=280) used only malaria RDTs, 29% (n=116) used both malaria and HIV RDTs and 1% (n=4) reported using HIV RDTs only. 81.7% (n=326) which formed the majority used less than 10 RDTs daily. There was poor waste segregation, storage, transportation, treatment and disposal of waste. Facilities that had some sort of on-site treatment of waste used single chambered incinerators.Conclusions: Each of the categories of health facilities had a common practice of poor hazardous waste management. We therefore recommend that there should be enhancement of education and training of practitioners in the health facilities and the general public on the optimal use of the RDTs and disposal or the management of healthcare waste in general. The environmental protection agency and ministry of health should collaborate and enforce all the regulations on healthcare waste management in the various facilities.

Malaria and Typhoid Fever: Prevalence, Co-Infection and Socio-Demographic Determinants among Pregnant Women Attending Antenatal Care at a Primary Healthcare Facility in Central Nigeria

Aims: This study was conducted to evaluate the prevalence, co-infection and socio-demographic determinants of malaria and typhoid fever among pregnant women attending antenatal care at a primary health care facility in Central Nigeria.&#x0D; Study Design: The study was a cross sectional study.&#x0D; Place and Duration of Study: Keffi, Nasarawa State, between January and October, 2020.&#x0D; Methodology: Blood sample (4 ml) was collected from each of the 429 consenting pregnant women attending antenatal care at Primary Healthcare Centre main market, Keffi, Nasarawa State. Malaria parasite was detected from the blood samples using one-step malaria rapid diagnostic test kit (SD Bioline, Inc, USA) and was confirmed by Gimesa stained thin and thick film microscopy while typhoid fever was diagnosed using Cromatest widal commercial antigen suspension (Linear Chemicals, Barcelona, Spain). Data collected were analysed using Smith’s Statistical Package (version 2.8, California, USA) and P value of ≤ 0.05 was considered statistically significant.&#x0D; Results: Of the 429 pregnant women screened, 123(28.7%) had malaria, 33(7.7%) had typhoid fever while 12(2.8%) had malaria-typhoid co-infection. Malaria-typhoid co-infection was found to be higher among pregnant women aged ≤30 years (3.5%), traders (3.9%), with primary education (3.2%) and who were from rural areas (6.3%). However, only location of the pregnant women was associated with the rate of malaria-typhoid co-infection (P&lt; 0.05) whereas age, educational status and occupation were independent of the co-infection (P&gt; 0.05).&#x0D; Conclusion: We confirmed the presence of malaria-typhoid co-infection among pregnant women in the study area. Considering it adverse effects on pregnancy and it outcome, there is need for more efforts towards it prevention, control and management.

Steering the Private Sector in COVID-19 Diagnostic Test Kit Development in South Korea.

Responsive private sector engagement in developing test kits for coronavirus disease (COVID-19) in South Korea offers a valuable case study in public–private partnership and infectious disease governance. Korean biotech firms promptly developed diagnostic test kits, and the nation achieved capacity to test more than 20,000 people daily. This was a direct result of the continuous application of lessons learned from the Middle Eastern respiratory syndrome outbreak in 2015. South Korea had been strengthening the private sectors' infectious disease governance and response capacity, creating various new constructive pathways toward public–private partnership. Regulatory amendments were made to better liaise with the private sector. Government-led investment had increased in the research and development of testing technologies over the past 5 years. Furthermore, the Korean government had introduced fast-tracking approval, allowing open competition for more than 20 domestic biotech companies to develop test kits. An overview of test kit governance informs us of the importance of public–private partnership for pandemic threats.

Analysis of human coronaviruses circulation

The novel SARS-CoV-2 coronavirus, which emerged at the end of 2019 and caused a worldwidepandemic, triggered numerous questions about the epidemiology of the novel COVID-19 disease and about wellknown coronavirus infections, which used to be given little attention due to their mild symptoms. The routine screening-based multiyear retrospective observational study of prevalence andcirculation patterns of epidemic-prone human coronaviruses in Moscow. The real-time polymerase chain reaction was used to detect RNA of human coronaviruses(HCoVs) in nasal and throat swabs from 16,511 patients with an acute respiratory infection (ARI), aged 1 month to 95 years (children accounted for 58.3%) from January 2016 to March 2020, and swabs from 505 relatively healthy children in 2008, 2010 and 2011.Results. HCoVs were yearly found in 2.6-6.1% of the examined patients; the detection frequency was statisticallyhigher in adults than in children, regardless of sex. At the height of the disease incidence in December 2019,HCoVs were detected in 13.7% of the examined, demonstrating a two-fold increase as compared to the multi-yearaverage for that month. The statistical frequency of HCoV detection in ARI pediatric patients under 6 years wassignificantly higher than in their healthy peers (3.7 vs 0.7%, p = 0.008). HCoVs circulate annually, demonstrating a winter-spring seasonal activity pattern in the MoscowRegion and reaching peak levels in December. Over the years of observation, the HCoV epidemic activity reachedmaximum levels in December 2019-February 2020 and decreased in March to the multi-year average. Amida growing number of SARS-CoV-2 cases imported to Moscow in March 2020, the HCoV detection frequencydropped sharply, which can be explained by the competition between different coronaviruses and by the specificityof HCoV detection with the diagnostic test kit used in this study.

We Need to Talk About Rationing: The Need to Normalize Discussion About Healthcare Rationing in a Post COVID-19 Era.

The global COVID-19 pandemic has brought the issue of rationing finite healthcare resources to the fore. There has been much academic debate, media attention, and conversation in the homes of everyday individuals about the allocation of medical resources, diagnostic testing kits, ventilators, and personal protective equipment. Yet decisions to prioritize treatment for some individuals over others occur implicitly and explicitly in everyday practices. The pandemic has propelled the socially taboo and unavoidably prickly issue of healthcare rationing into the public spotlight—and as such, healthcare rationing demands ongoing public attention and transparent discussion. This article concludes that in the aftermath of COVID-19, policymakers should work towards normalizing rationing discussions by engaging in transparent and honest debate in the wider community and public domain. Further, injecting greater openness and objectivity into rationing decisions might go some way towards dismantling the societal taboo surrounding rationing in healthcare.

A prolonged cholera outbreak caused by drinking contaminated stream water, Kyangwali refugee settlement, Hoima District, Western Uganda: 2018

BackgroundOn 23 February 2018, the Uganda Ministry of Health (MOH) declared a cholera outbreak affecting more than 60 persons in Kyangwali Refugee Settlement, Hoima District, bordering the Democratic Republic of Congo (DRC). We investigated to determine the outbreak scope and risk factors for transmission, and recommend evidence-based control measures.MethodsWe defined a suspected case as sudden onset of watery diarrhoea in any person aged ≥ 2 years in Hoima District, 1 February–9 May 2018. A confirmed case was a suspected case with Vibrio cholerae cultured from a stool sample. We found cases by active community search and record reviews at Cholera Treatment Centres. We calculated case-fatality rates (CFR) and attack rates (AR) by sub-county and nationality. In a case-control study, we compared exposure factors among case- and control-households. We estimated the association between the exposures and outcome using Mantel-Haenszel method. We conducted an environmental assessment in the refugee settlement, including testing samples of stream water, tank water, and spring water for presence of fecal coliforms. We tested suspected cholera cases using cholera rapid diagnostic test (RDT) kits followed by culture for confirmation.ResultsWe identified 2122 case-patients and 44 deaths (CFR = 2.1%). Case-patients originating from Demographic Republic of Congo were the most affected (AR = 15/1000). The overall attack rate in Hoima District was 3.2/1000, with Kyangwali sub-county being the most affected (AR = 13/1000). The outbreak lasted 4 months, which was a multiple point-source. Environmental assessment showed that a stream separating two villages in Kyangwali Refugee Settlement was a site of open defecation for refugees. Among three water sources tested, only stream water was feacally-contaminated, yielding > 100 CFU/100 ml. Of 130 stool samples tested, 124 (95%) yielded V. cholerae by culture. Stream water was most strongly associated with illness (odds ratio [OR] = 14.2, 95% CI: 1.5–133), although tank water also appeared to be independently associated with illness (OR = 11.6, 95% CI: 1.4–94). Persons who drank tank and stream water had a 17-fold higher odds of illness compared with persons who drank from other sources (OR = 17.3, 95% CI: 2.2–137).ConclusionsOur investigation demonstrated that this was a prolonged cholera outbreak that affected four sub-counties and two divisions in Hoima District, and was associated with drinking of contaminated stream water. In addition, tank water also appears to be unsafe. We recommended boiling drinking water, increasing latrine coverage, and provision of safe water by the District and entire High Commission for refugees.

Flow Cytometric Analyses of Lymphocyte Markers in Immune Oncology: A Comprehensive Guidance for Validation Practice According to Laws and Standards.

Many anticancer therapies such as antibody-based therapies, cellular therapeutics (e.g., genetically modified cells, regulators of cytokine signaling, and signal transduction), and other biologically tailored interventions strongly influence the immune system and require tools for research, diagnosis, and monitoring. In flow cytometry, in vitro diagnostic (IVD) test kits that have been compiled and validated by the manufacturer are not available for all requirements. Laboratories are therefore usually dependent on modifying commercially available assays or, most often, developing them to meet clinical needs. However, both variants must then undergo full validation to fulfill the IVD regulatory requirements. Flow cytometric immunophenotyping is a multiparametric analysis of parameters, some of which have to be repeatedly adjusted; that must be considered when developing specific antibody panels. Careful adjustments of general rules are required to meet legal and regulatory requirements in the analysis of these assays. Here, we describe the relevant regulatory framework for flow cytometry-based assays and describe methods for the introduction of new antibody combinations into routine work including development of performance specifications, validation, and statistical methodology for design and analysis of the experiments. The aim is to increase reliability, efficiency, and auditability after the introduction of in-house-developed flow cytometry assays.

Hepatitis B virus infection, knowledge and vaccine uptake among hairdressers in Ikorodu, Lagos State

Abstract Background Hepatitis B is a major public health concern. Hepatitis B virus (HBV) continues to thrive in developing countries including Nigeria. Occupationally exposed persons like people working in women's beauty salon are at high risk of HBV infection and may play a critical role in the disease transmission via contaminated needles and sharps. The aim of this study therefore was to estimate HBV infection, knowledge level, occupational risk perception and vaccine uptake among people working in women's beauty salons. Also to get them screened and encourage those that are negative to get vaccinated to curb the spread of this infection. Methods This was a cross-sectional study carried out on 199 people working in women's beauty salons in Ikorodu Local government area of Lagos State. HBsAg screening using a rapid diagnostic test kit was carried out for all respondents to determine their infection status. Questionnaire which assessed their knowledge level and occupational risk perception were completed by trained interviewers and data was analysed using SPSS software. Results The result of this study showed that only 2.01% respondents tested positive for the HBsAg screening. Majority of the respondents (69.3%) have poor knowledge about HBV transmission, prevention and vaccine. While most (78.9%) of the respondents don't know their occupational risk of exposure to HBV, 9.0% rated themselves at high risk of occupational exposure. Significant association was observed between level of knowledge and risk perception (P &amp;lt; 0.001). The level of vaccine uptake was very poor as only 1 out of 199 respondents has taken 3 doses of HBV vaccine, 60.9%(120) have not been vaccinated. Conclusions The respondents exhibited poor level of knowledge about HBV transmission, prevention, vaccination and went about their occupation without adequate protection form HBV. Key messages Screening of people working in women beauty salon is highly imperative to identify those with infection so that they can be treated on time while those that are negative should be vaccinated. Due to the potential roles of people working in women’s beauty salon in HBV transmission, education programs and vaccine coverage policy should be adopted for people in this occupation.

Coronavirus-19 and malaria: The great mimics.

The use of SARS-CoV-2 rapid diagnostic test (RDT) kits by some African countries for screening has raised serious concerns over their role in malaria areas. Coupled with a lack of adequate personal protective equipment and the scarcity of knowledge on the possible interaction between malaria and COVID-19 both in terms of presentations and shared symptoms, this has left many frontline health workers with fears and anxieties. Several anecdotal reports have already raised questions pertaining to possible false-positive COVID-19 results in proven malaria cases by use of SARS-CoV-2 RDT kits with huge costs to already constrained budgets. The report raises concerns on the use of SARS-CoV-2 kits in malaria areas in terms of cost, to prompt research, allay fears and guide policy during this pandemic and beyond.