Evaluation of 2 Lateral Flow Rapid Tests in the Diagnosis of Chagas Disease in the Washington Metropolitan Area.
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SUBMITTER: Castro-Sesquen YE
PROVIDER: S-EPMC8047845 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe diversity of individuals at risk for Trypanosoma cruzi infection in the United States poses challenges for diagnosis. We evaluated the diagnostic accuracy of Food and Drug Administration (FDA)-cleared tests in the Washington Metropolitan area (WMA).MethodsIn total, 1514 individuals were evaluated (1078 from Mexico, Central and northern South America [TcI-predominant areas], and 436 from southern South America [TcII/V/VI-predominant areas]). Optical density (OD) values from the Hemagen EIA and Chagatest v.3 Wiener, and categorical results of the IgG-TESA-blot (Western blot with trypomastigote excretory-secretory antigen), and the Chagas detect plus (CDP), as well as information of area of origin were used to determine T. cruzi serostatus using latent class analysis.ResultsWe detected 2 latent class (LC) of seropositives with low (LC1) and high (LC2) antibody levels. A significantly lower number of seropositives were detected by the Wiener, IgG-TESA-blot, and CDP in LC1 (60.6%, P < .001, 93.1%, P = .014, and 84.9%, P = .002, respectively) as compared to LC2 (100%, 100%, and 98.2%, respectively). LC1 was the main type of seropositives in TcI-predominant areas, representing 65.0% of all seropositives as opposed to 22.8% in TcII/V/VI-predominant areas. The highest sensitivity was observed for the Hemagen (100%, 95% confidence interval [CI]: 96.2-100.0), but this test has a low specificity (90.4%, 95% CI: 88.7-91.9). The best balance between positive (90.9%, 95% CI: 83.5-95.1), and negative (99.9%, 95% CI: 99.4-99.9) predictive values was obtained with the Wiener.ConclusionsDeficiencies in current FDA-cleared assays were observed. Low antibody levels are the main type of seropositives in individuals from TcI-predominant areas, the most frequent immigrant group in the United States.
| S-EPMC8096267 | biostudies-literature
Project description:BackgroundChagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. The development of simplified diagnostic algorithms would enable progress in access to diagnosis; however, the current diagnostic algorithm relies on at least two laboratory-based tests that require qualified personnel, processing equipment, and infrastructure, which are still generally lacking at the primary care level. Rapid diagnostic tests (RDTs) for Chagas disease could simplify diagnosis, but their performance in the epidemiological context of Colombia is not well known.MethodologyA retrospective analytical observational study of RDTs was performed to estimate the operational characteristics of 11 commercially available RDTs designed for in vitro detection of anti-T. cruzi IgG antibodies. The study was performed under controlled laboratory conditions using human serum samples.Principal findingsEleven RDTs were assessed, ten using 585 serum samples and one using 551 serum samples. Employing the current national diagnostic algorithm as a reference standard for serological diagnosis of chronic infection, the sensitivity of the assessed RDTs ranged from 75.5% to 99.0% (95% CI 70.5-100), while specificity ranged from 70.9% to 100% (95% CI 65.3-100). Most tests (7/11, 63.6%) had sensitivity above 90%, and almost all (10/11, 90.9%) had specificity above 90%. Five RDTs had both sensitivity and specificity above 90%.Conclusions/significanceThe evaluation of these 11 commercially available RDTs under controlled laboratory conditions is a first step in the assessment of the diagnostic performance of RDTs in Colombia. As a next step, field studies will be conducted on available RDTs with sensitivity and specificity greater than 90% in this study, to evaluate performance in real world conditions, with the final goal to allow simplified diagnostic algorithms.
| S-EPMC10473487 | biostudies-literature
Project description:A diagnostic performance study comparing the only Food and Drug Administration-approved, point-of-care (POC) treponemal test (Syphilis Health Check) and the World Health Organization pre-qualified SD Bioline POC treponemal test against a treponemal hemagglutination test (TPHA) and a sequential algorithm of nontreponemal rapid plasma reagin and TPHA found both POC tests had >85% sensitivity compared with the TPHA and >85% sensitivity and >95% specificity compared with the rapid plasma reagin and TPHA standards.
| S-EPMC5026394 | biostudies-literature
Project description:Chagas disease is caused by the parasite Trypanosoma cruzi. It affects several million people, mainly in Latin America, and severe cardiac and/or digestive complications occur in ~30% of the chronically infected patients. Disease acute stage is mostly asymptomatic and infection goes undiagnosed. In the chronic phase direct parasite detection is hampered due to its concealed presence and diagnosis is achieved by serological methods, like ELISA or indirect hemagglutination assays. Agreement in at least two tests must be obtained due to parasite wide antigenic variability. These techniques require equipped labs and trained personnel and are not available in distant regions. As a result, many infected people often remain undiagnosed until it is too late, as the two available chemotherapies show diminished efficacy in the advanced chronic stage. Easy-to-use rapid diagnostic tests have been developed to be implemented in remote areas as an alternative to conventional tests. They do not need electricity, nor cold chain, they can return results within an hour and some even work with whole blood as sample, like Chagas Stat-Pak (ChemBio Inc.) and Chagas Detect Plus (InBIOS Inc.). Nonetheless, in order to qualify a rapidly diagnosed positive patient for treatment, conventional serological confirmation is obligatory, which might risk its start. In this study two rapid tests based on distinct antigen sets were used in parallel as a way to obtain a fast and conclusive Chagas disease diagnosis using whole blood samples. Chagas Stat-Pak and Chagas Detect Plus were validated by comparison with three conventional tests yielding 100% sensitivity and 99.3% specificity over 342 patients seeking Chagas disease diagnosis in a reference centre in Sucre (Bolivia). Combined used of RDTs in distant regions could substitute laborious conventional serology, allowing immediate treatment and favouring better adhesion to it.
| S-EPMC5391121 | biostudies-literature
Project description:Background: In industrialised countries diphtheria is a rare but still life-threatening disease with a recent increase in cases due to migration and zoonotic aspects. Due to the rarity of the disease, laboratory diagnosis of diphtheria is often carried out in central reference laboratories and involves the use of sophisticated equipment and specially trained personnel. The result of the diphtheria agent detection can usually be obtained after 5-6 days or more. Authors suggest a Lateral Flow Immunoassay (LFIA)-based laboratory algorithm for the diagnosis of diphtheria, which may render less time in issuing a result and could promote the testing be performed in laboratories closer to the patient. Methods: LFIA for diphtheria toxin (DT) detection was designed using a pair of monoclonal antibodies to receptor-binding subunit B of the DT, and validated with 322 corynebacterial cultures as well as 360 simulated diphtheria specimens. Simulated diphtheria specimens were obtained by spiking of human pharyngeal samples with test strains of corynebacteria. The simulated specimens were plated on selective tellurite agar and after 18-24 hours of incubation, grey/black colonies characteristic of the diphtheria corynebacteria were examined for the DT using LFIA. Results: The diagnostic sensitivity of the LFIA for DT detection on bacterial cultures was 99.35%, and the specificity was 100%. Also, the LFIA was positive for all pharyngeal samples with toxigenic strains and negative for all samples with non-toxigenic strains. For setting LFIA, a 6-hour culture on Elek broth was used; thus, under routine conditions, the causative agent of diphtheria could be detected within two working days after plating of the clinical specimen on the tellurite medium of primary inoculation. Conclusions: The availability of such a simple and reliable methodology will speed up and increase the accuracy of diphtheria diagnosis globally.
| S-EPMC10445807 | biostudies-literature
Project description:Our objective was to develop state and metropolitan area-based surveillance projects to describe the characteristics of those with ALS and to assist with evaluating the completeness of the National ALS Registry. Because the literature suggested that ethnic/racial minorities have lower incidence of ALS, three state and eight metropolitan areas were selected to over-represent ethnic/racial minorities to have a sufficient number of minority patients. Project activities relied on reports from medical providers and medical records abstraction. The project areas represented approximately 27% of the U.S.The combined racial and ethnic distribution of these areas is 64.4% white, 16.0% African-American, 6.7% Asian, and 28.3% Hispanic. Most neurologists did not diagnose or provide care for ALS patients. The number of unique patients reported was close to expected (5883 vs. 6673). Age and gender distribution of patients was similar to the literature. The crude average annual incidence rate was 1.52 per 100,000 person-years, CI 1.44-1.61, and the 2009 prevalence rate was 3.84 per 100,000 population, CI 3.70-3.97. In conclusion, this study represents the largest number of clinically diagnosed ALS patients reported by neurologists in the U.S. Comparison of these data with those in the National ALS Registry will help evaluate the completeness of administrative databases.
| S-EPMC4732418 | biostudies-other
Project description:As vaccination against SARS-CoV-2 progresses rapidly around the world, reliable detection of SARS-CoV-2 specific neutralizing antibodies (NAb) has become an indispensable component of serological diagnostics. We evaluated the performance of four commercially available tests, i.e. two lateral flow assays (Coris BioConcept COVID-19 Sero NP/RBD and Concile InfectCheck COVID-19 NAb) and two surrogate ELISA (sELISA) tests (EUROIMMUN SARS-CoV-2 NeutraLISA and AdipoGen SARS-CoV-2 Neutralizing Antibodies Detection Kit) in comparison with an in-house SARS-CoV-2 micro neutralization test as reference. A total of 334 sera were tested, including 30 samples collected prior to the emergence of SARS-CoV-2, 128 sera from convalescent patients as well as 176 sera from partially or fully vaccinated individuals. The overall sensitivity of LFAs differed and was 71.6% for the Coris and 98.4% for the Concile. In contrast, overall sensitivity of the NeutraLISA was 86 and 98% for the AdipoGen. All test showed the highest sensitivity when testing samples from fully vaccinated individuals with both sELISA achieving 100% sensitivity. Overall specificity was 89.3% for the Coris and only 58.3% for the Concile. Similarly, significant differences were observed for both sELISA, with an overall specificity of 82.1% for the NeutraLISA and only 54.8% for the AdipoGen. All tests showed a 100% specificity when testing negative control samples while specificities were lowest when testing samples from only partially vaccinated individuals.
| S-EPMC8854747 | biostudies-literature
Project description:BackgroundThe novel coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has quickly spread worldwide since its outbreak in December 2019. One of the primary measures for controlling the spread of SARS-CoV-2 infection is an accurate assay for its diagnosis. SARS-CoV-2 real-time PCR kits suffer from some limitations, including false-negative results in the clinic. Therefore, there is an urgent need for the development of a rapid antibody test kit for COVID-19 diagnosis.MethodsThe nuclear capsid protein (N) and spike protein 1 (S1) fragments of SARS-CoV-2 were expressed in Escherichia coli, and rapid antibody-based tests for the diagnosis of SARS-CoV-2 infection were developed. To evaluate their clinical applications, the serum from COVID-19 patients, suspected COVID-19 patients, recovering COVID-19 patients, patients with general fever or pulmonary infection, doctors and nurses who worked at the fever clinic, and health professionals was analyzed by the rapid antibody test kits. The serum from patients infected with Mycoplasma pneumoniae and patients with respiratory tract infection was further analyzed to test its cross-reactivity with other respiratory pathogens.ResultsA 47 kDa N protein and 67 kDa S1 fragment of SARS-CoV-2 were successfully expressed, purified, and renatured. The rapid antibody test with recombinant N protein showed higher positive rate than the rapid IgM antibody test with recombinant S1 protein. Clinical evaluation showed that the rapid antibody test kit with recombinant N protein had 88.56 % analytical sensitivity and 97.42 % specificity for COVID-19 patients, 53.48 % positive rate for suspected COVID-19 patients, 57.14 % positive rate for recovering COVID-19 patients, and 0.5-0.8 % cross-reactivity with other respiratory pathogens. The analytical sensitivity of the kit did not significantly differ in COVID-19 patients with different disease courses (p < 0.01).ConclusionsThe rapid antibody test kit with recombinant N protein has high specificity and analytical sensitivity, and can be used for the diagnosis of SARS-CoV-2 infection combined with RT-PCR.
| S-EPMC8381135 | biostudies-literature
Project description:ObjectiveThe goal of this systematic scoping review is to collect and summarise scientific evidence regarding the validity of two simultaneous immunochromatographic tests for the conclusive diagnosis of Chagas disease. The research was informed by the following review questions: Will the use of two rapid tests be a valid method for the definitive diagnosis of Chagas disease when compared with conventional serological tests? In what type of population has the operation of two rapid tests been tried for the diagnosis of Chagas disease? What are the biomedical and public health advantages of the diagnostic method resulting from the combination of two rapid tests over the conventional serological method? Will it be a cost-benefit strategy for the diagnosis of Chagas with respect to conventional serological tests?DesignSystematic scoping review.SettingA search of the published and unpublished literature in five databases was carried out, in order to identify, screen and select the studies included in this review.Results468 studies were identified, of which 46 were screened with a full-text reading, and finally, three articles were included in the review. All studies were in endemic countries with adult and paediatric populations (n=1133) and, together, they evaluated four different rapid tests. The rapid tests showed good sensitivity (97.4%-100%) and specificity (96.1%-100%) for the diagnosis of Chagas when used in combination and compared with the reference tests.ConclusionsThe simultaneous use of at least two immunochromatographic rapid tests is a valid option for the definitive diagnosis of chronic Chagas in endemic rural areas, as long as there are studies that previously evaluate their performance on the areas of implementation. Therefore, this could be an alternative to the current diagnostic standard. However, additional studies are still needed in more countries in order to provide further evidence and to investigate the cost-benefit.
| S-EPMC8559098 | biostudies-literature
Project description:BackgroundInfluenza virus mainly causes acute respiratory infections in humans. However, the diagnosis of influenza is not accurate based on clinical evidence, as the symptoms of flu are similar to other respiratory virus. The lateral-flow assay is a rapid method to detect influenza virus. But the effectiveness of the technique in detecting flu viruses is unclear. Hence, a meta-analysis would be performed to evaluate the accuracy of LFA in detecting influenza virus.MethodsRelevant literature was searched out in PubMed, Embase, Web of Science, and Cochrane Library databases with the keywords "lateral flow assay" and "flu virus". By Meta-DiSc software, pooled sensitivity, pooled specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), summary receiver operating characteristic curve (SROC), and area under the curve (AUC) can be calculated.ResultsThis meta-analysis contains 13 studies and 24 data. The pooled sensitivity and specificity of the influenza virus detected by LFA were 0.84 (95% CI: 0.82-0.86) and 0.97 (95% CI: 0.97-0.98), respectively. The pooled values of PLR, NLR, DOR, and SROC were 32.68 (17.16-62.24), 0.17 (0.13-0.24), 334.07 (144.27-773.53), and 0.9877. No publication bias was found.ConclusionsLFA exhibited high sensitivity and specificity in diagnosing influenza virus. It is a valuable alternative method which can diagnose influenza virus quickly. However, more evidence is required to confirm whether LFA is comparable to traditional methods for detecting the virus.
| S-EPMC7495160 | biostudies-literature