Rapid Diagnostic Test Kits Research Articles

Quality of Malaria and HIV Rapid Diagnostic Test kits (RDTs) in health facilities and medicines outlets in the Greater Accra Region of Ghana

Background: Questions remain on the quality of malaria and HIV Rapid Diagnostic Test kits (RDTs) stocked and used in health facilities in Ghana. The Food and Drugs Authority (FDA) in Ghana is mandated to regulate RDTs for quality. By this, all RDTs must be registered, and each brand given a unique registration number. This study aimed to assess the quality of malaria and HIV RDTs in health facilities in the Greater Accra Region of Ghana, using FDA standards. Method: Data was obtained using structured questionnaire from 400 facilities in three districts in the Greater Accra region. A multi-stage sampling procedure was used to select the health facilities including retail medicine outlets. Information on the registration status of the RDTs and conditions under which they were stored were gathered. RDTs kept in air conditioned or well-ventilated rooms were considered as being stored under good condition. RDTs, registered by the FDA and appropriately stored were considered to be of good quality. Data was coded, stored, and analyzed using STATA version 15. Results: About 17% of the malaria RDTs stocked in the pharmacies were unregistered, 85.7% in hospitals were registered. Also, 83.3% of HIV RDTs in the Policlinics were registered. Registration status of the RDTs were associated with the districts in which the health facilities were located (p = 0.006). The RDTs were generally stored under good conditions (99.5%). Over forty percent (41.9%) of user practitioners interviewed rated the quality of the malaria RDTs as good and 59.2% rated HIV RDTs as very good. Conclusion: Though there were some unregistered RDTs whose quality cannot be ascertained, the quality of malaria and HIV RDTs in the facilities assessed were rated as good and likely to produce good results for malaria and HIV case detection.

Reliability of Rapid Diagnostic Tests in the Diagnosis of Malaria amongst Children attending the Outpatient Department of the Tetteh Quarshie Memorial Hospital in the Akuapem North District of the Eastern Region of Ghana

Treatment of malaria, with the appropriate diagnostic tool, helps to reduce morbidity and mortality in children. The absence of resources and inadequate labor in emerging countries like Ghana make malaria microscopy difficult. The Rapid Diagnostic Test kit (RDT) remains unpopular despite its availability and ease of use because of limited research on its effectiveness leading to over­ prescription of antimalarial drugs. This study shows how reliable the malaria diagnostic test is. Out of 132 children were recruited in all into the study with more females (59.1%) than males (40.9%). 35 (26.5%) of children who were recruited tested positive for Plasmodium falciparum with the Malaria rapid diagnostic test cassette while 97 (73.5%) children tested negative for Plasmodium falciparum with the malaria diagnostic test cassette. In Malaria Microscopy, 35 (26.5%) children tested positive while 97 (73.5%) tested negative for malaria parasites. Out of the 35 children who tested positive, RDT picked 33 as positive and 2 as negative (sensitivity = 94.3%). While out of the 97 that tested negative for microscopy, RDT picked 94 as negative and 3 as positive (specificity= 96.9%). The positive predictive value and negative predictive values are 91.7% and 97.9%, respectively.This clearly shows the Rapid Diagnostic Test (RDT) is an effective diagnostic tool for the testing of malaria in children in the Akuapem North District in the Eastern Region of Ghana.

Field Evaluation of Diagnostic Performance and Factors Affecting Malaria Rapid Diagnostic Test in Seme, Kisumu County, Kenya

Quality diagnosis is important for effective management and control of malaria. The study assessed the factors affecting the performance of malaria rapid diagnostic test kits (mRDTs) in Seme Sub County, Kisumu. The study targeted three health facilities which were purposively sampled and convenience sampling was used to select the health care workers interviewed. The RDTs were randomly sampled. Descriptive statistics were summarized using tables and charts. The study revealed that RDTs storage, stock outs, staffs training, quality assurance, lack of bench job aids and standard operating procedures are factors affecting the performance of mRDTs. In conclusion, several factors affects the performance of mRDTs. The study recommends environmental monitoring of mRDTs during transportation, storage and testing process. The study also recommends regularly training of the health care workers on mRDTs and biannual proficiency testing for all mRDTs end users.

Seroprevalence and Risk Factors of Toxoplasma gondii Infection among Pregnant Women in Kumasi: A Cross-Sectional Study at a District-Level Hospital, Ghana.

Background This study investigated the prevalence and risk factors of Toxoplasma gondii infection among pregnant women in a district-level hospital in Ghana and compared the diagnostic performance of the rapid diagnostic test (RDT) and enzyme-linked immunosorbent assay (ELISA) for T. gondii diagnosis. Method This cross-sectional study included 400 consecutive consenting women in their first-trimester stage of pregnancy. A validated well-structured closed-ended questionnaire was used to collect sociodemographic data and possible risk factors of each participant. Blood samples were collected for analysis of T. gondii IgG and IgM using the commercial ELISA Kit and RDT. Results Seroprevalence of toxoplasmosis was 21.5% and 57.3% based on the RDT and ELISA technique, respectively. Secondary education (cOR = 1.9, 95% CI (1.1-3.1), and p = 0.020) and contact with cats (cOR = 1.7, 95% CI (1.1-2.8), and p = 0.030) were significant predictors of T. gondii infection, with the former being the only independent risk factor for T. gondii infection (aOR = 1.8, 95% CI (1.0-3.0), and p = 0.034) by the ELISA method. The sensitivity, specificity, and area under the curve (AUC) of RDT-IgM against ELISA were 42.9%, 95.9%, and 0.694, respectively, whereas those of RDT-IgG were 31.0%, 91.2%, and 0.611, respectively. The diagnostic consistency between the two methods was fair for both RDT-IgM (κ = 0.304) and RDT-IgG (κ = 0.201). Conclusion The prevalence of T. gondii infection among pregnant women at Kumasi is 21.5% and 57.3% based on the RDT and ELISA technique, respectively. Secondary education and contact with cats were the major risk factors of T. gondii infection. Using ELISA as the reference, the RDT used in this study for the diagnosis of T. gondii infection has low sensitivity, and therefore, it is unreliable. However, this finding does not invalidate all RDTs because there are several other brands of RDT with good sensitivity and specificity. Further studies to ascertain the performance of other commercially available RDT kits are needed.

SARS-CoV-2 Infection among the Dental Staff from Lombardy Region, Italy.

Dentists have been supposed to be among the healthcare workers at greatest risk of SARS-CoV-2 infection. However, scant data are available on the issue. The aim of this study is to quantify the SARS-CoV-2 antibody prevalence and determinants in a sample of dentists, dental hygienists, and other personnel employed among the dental staff in Lombardy region. We used an accurate rapid diagnostic test kit detecting immunoglobulins (Ig) in 504 adults. Of the 499 participants who obtained a valid antibody test, 54 (10.8%) had a SARS-CoV-2 positive test (0.4% IgM+, 1.8% both IgM+ and IgG+, and 8.6% IgG+). A statistically significant association with infection was found for geographic area (compared to Milan, adjusted odds ratio was 2.79, 95% confidence interval, CI: 1.01–7.68 for eastern and 2.82, 95% CI: 1.34–5.94, for southern Lombardy). The clinical staff did not result positive to SARS-CoV-2 more frequently than the administrative staff. This is the first study using antibody test in the dental staff personnel. It shows that the prevalence of SARS-CoV-2 infection in Lombardy region was around 10%, in line with estimates on other healthcare professionals. Despite the close physical contact with the patient, dentists have been able to scrupulously manage and effectively use protective devices.

SARS-CoV-2 Serological testing in frontline health workers in Zimbabwe.

BackgroundIn order to protect health workers from SARS-CoV-2, there is need to characterise the different types of patient facing health workers. Our first aim was to determine both the infection status and seroprevalence of SARS-CoV-2 in health workers. Our second aim was to evaluate the occupational and demographic predictors of seropositivity to inform the country’s infection prevention and control (IPC) strategy.Methods and principal findingsWe invited 713 staff members at 24 out of 35 health facilities in the City of Bulawayo in Zimbabwe. Compliance to testing was defined as the willingness to uptake COVID-19 testing by answering a questionnaire and providing samples for both antibody testing and PCR testing. SARS-COV-2 antibodies were detected using a rapid diagnostic test kit and SAR-COV-2 infection was determined by real-time (RT)-PCR. Of the 713 participants, 635(89%) consented to answering the questionnaire and providing blood sample for antibody testing while 560 (78.5%) agreed to provide nasopharyngeal swabs for the PCR SARS-CoV-2 testing. Of the 635 people (aged 18–73) providing a blood sample 39.1% reported a history of past COVID-19 symptoms while 14.2% reported having current symptoms of COVID-19. The most-prevalent co-morbidity among this group was hypertension (22.0%) followed by asthma (7.0%) and diabetes (6.0%). The SARS-CoV-2 sero-prevalence was 8.9%. Of the 560 participants tested for SARS-CoV-2 infection, 2 participants (0.36%) were positive for SAR-CoV-2 infection by PCR testing. None of the SARS-CoV-2 antibody positive people were positive for SAR-CoV-2 infection by PCR testing.Conclusion and interpretationIn addition to clinical staff, several patient-facing health workers were characterised within Zimbabwe’s health system and the seroprevalence data indicated that previous exposure to SAR-CoV-2 had occurred across the full spectrum of patient-facing staff with nurses and nurse aides having the highest seroprevalence. Our results highlight the need for including the various health workers in IPC strategies in health centres to ensure effective biosecurity and biosafety.

Malaria in Eswatini, 2012\u20132019: a case study of the elimination effort

Eswatini was the first country in sub-Saharan Africa to pass a National Malaria Elimination Policy in 2011, and later set a target for elimination by the year 2020. This case study aimed to review the malaria surveillance data of Eswatini collected over 8 years between 2012 and 2019 to evaluate the country’s efforts that targeted malaria elimination by 2020. Coverage of indoor residual spraying (IRS) for vector control and data on malaria cases were provided by the National Malaria Programme (NMP) of Eswatini. The data included all cases treated for malaria in all health facilities. The data was analysed descriptively. Over the 8 years, a total of 5511 patients reported to the health facilities with malaria symptoms. The case investigation rate through the routine surveillance system increased from 50% in 2012 to 84% in 2019. Incidence per 1000 population at risk fluctuated over the years, but in general increased from 0.70 in 2012 to 1.65 in 2019, with the highest incidence of 3.19 reported in 2017. IRS data showed inconsistency in spraying over the 8 years. Most of the cases were diagnosed by rapid diagnostic test (RDT) kits in government (87.6%), mission (89.1%), private (87%) and company/industry-owned facilities (84.3%), either singly or in combination with microscopy. Eswatini has fallen short of achieving malaria elimination by 2020. Malaria cases are still consistently reported, albeit at low rates, with occasional localized outbreaks. To achieve elimination, it is critical to optimize timely and well-targeted IRS and to consider rational expansion of tools for an integrated malaria control approach in Eswatini by including tools such as larval source management, long-lasting insecticidal nets (LLINs), screening of mosquito house entry points, and chemoprophylaxis. The establishment of rigorous routine entomological surveillance should also be prioritized to determine the local malaria vectors’ ecology, potential species diversity, the role of secondary vectors and insecticide resistance.

Foldscope: Diagnostic Accuracy and Feasibility of its Use in National Malaria Control Program.

Malaria has been an important public health all over the globe. Although conventional light microscopy is the gold standard of diagnosis, light microscopes are heavy, fragile, costly, and electricity dependent. Rapid diagnostic tests (RDTs) have become more popular but perform badly in temperate climate. This is because the RDT kits require maintenance of cold chain for its optimal use. In this regard, there is a recent interest in handheld malaria microscopy at the point of care in the field setting. Foldscopes are cheap, handy, nonfragile, and use mobile camera for illumination. The purpose of the study was to find whether foldscope can be used in the national vector borne disease control program (NVBDCP) in India. Ten laboratory technicians were trained in identifying malaria parasites using foldscope and their mobiles. Later, they were provided with unassembled foldscope to document their test results for the preidentified malaria slides. The blood smears were stained as per the protocol of NVBDCP. The report of the index test (foldscope microscopy) was compared with the reference test (conventional microscopy). The sensitivity and specificity of the index test was found to be 13.3% (6.257-26.18), specificity of 97.78% (88.43-99.61), positive predictive value 85.71% (48.69-97.43), and negative predictive value 53.01% (42.38-63.38). The devise failure rate and test failure rate were 20% and 11.7%. The kappa agreement between the index and reference microscopy was only 11% and the McNemar P < 0.01. The ×400 foldscope at its present magnification and illumination cannot be utilized in the field under NVBDCP.

Diagnostic performance of an ultrasensitive HRP2-based malaria rapid diagnostic test kit used in surveys of afebrile people living in Southern Ghana

BackgroundThe Alere™ Malaria Ag P.f Ultra-sensitive RDT (UsmRDT) kit is an HRP2-based malaria rapid diagnostic test (RDT) with enhanced sensitivity relative to the SD Bioline Malaria Ag P.f RDT (mRDT) kit. However, the diagnostic performance of the UsmRDT kit has not been evaluated in Ghana.MethodsA total of 740 afebrile participants aged between 3 and 88 years old were recruited from the Central and Greater Accra Regions of Ghana during the off-peak malaria season. Axillary body temperature was measured, and a volume of 1 ml venous blood was drawn from each participant. Prior to separating the blood into plasma and packed cell pellets via centrifugation, the blood was spotted onto one UsmRDT and one mRDT kit and also used to prepare thick and thin blood smears as well as filter paper blood spots. Plasmodium falciparum specific polymerase chain reaction (PCR) was performed on gDNA extracted from 100 µl of the whole blood.ResultsThe overall positivity rate for microscopy, PCR, UsmRDT and mRDT kit were 20.4%, 40.8%, 31.3% and 30.8%, respectively. Overall, the UsmRDT identified 9.3% (28/302) more PCR positive samples than the mRDT kits. All samples that were negative by the UsmRDT kit were also negative by the mRDT kit. Overall, the sensitivity and specificity of the UsmRDT was 73% (221/302) and 89% (388/436), respectively, while that for the mRDT kit was 58% and 90%, respectively.ConclusionAlthough the UsmRDT kit was not as sensitive as PCR at detecting asymptomatic P. falciparum carriage, it correctly identified P. falciparum in 9.3% of the study participants that were not captured by the mRDT kit. In malaria endemic settings, the UsmRDT would provide an added advantage by identifying more asymptomatic P. falciparum carriers than the mRDT kit for targeted treatment interventions.

Needs assessment of community health workers to enhance efficient delivery of their services for community case management of malaria in Kenya

BackgroundMalaria continues to be the leading cause of morbidity and mortality in Africa. Community Case Management of malaria (CCMm) which is undertaken by engaging Community Health Workers (CHWs) to effectively address management of malaria cases in some endemic communities was explored in this study. The aim was to assess the needs of CHWs that would help sustain and retain their services to enhance the efficient delivery of CCMm.MethodsUsing semi-structured questionnaires, data on the needs of CHWs was gathered through a qualitative study consisting of in-depth interviews and focus group discussions (FGDs) conducted among study participants in five districts in western Kenya. The study participants comprised of 100 CHWs, 100 mothers of children under five years and 25 key informants made up of public health officers and clinicians involved in the CCMm. The interviews were conducted in English and Swahili or Dholuo, the local language. The recorded audio interviews were transcribed later. The analysis was done using NVivo version 7 software and transcripts were coded after which themes related to the objectives of the study were identified.ResultsAll the study participants recognized the need to train and update CHWs on their work as well as remunerating them for their services to enhance efficient delivery of services. The CHWs on their part perceived the provision of gloves, rapid diagnostic test kits (RDTs), lancets, cotton wool and ethanol, bins (to dispose of RDTs and lancets), together with drugs for treating clients as the essential needs to undertake CCMm in the communities. Other logistical needs and incentives mentioned by CHWs and key informants for the successful delivery of CCMm included: gumboots, raincoats, torch lights, mobile phones, means of transportation (bicycles and motorbikes), uniforms and ID cards for identification.ConclusionsCHWs would perform tasks better and their services retained for a sustainable CCMm if: properly incentivized; offered refresher trainings (and updates) on malaria; and equipped with the requisite tools identified in this study.

Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China.

Rapid diagnostic tests as an attractive alternative to enzyme immunoassay could identify hepatitis C virus (HCV) infected persons more expeditiously. The availability of high performing and quality-assured rapid diagnostic tests are essential to scale-up HCV screening. The study was undertaken to evaluate the performance of seven domestic HCV rapid diagnostic tests kits. The kits were evaluated by using HCV serum panels, including HCV basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, seroconversion panel, and genotype qualification panel. The results showed that clinical sensitivity, clinical specificity and analytical specificity of seven rapid diagnostic tests kits ranged from 94% (95% CI: 83.2-98.6) to 100% (95% CI: 91.5-100). Furthermore, specimens with HCV genotypes 1b, 2a, 3a, 4a, 5a, 6 could be detected by HCV rapid diagnostic tests kits, whereas specimens with genotypes 1a and 2b could not be detected. Additionally, most HCV rapid diagnostic tests kits had great performance in diagnosing different titres and/or different bands samples, but some low S/CO value specimens may not be fully detected by few rapid diagnostic test kits. In conclusion, seven HCV rapid diagnostic tests reagents presented high sensitivity, specificity, good anti-interference and detection ability of early infection, which could meet the requirements of clinical HCV antibody screening.

Performance assessment of a widely used rapid diagnostic test CareStart™ compared to microscopy for the detection of Plasmodium in asymptomatic patients in the Western region of Cameroon

While malaria remains a serious public health concern, its rapid or prompt diagnosis in remote areas is important in the fight against the disease. The study aimed to evaluate the performance of widely used Rapid Diagnostic Test (RDT) kits for routinely detection of Plasmodium asymptomatic patients. A total of 400 asymptomatic participants of both sexes aged between 1-89 years from Menoua Division (Santchou and Dschang) were tested for malaria infection using both microscopy and CareStart™ RDT. The prevalence of malaria was higher when using the standard gold tool (Microscopy) (26.0%) compared to RDT (21.8%) with a significant difference (P < 0.05). However, a strong agreement was observed between both tests (kappa = 0.883; P < 0.0001). RDT CareStart™ sensitivity and specificity were 83.65% and 100% respectively while the positive predictive value and negative predictive value were 100% and 95.57% respectively. RDT sensitivity increased with parasite density while false negative (40.4%; n = 17) were observed only when parasite density was low (<500 parasites per microliter of blood). RDT kits appear to be good tools in areas where malaria diagnosis through microscopy is not feasible. However, the low sensibility observed when parasite density is low could be a concern.

Cost-effectiveness and budget impact analysis of facility-based screening and treatment of hepatitis C in Punjab state of India

ObjectiveDespite treatment availability, chronic hepatitis C virus (HCV) public health burden is rising in India due to lack of timely diagnosis. Therefore, we aim to assess incremental cost per quality-adjusted...

Comparative Performance of Different Malaria Diagnostic Tools among Pregnant Cohorts in Onitsha Southeast Nigeria

Background of Study: The reliability of microscopic techniques has become questionable in most endemic regions in Africa leading to its decreased utilization and increased utilization of RDT kits and other laboratory-based methods. Objective: To evaluate the performance of Rapid Diagnostic Test (RDT) kits and nest Polymerase Chain Reaction (nPCR) methods in detecting malaria infections among pregnant women visiting private hospitals in Onitsha district area of Anambra State, South-Eastern Nigeria. Methods: A total of 100 blood samples of pregnant women submitted to medical laboratory units of private maternal hospitals for malaria diagnosis in Onitsha district area were randomly selected for this study. Diagnosis was through microscopy, RDT kit (SD Bioline Pf-only test) and nPCR. Results: Pregnant cohorts had 95, 90 and 12 positive samples confirmed through microscopy RDT and nPCR respectively. RDT had a sensitivity and specificity of 89.47% and 0% while nPCR recorded sensitivity and specificity of 12.63% and 100% respectively. RDT and nPCR have a positive predictive value (PPV) of 94.44% of 100% respectively. Conclusion: This study revealed that nPCR is more efficient and reliable when compared with RDT in the diagnosis of malaria infection, having recorded the highest value for positive predictive value (PPV) and specificity than the RDT among pregnant women.

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.

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.

Detection of Syphilis among HIV-Positive and HIV-Negative Patients in Ogun State, Nigeria

Background: Syphilis is still one of the major causes of death in some developing countries where HIV infection is also prevalent. The aim of this study was to determine the prevalence of syphilis among HIV positive and negative women in Ogun state. Methods: The serum samples of 240 (120 HIV Positive and 120 HIV Negative) consenting female participants were collected randomly and screened using two brands of Syphilis Immunochromatographic rapid diagnostic test (RDT) kits: LabAcon (Biotest Biotech Co., Ltd., Hangzhou, China) and Perfect (Abbon Health care, Ltd, UK). The demographic and clinical information of the participants were collected using a structured questionnaire. Statistical analysis was carried out using SPSS Statistics software package (version 18.0). One-way analysis of variance (ANOVA) and Tukey-Kramer Multiple Comparisons Test was used to test for significant differences in the prevalence of syphilis among the study population. P values &lt;0.05 was considered significant. Results: The outcome of the study shows that Syphilis exist among both HIV-positive and HIV-negative women in Ogun State with a prevalence rate of 11.7% and 4.2%, respectively using LabAcon RDT kit and also 9.2% and 2.5%, respectively, using Perfect RDT kit. The occurrence of syphilis was significantly (P&lt;0.05) higher among HIV-positive subjects compared to their 2 Annals of Immunology &amp; Immunotherapy Enitan SS, et al. Detection of Syphilis among HIV-Positive and HIV-Negative Patients in Ogun State, Nigeria. Ann Immunol Immunother 2021, 3(2): 000144. Copyright© Enitan SS, et al. HIV-negative counterparts. All the participants who tested positive to syphilis were symptomatic regardless of their HIV status. Significant risk factors of syphilis associated with HIV infected subjects include past history of sexually transmitted infection and engagement in unprotected sex (p&lt;0.05). Conclusion: Syphilis exists among both HIV-positive and HIV-negative women in Ogun State and therefore the need for routine screening for syphilis among women, especially those infected with HIV cannot be over-emphasized.

Diagnostic accuracy of commercially available immunochromatographic rapid tests for diagnosis of dengue in India.

There is limited evidence regarding the accuracy of dengue rapid diagnostic kits despite their extensive use in India. We evaluated the performance of four immunochromatographic Rapid Diagnostic Test (RDTs) kits: Multisure dengue Ab/Ag rapid test (MP biomedicals; MP), Dengucheck combo (Zephyr Biomedicals; ZB), SD bioline dengue duo (Alere; SD) and Dengue day 1 test (J Mitra; JM). This is a laboratory-based diagnostic evaluation study. Rapid tests results were compared to reference non-structural (NS1) antigen or immunoglobulin M (IgM) enzyme-linked immunosorbent assay (ELISA) results of 241 dengue-positive samples and 247 dengue-negative samples. Sensitivity and specificity of NS1 and IgM components of each RDT were calculated separately and in combination (either NS1 or IgM positive) against reference standard ELISA. A total of 238, 226, 208, and 146 reference NS1 ELISA samples were tested with MP, ZB, SD, and JM tests, respectively. In comparison to the NS1 ELISA reference tests, the NS1 component of MP, ZB, SD, and JM RDTs demonstrated a sensitivity of 71.8%, 85.1%, 77.2% and 80.9% respectively and specificity of 90.1%, 92.8%, 96.1 %, and 93.6%, respectively. In comparison to the IgM ELISA reference test, the IgM component of RDTs showed a sensitivity of 40.0%, 50.3%, 47.3% and 20.0% respectively and specificity of 92.4%, 88.6%, 96.5%, and 92.2% respectively. Combining NS1 antigen and IgM antibody results led to sensitivities of 87.5%, 82.9%, 93.8% and 91.7% respectively, and specificities of 75.3%, 73.9%, 76.5%, and 80.0% respectively. Though specificities were acceptable, the sensitivities of each test were markedly lower than manufacturers' claims. These results also support the added value of combined antigen-and antibody-based RDTs for the diagnosis of acute dengue.

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.

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.