scholarly journals A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study

2021 ◽  
Vol 15 (2) ◽  
pp. e0009159
Author(s):  
Janejira Dinhuzen ◽  
Umaporn Limothai ◽  
Sasipha Tachaboon ◽  
Panadda Krairojananan ◽  
Bangon Laosatiankit ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Medical Science ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Case Definition ◽  
Serum Samples ◽  
Thai Population ◽  
Low Sensitivity ◽  
A Prospective Study ◽  
Post Onset

Background Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population. Methodology/Principal findings Ninety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and J.Mitra. The case definition was based on MAT, qPCR, and culture results. Diagnostic accuracy was determined based on the first day of enrollment in an overall analysis and stratified according to days post-onset of fever. The five RDTs had overall sensitivity ranging from 1.8% to 75% and specificity ranging from 52.3% to 97.7%. Leptocheck-WB had high sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4–6 post-onset of fever, while the specificity of all tests remained relatively stable at different days post-onset of fever. Conclusions/Significance The tested RDTs showed low sensitivity. Therefore, based on the present study, five commercially available RDTs might not be an appropriate test for acute leptospirosis screening in the Thai population.

scholarly journals Laboratory evaluation of the Chembio Dual Path Platform HIV-Syphilis Assay

2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Mireille B. Kalou ◽  
Arnold Castro ◽  
Amy Watson ◽  
Heather Jost ◽  
Stacy Clay ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Treponema Pallidum ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Laboratory Evaluation ◽  
Serum Samples ◽  
Operational Characteristics ◽  
High Risk Populations ◽  
Positive Results

Background: Use of rapid diagnostic tests for HIV and syphilis has increased remarkably in the last decade. As new rapid diagnostic tests become available, there is a continuous need to assess their performance and operational characteristics prior to use in clinical settings.Objectives: In this study, we evaluated the performance of the Chembio Dual Path Platform (DPP®) HIV–Syphilis Assay to accurately diagnose HIV, syphilis, and HIV/syphilis co-infection.Method: In 2013, 990 serum samples from the Georgia Public Health Laboratory in Atlanta, Georgia, United States were characterised for HIV and syphilis and used to evaluate the platform. HIV reference testing combined third-generation Enzyme Immunoassay and Western Blot, whereas reference testing for syphilis was conducted by the Treponema pallidum passive particle agglutination method and the TrepSure assay. We assessed the sensitivity and specificity of the DPP assay on this panel by comparing results with the HIV and syphilis reference testing algorithms.Results: For HIV, sensitivity was 99.8% and specificity was 98.4%; for syphilis, sensitivity was 98.8% and specificity was 99.4%. Of the 348 co-infected sera, 344 (98.9%) were detected accurately by the DPP assay, but 11 specimens had false-positive results (9 HIV and 2 syphilis) due to weak reactivity.Conclusion: In this evaluation, the Chembio DPP HIV–Syphilis Assay had high sensitivity and specificity for detecting both HIV and treponemal antibodies. Our results indicate that this assay could have a significant impact on the simultaneous screening of HIV and syphilis using a single test device for high-risk populations or pregnant women needing timely care and treatment.

scholarly journals Clinical overlap between malaria and pneumonia: can malaria rapid diagnostic test play a role?

2011 ◽  
Vol 5 (03) ◽  
pp. 199-203 ◽  
Author(s):  
Kingsley Nnanna Ukwaja ◽  
Olufemi B Aina ◽  
Ademola A Talabi
Keyword(s):  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Diagnostic Tests ◽  
Health Centre ◽  
Rapid Diagnostic Tests ◽  
Case Definition ◽  
Sub Saharan Africa ◽  
Malaria Rapid Diagnostic Test ◽  
Chi Square ◽  
Symptom Overlap

Introduction: Malaria and pneumonia account for 40% of mortality among children under five years of age in sub-Saharan Africa. Due to lack of diagnostic facilities, their management is based on the integrated management of childhood illnesses (IMCI) strategy. Symptoms of malaria and pneumonia overlap in African children, necessitating dual IMCI classifications at health centres and treatment with both antibiotics and antimalarials. This study determined the prevalence of malaria-pneumonia symptom overlap and confirmed the diagnosis of malaria in these cases using a rapid diagnostic test. Methodology: Consecutive consultations of 1,216 children (two months to five years old) were documented over a three-month period in a comprehensive health centre. Malaria rapid diagnostic tests were conducted only for children who had symptom overlap. Results: Of the 1,216 children enrolled, 1,090 (90%) reported cough or fever. Among the children fulfilling the malaria case definition, 284 (30%) also met the pneumonia case definition. Twenty-three percent (284) of all children enrolled met the criteria for both malaria and pneumonia. However, only 130 (46%) of them had a positive result for malaria using a malaria rapid diagnostic test. During a malaria-pneumonia overlap, female children (chi-square 5.9, P = 0.01) and children ≥ one year (chi-square 4.8, P = 0.003) were more likely to seek care within two days of fever. Conclusion: Dual treatment with antimalarials and antibiotics in children with malaria-pneumonia overlap may result in unnecessary over-prescription of antimalarial medications. Use of rapid diagnostic tests in their management can potentially avoid over-prescribing of malaria medications.

scholarly journals Comparison of Coombs Gel Test with ELISA and Standard Tube Agglutination Tests Used in Serological Diagnosis of Brucellosis

2020 ◽  
Vol 2 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Cigdem Akalan Kuyumcu ◽  
Serpil Erol ◽  
Rıza Adaleti ◽  
Seniha Senbayrak ◽  
Secil Deniz ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Serological Test ◽  
High Sensitivity ◽  
Serological Diagnosis ◽  
Control Groups ◽  
Serum Samples ◽  
Serological Tests ◽  
Reliable Test ◽  
And Control

Objective: Serological tests are the most commonly used tests in the diagnosis of brucellosis; however, each serological test has some drawbacks. In this study, we aimed to determine the value of the Brucella Coombs gel test (BCGT) in the serological diagnosis of brucellosis in comparison with Standard tube agglutination (STA) and ELISA tests. Materials and Methods: The study included 42 patients who were considered to have brucellosis as a preliminary diagnosis. BCGT, Brucella-IgM/IgG ELISA, and STA tests were performed from serum samples of the patients. The correlation of the diagnostic tests was analyzed using Cohen’s Kappa Analysis.  Results: Twenty-seven (64.2%) of 42 patients were diagnosed with brucellosis according to their medical history and clinical and serological tests. The sensitivity and specificity of BCGT to diagnose brucellosis was 96.2%, and 100%, respectively. The sensitivity and specificity for the diagnosis of brucellosis 62.9% and 100% for STA, respectively; 33.3% and 66.6% for Brucella-IgM; and 66.6% and 100% for Brucella-IgG. BCGT was significantly correlated with STA (κ= 0.590) and Brucella-IgG (κ=0.539) Conclusion: BCGT can be utilized as a simple and reliable test in the diagnosis of brucellosis with high sensitivity and specificity. Nevertheless, the sensitivity and specificity of BCGT should be demonstrated by comprehensive studies, including culture-confirmed cases and control groups.

scholarly journals Sensitivity and specificity of commercially available rapid diagnostic tests for viral hepatitis B and C screening in serum samples

PLoS ONE ◽  
2020 ◽  
Vol 15 (7) ◽  
pp. e0235036
Author(s):  
Ganbolor Jargalsaikhan ◽  
Miriam Eichner ◽  
Delgerbat Boldbaatar ◽  
Purevjargal Bat-Ulzii ◽  
Oyungerel Lkhagva-Ochir ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Viral Hepatitis ◽  
Sensitivity And Specificity ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Serum Samples ◽  
Viral Hepatitis B

scholarly journals Association of the waist-hip ratio with plasma adiponectin related to coronary artery disease

2018 ◽  
Vol 17 (2) ◽  
pp. 290-295
Author(s):  
Premtim Rashiti ◽  
Ibrahim Behluli ◽  
Albiona Bytyçi
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Medical Science ◽  
Control Group ◽  
Serum Samples ◽  
Waist Hip Ratio ◽  
Significant Difference ◽  
Artery Disease ◽  
A Prospective Study ◽  
And Control

Objective: By enrolling a prospective study of 82 patients that underwent non-urgent coronary angiography for coronary artery disease (CAD), it is aimed to investigate the correlation between adiponectin and waist-hip-ratio with severity of CAD.Materials and methods: The results of the angiography, divided the patients into two groups, patients admitted with a diagnosis of CAD and non-CAD. In the conducted hospital based research, two groups were involved: the study group with documented angiographically CAD and control group without angiographic evidence of CAD. Some of the baseline adiponectin levels in stored serum samples of all patients, anthropometric and biochemical risk factors were assessed in both groups.Result and discussion: As the result, we have seen the presence of CAD that was associated with current smoking, male gender, waist–hip ratio (WHR).While, no significant difference between median adiponectin levels at baseline were observed between cases and controls.Conclusion: There is a significant positive correlation between waist - hip ratio and presence of severity of coronary artery disease.Bangladesh Journal of Medical Science Vol.17(2) 2018 p.290-295

scholarly journals Prozone-like phenomenon in travellers with fatal malaria: report of two cases

2015 ◽  
Vol 9 (03) ◽  
pp. 321-324 ◽  
Author(s):  
Lurdes Santos ◽  
Nuno Rocha Pereira ◽  
Paulo Andrade ◽  
Paulo Figueiredo Dias ◽  
Carlos Lima Alves ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
False Negative ◽  
Specific Antigen ◽  
Malaria Diagnosis ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Microscopy Observation ◽  
Negative Results ◽  
False Negative Results ◽  
Potential Benefits

Malaria diagnosis remains a concern in non-endemic countries, with rapid diagnosis being crucial to improve patients’ outcome. Rapid diagnostic tests have high sensitivity but they also have flaws and false-negative results that might jeopardize malaria diagnosis. Some false-negative results might relate to a prozone-like effect. The authors describe two patients with false-negative rapid diagnostic tests in which a prozone-like effect might have been involved. The authors highlight that these tests should not be used without accompanying light microscopy observation of blood films and discuss potential benefits of using rapid diagnostic tests with more than one specific antigen for Plasmodium falciparum.

scholarly journals Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

2021 ◽  
Vol 26 (44) ◽  
Author(s):  
Heinrich Scheiblauer ◽  
Angela Filomena ◽  
Andreas Nitsche ◽  
Andreas Puyskens ◽  
Victor M Corman ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Market Access ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Lower Sensitivity ◽  
Viral Loads ◽  
Sensitivity Evaluation ◽  
Wide Range ◽  
German Healthcare System ◽  
Minimum Sensitivity

Introduction Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims. Aim We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany. Methods We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system. Results The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30. Conclusions This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

scholarly journals Using prenatal blood samples to validate COVID-19 rapid serologic tests

2020 ◽  
Author(s):  
Jackeline Alger ◽  
Maria Luisa Cafferata ◽  
Tito Alvarado ◽  
Alvaro Ciganda ◽  
Arturo Corrales ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Population Based ◽  
Cross Reactivity ◽  
Rapid Diagnostic Tests ◽  
Serum Samples ◽  
Serologic Tests ◽  
Rapid Tests ◽  
Unique Source ◽  
Blood Specimens ◽  
One Year

Abstract IntroductionBackground cross-reactivity with other coronaviruses may reduce the specificity of COVID-19 rapid serologic tests. Blood collected during prenatal care is a unique source of population-based samples appropriate for validation studies. We used stored 2018 serum samples from an existing pregnancy cohort study to evaluate the specificity of COVID-19 serologic rapid diagnostic tests. MethodsWe randomly selected 120 stored serum samples from pregnant women enrolled in a cohort in 2018, at least one year before the COVID-19 pandemic. We used stored serum to evaluate four lateral flow rapid diagnostic tests, following manufacturers’ instructions. Pictures were taken for all tests and read by two blinded trained evaluators. Results We evaluated 120, 80, 90, and 90 samples, respectively. Specificity for both IgM and IgG was 100% for the first two tests. The third test had a specificity of 98.9% for IgM and 94.4% for IgG. The fourth test had a specificity of 88.9% for IgM and 100% for IgG.Discussion COVID-19 serologic rapid tests are of variable specificity. Blood specimens from sentinel prenatal clinics provide an opportunity to validate serologic tests with population-based samples.

scholarly journals Correlation of SARS-CoV-2 nucleocapsid antigen and RNA concentrations in nasopharyngeal samples from children and adults using an ultrasensitive and quantitative antigen assay

2021 ◽  
Author(s):  
Nira R. Pollock ◽  
Timothy J. Savage ◽  
Hanna Wardell ◽  
Rose A. Lee ◽  
Anu Mathew ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Rapid Diagnostic Tests ◽  
Clinical Samples ◽  
New Approach ◽  
Antigen Assay ◽  
Adults And Children ◽  
Electrochemiluminescence Immunoassay ◽  
Insight Into

Background: Diagnosis of COVID-19 by PCR offers high sensitivity, but the utility of detecting samples with high cycle threshold (Ct) values remains controversial. Currently available rapid diagnostic tests (RDTs) for SARS-CoV-2 nucleocapsid antigens (Ag) have sensitivity well below PCR. The correlation of Ag and RNA quantities in clinical nasopharyngeal (NP) samples is unknown. Methods: An ultrasensitive, quantitative electrochemiluminescence immunoassay for SARS-CoV-2 nucleocapsid (the MSD® S-PLEX® CoV-2 N assay) was used to measure Ag in clinical NP samples from adults and children previously tested by PCR. Results: The S-PLEX Ag assay had a limit of detection (LOD) of 0.16 pg/mL and a cutoff of 0.32 pg/mL. Ag concentrations measured in clinical NP samples (collected in 3.0 mL media) ranged from less than 160 fg/mL to 2.7 ug/mL. Log-transformed Ag concentrations correlated tightly with Ct values. In 35 adult and 101 pediatric PCR-positive samples, sensitivity was 91% (95% CI, 77-98%) and 79% (70-87%), respectively. In samples with Ct ≤ 35, sensitivity was 100% (88-100%) and 96% (88-99%), respectively. In 50 adult and 40 pediatric PCR-negative specimens, specificity was 100% (93-100%) and 98% (87-100%), respectively. Conclusions: Nucleocapsid concentrations in clinical NP samples span 8 orders of magnitude and correlate closely with RNA concentrations (Ct values). The S-PLEX Ag assay had 96-100% sensitivity in samples from children and adults with Ct values ≤ 35, and 98-100% specificity. These results clarify Ag concentration distributions in clinical samples, providing insight into the performance of Ag RDTs and offering a new approach to diagnosis of COVID-19.

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