Test For Detection Research Articles

Comparative Analysis of Hemagglutination Inhibition and Plaque Reduction Neutralization Tests for Japanese Encephalitis Virus Antibody Detection

Japanese encephalitis (JE) is a zoonotic disease caused by the Japanese encephalitis virus (JEV), belonging to the Flaviviridae family. Diagnosis of Japanese encephalitis (JE) based on clinical signs alone is challenging due to the high proportion of subclinical cases. The Plaque Reduction Neutralization Test (PRNT) is considered the gold standard for detecting JE-specific antibodies because of its high specificity. However, PRNT is complex, time-consuming, and requires live viruses, limiting its applicability in routine diagnostics. In this study, we compared the sensitivity and correlation of the Hemagglutination Inhibition (HI) assay and PRNT for detecting JE antibodies in avian serum samples. We conducted a comparative analysis of the outcomes obtained from the PRNT and HI using 240 serum samples collected from 30 JEV-immunized avian subjects at various time points. Comparative analysis revealed a significant correlation between the HI and PRNT (R2 = 0.9321, p ≤ 0.0001). The Bland–Altman analysis also exhibited favorable concordance between the two assays. Consequently, HI may function as a viable substitute for PRNT in the screening of a substantial number of serum samples.

Naked-Eye Molecular Testing for the Detection of Xylella fastidiosa in Mallorca (Balearic Island) Almond Orchards by Colorimetric LAMP

Xylella fastidiosa (Xf) is a quarantine pathogen heavily affecting economically important crops worldwide. Different sequence types (STs) belonging to Xf subspecies are present in various areas of Spain, including the Balearic Islands, and cause the almond leaf scorch disease (ALSD) in Prunus spp. The increased demand for rapid tests for early detection of the pathogen should enforce strict containment measures. Molecular detection through isothermal amplification reactions enables simplified instrumentation and the use of raw nucleic acid extracts. Colorimetric loop-mediated isothermal amplification (cLAMP) was applied to rapidly detect Xf in naturally infected almonds on Mallorca Island (Spain), using a quick crude sap extraction without DNA purification. Following tissue homogenization, an alkaline treatment for target DNA extraction was conducted before the cLAMP test. The cLAMP assay was able to detect up to 100 CFU/mL of the Xf bacterial suspension diluted in healthy almond sap. The same crude extracts used in the cLAMP test were also tested by qPCR. An overall positive agreement of about 47% was observed between the results of the two techniques, while a decrease in cLAMP sensitivity was evident as the bacterial titer declined in infected plants over Cq > 26–27. This study shows the potential of the cLAMP application as a rapid and low-cost point-of-care diagnostic method for the timely monitoring of Xf directly in the field.

Solid-phase red cell adherence versus gel column agglutination: Is there any difference for the detection of alloantibodies associated with the JK system?

Detection of alloantibodies associated with the JK system may be tricky. They are nevertheless associated with transfusion reactions and their detection is crucial. Retrospectively and over a period of 7 years, we compared the results obtained using two different assays for antibody detection. We performed antibody detection testing with solid-phase red cell adherence (SPRCA). If positive, the antibody identification was carried out with the SPRCA and confirmed with the gel method in Coombs medium. In case of discrepant results occurring in recently transfused patients, we investigated these patients during the post-transfusion period. Fifty-five patients with anti-JK1 or anti-JK2 were identified out of which 41 were further analyzed. Both techniques clearly identified 10 alloantibodies. In 22 cases, the alloantibody identified by SPRCA was not observed with the gel method because of negative detection tests. In one case, none of the techniques identified the alloantibody and in 8 cases, the final result was inconclusive (1/41 with the SPRCA and 8/41 with the gel method). Two patients having a highly probable delayed hemolytic transfusion reaction (DHTR) were identified among the discrepant results. For both cases, anti-JK2 was clearly identified by the SPRCA but showed inconclusive reactions with the gel method. This study shows that in 29 out of 41 cases, the anti-JK1 or anti-JK2 identified with the SPRCA method were not with the gel method in Coombs medium. Eleven cases (11/29) were clinically significant and among them, 4 likely DHTRs and 2 highly probable DHTRs occurred.

Evaluation of the applicability of urine lateral flow immunochromatography tests for the detection of cocaine in plasma samples

IntroductionQualitative analysis of cocaine in urine is a common practice in emergency settings. However, positive results from urine screening tests do not necessarily indicate recent exposure. In this context, plasma is considered a more appropriate option due to its shorter detection window and better correlation with symptomatology. Therefore, the availability of rapid tests for this biological matrix is extremely relevant in the clinical and emergency context. MethodsA lateral flow immunochromatography test designed for analyzing cocaine in urine was evaluated for use with plasma samples. A total of 412 samples from suspected cases of intoxication were processed and tested. Concurrently, the samples were analyzed for cocaine and its metabolites, benzoylecgonine and ecgonine methyl ester, using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Reliability parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and efficiency, were calculated considering different cutoff values. ResultsApproximately 8.3 % of the samples tested positive in the immunoassay, while 10.2 % had a concentration greater than 5 ng/mL for at least one analyte in the LC-MS/MS analysis. Using benzoylecgonine as the target analyte with a cutoff of 40 ng/mL yielded the best reliability results, with 96.3 % sensitivity and 97.9 % specificity. Cocaine did not show satisfactory results, whereas ecgonine methyl ester, despite having 92.9 % sensitivity and 94.7 % specificity at its best cutoff (20 ng/mL), had a positive predictive value of only 38.2 %. ConclusionsThe study evaluated the suitability of using rapid urine tests for cocaine detection in plasma, offering a simple and quick drug screening method that is particularly useful in toxicological emergencies.

Psychosocial impact associated with a multicancer early detection test (PATHFINDER): a prospective, multicentre, cohort study.

PATHFINDER was a prospective cohort study of multicancer early detection (MCED) testing in an outpatient ambulatory population. The aim of this study is to report the patient-reported outcomes (PROs) collected as secondary and exploratory measures in the PATHFINDER study. PATHFINDER is a prospective, multicentre, cohort study that enrolled existing healthy ambulatory outpatients at seven health networks in the USA, including hospitals, academic medical centres, and integrated health systems. Enrolled adults were aged 50 years or older without clinical suspicion of cancer, with or without additional cancer risk factors (smoking history, genetic predisposition, or previous cancer diagnosis). The primary objective was time to diagnostic resolution after an MCED cancer signal detected (CSD) result and extent of testing pursued. The objectives of the 12-month PATHFINDER study reported here were assessment of patient-reported outcomes and perceptions with MCED testing (the effect of the MCED test result disclosure, general anxiety symptoms, health-related quality of life, and satisfaction with the MCED test). PRO instruments used included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty, and positive experience at MCED test result disclosure; PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms; and Short Form 12-Item Health Survey (SF-12v2) for health-related quality of life. Intentions towards adherence to guideline recommended screening was also assessed as an exploratory objective. This study is registered at ClinicalTrials.gov, NCT04241796, and is complete. Between Dec 12, 2019, and Dec 4, 2020, 6662 participants were recruited and 6621 eligible participants had analysable MCED test results (n=92 CSD and n=6529 no CSD [NCSD]). The majority of participants were women (4204 [63·5%] of 6621) and White (6071 [91·7%] of 6621). For participants who completed the MICRA at results disclosure, the mean total MICRA score was 28·4 (SD 14·9) for the 50 patients with a CSD result and 8·8 (7·2) for those with an NCSD result (n=5864 completed the full questionnaire). Mean general anxiety scores increased in true-positive and false-positive groups at results disclosure. The PROMIS anxiety true-positive group baseline score of 46·2 (SD 6·5; n=35) increased to 48·4 (7·3; n=19) and the scores in the false-positive group increased from 47·3 (7·3; n=52) to 49·7 (7·7; n=30). Mean scores in both groups returned towards baseline by end of study (true positive 46·8, SD 8·0; n=28; false positive 46·9, 8·1; n=41). Mean SF-12v2 mental component summary and scale scores were within the average general population range at all timepoints. A high proportion of participants (5749 [97·1%] of 5920) responded they were "satisfied", "very satisfied", or "extremely satisfied" with the MCED test, with this proportion highest in those with NCSD (5698 [97·2%] of 5861), followed by those with a true-positive MCED result (23 [92·0%] of 25) and those with a false-positive result (28 [82·4%] of 34). Most participants indicated they were likely or very likely to adhere to health-care providers' future cancer screening recommendations at end of study (5182 [95·6%] of 5418). The negative patient-reported effects associated with a CSD result from MCED testing were small and returned to baseline within 12 months for participants with or without a cancer diagnosis. PATHFINDER results indicate potential clinical benefit of early cancer detection and minimal patient distress associated with MCED testing. GRAIL.

Multi-Cancer Early Detection Tests: State of the Art and Implications for Radiologists.

Multi-cancer early detection (MCED) tests are already being marketed as noninvasive, convenient opportunities to test for multiple cancer types with a single blood sample. The technology varies-involving detection of circulating tumor DNA, fragments of DNA, RNA, or proteins unique to each targeted cancer. The priorities and tradeoffs of reaching diagnostic resolution in the setting of possible false positives and negatives remain under active study. Given the well-established role of imaging in lesion detection and characterization for most cancers, radiologists have an essential role to play in selecting diagnostic pathways, determining the validity of test results, resolving false-positive MCED test results, and evaluating tradeoffs for clinical policy. Appropriate access to and use of imaging tests will also factor into clinical guidelines. Thus, all clinicians potentially involved with MCED tests for cancer screening will need to weigh the benefits and harms of MCED testing, including consideration of how the tests will be used alongside or in place of other screening options, how diagnostic confirmation tests should be selected, and what the implications are for policy and reimbursement decisions. Further, patients will need regular support to make informed decisions about screening using MCED tests in the context of their personal cancer risks, health-related values, and access to care.

Point of view: Challenges in implementation of new immunotherapies for Alzheimer's disease.

The advancement of disease-modifying treatments (DMTs) for Alzheimer's disease (AD), along with the approval of three amyloid-targeting therapies in the US and several other countries, represents a significant development in the treatment landscape, offering new hope for addressing this once untreatable chronic progressive disease. However, significant challenges persist that could impede the successful integration of this class of drugs into clinical practice. These challenges include determining patient eligibility, appropriate use of diagnostic tools and genetic testing in patient care pathways, effective detection and monitoring of side effects, and improving the healthcare system's readiness by engaging both primary care and dementia specialists. Additionally, there are logistical concerns related to infrastructure, as well as cost-effectiveness and reimbursement issues. This article brings together insights from a diverse group of international researchers and dementia experts and outlines the potential challenges and opportunities, urging all stakeholders to prepare for the introduction of DMTs. We emphasize the need to develop appropriate use criteria, including patient characteristics, specifically for the European healthcare system, to ensure that treatments are administered to the most suitable patients. It is crucial to improve the skills and knowledge of physicians to accurately interpret biomarker results, share decision-making with patients, recognize treatment-related side effects, and monitor long-term treatment. We advocate for investment in patient registries and unbiased follow-up studies to better understand treatment effectiveness, evaluate treatment-related side effects, and optimize long-term treatment. Utilizing amyloid-targeting therapies as a starting point for combination therapies should also be a priority.

Thermal imaging based non-destructive testing for fault detection in cold spray additive manufacturing

Thermal imaging based non-destructive testing for fault detection in cold spray additive manufacturing

Integrating wastewater analysis and targeted clinical testing for early disease outbreak detection and an enhanced public health response

The combination of wastewater monitoring and targeted clinical testing enabled detection and containment of SARS-CoV-2 outbreaks in university dormitories. This integrated approach contributed to smart resource allocation and lower positivity rates.

Designing and evaluating a novel blood-brain barrier in vitro model of teleost for reproducing alterations in brain infecting

A new blood-brain barrier (BBB) in vitro model of tilapia (Oreochromis niloticus) was successfully established by co-culture with brain microvascular endothelial cell line TVEC-01 and brain astrocyte cell line TA-02 of tilapia. Experiments with the expression levels of BBB-related genes, TEER value detection and four-hour water-leaking test have shown that the BBB in vitro model has an excellent barrier effect. In bacterial penetration experiments, the pathogenic strain of Streptococcus agalactiae was able to pass through the BBB in vitro model and initiate a series of immune responses, among which TA-02 contributed to the expression of pro-inflammatory cytokines and TVEC-01 contributed to the expression of anti-inflammatory cytokines, providing an excellent research tool and theoretical basis for further study of meningitis. Moreover, the qRT-PCR and transmission electron microscopy revealed that the pathogenic strain of S. agalactiae effectively penetrated the BBB in vitro model of tilapia during early-stage infection without destroying tight junction integrity. This suggested that, in the initial phases of infection, the pathogenic strain of S. agalactiae may breach the BBB via a transcellular pathway rather than a paracellular pathway. Summarily, a novel BBB in vitro model of tilapia was successfully designed and evaluated for reproducing alterations in brain infecting.

Investigation of grain boundary segregation evolution and corrosion behavior in 7050 aluminum alloy under oscillating laser melting

The weld structures of 7xxx series aluminum alloy have been applied on aerospace, rail transport, petrochemical engineering, and other fields. However, the corrosion resistance of welded joint is usually reduced due to the microstructrue morphology of fusion zone (FZ). In this study, five oscillating modes were used to melt 7050 aluminum alloy, and the relationship between the microstructure and corrosion properties of different modes of FZ was analyzed. In particular, morphology observation, electron backscattered scattering detection (EBSD) test and phase analysis were carried out by SEM and TEM, and the grain boundary segregation, element distribution and grain characteristics under different modes were analyzed and compared. The relationship between laser beam oscillation mode, microstructure of FZ and corrosion resistance was established. It is concluded that the potential disparity between the precipitated phase and the grain, engendered by the variance in the concentration of the precipitated phase and the content of low-potential elements within the phase, exerts a decisive impact on the corrosion resistance of the material. The purpose of this study is to provide a new way to improve the corrosion resistance of 7050 aluminum alloy laser machined parts, and to meet the industrial needs of aerospace and other fields to the maximum extent.

Comparative Evaluation of Three Rapid Influenza Diagnostic Tests for Detection of Influenza A and B Viruses Using RT-PCR as Reference Method.

To evaluate the performance of three rapid influenza diagnostic tests (RIDTs) for detecting influenza A and B viruses compared to RT-PCR. A total of 291 subjects with acute respiratory infections were enrolled. Respiratory specimens were collected and tested for influenza A and B viruses using three RIDTs. The results were compared with those obtained using an RT-PCR assay from Shanghai Berger Medical Technology Co. Ltd. as the reference method. Among the 291 subjects, 119 (40.9%) tested positive for influenza A virus and 38 (13.1%) for influenza B virus by RT-PCR. The sensitivities of the three RIDTs for influenza A virus were 92.4%, 89.1%, and 79.8%, respectively, while their specificities were 98.8%, 98.8%, and 100%, respectively. For influenza B virus, the sensitivities of the three RIDTs were 92.1%, 92.1%, and 73.7%, respectively, and their specificities were 100%, 100%, and 100%, respectively. The positive predictive values (PPVs) for influenza A virus were 98.2%, 98.1%, and 100%, respectively, while the negative predictive values (NPVs) were 94.5%, 92.4%, and 86.9%, respectively. For influenza B virus, the PPVs were all 100%, and the NPVs were 99.2%, 99.2%, and 97.7%, respectively. The three evaluated RIDTs demonstrated high specificity but varied sensitivity for detecting influenza A and B viruses. Negative results from RIDTs should be confirmed by RT-PCR, especially during peak influenza seasons. The high PPVs suggest that positive RIDT results are reliable for influenza diagnosis, while the high NPVs indicate that negative results are more likely to be true negatives.

Group A β-hemolytic Streptococcal Pharyngitis: An Updated Review.

Group A ß-hemolytic Streptococcus (GABHS) is the leading bacterial cause of acute pharyngitis in children and adolescents worldwide. This article aims to familiarize clinicians with the clinical manifestations, evaluation, diagnosis, and management of GABHS pharyngitis. A search was conducted in December 2022 in PubMed Clinical Queries using the key term "group A β-hemolytic streptococcal pharyngitis". This review covers mainly literature published in the previous ten years. Children with GABHS pharyngitis typically present with an abrupt onset of fever, intense pain in the throat, pain on swallowing, an inflamed pharynx, enlarged and erythematous tonsils, a red and swollen uvula, enlarged tender anterior cervical lymph nodes. As clinical manifestations may not be specific, even experienced clinicians may have difficulties diagnosing GABHS pharyngitis solely based on epidemiologic or clinical grounds alone. Patients suspected of having GABHS pharyngitis should be confirmed by microbiologic testing (e.g., culture, rapid antigen detection test, molecular point-of-care test) of a throat swab specimen prior to the initiation of antimicrobial therapy. Microbiologic testing is generally unnecessary in patients with pharyngitis whose clinical and epidemiologic findings do not suggest GABHS. Clinical score systems such as the Centor score and McIssac score have been developed to help clinicians decide which patients should undergo diagnostic testing and reduce the unnecessary use of antimicrobials. Antimicrobial therapy should be initiated without delay once the diagnosis is confirmed. Oral penicillin V and amoxicillin remain the drugs of choice. For patients who have a non-anaphylactic allergy to penicillin, oral cephalosporin is an acceptable alternative. For patients with a history of immediate, anaphylactic-type hypersensitivity to penicillin, oral clindamycin, clarithromycin, and azithromycin are acceptable alternatives. Early diagnosis and antimicrobial treatment are recommended to prevent suppurative complications (e.g., cervical lymphadenitis, peritonsillar abscess) and non-suppurative complications (particularly rheumatic fever) as well as to reduce the severity of symptoms, to shorten the duration of the illness and to reduce disease transmission.

The psychological impact of screening with a multicancer early detection test.

The psychological impact of screening with a multicancer early detection test.

Integrated DC arc model and DC arc detection approach based on K‐line diagram and spectrum integral difference

AbstractIn the low voltage direct current (LVDC) systems, the occurrence of DC series arc faults poses a significant threat to the safe operation of the system. This paper develops an accurate arc model for the arc fault simulation. The proposed arc model consists the steady‐state impedance, high frequency characteristics, and dynamic characteristics of the arc. Additionally, this paper proposes an arc detection algorithm combining the K‐line diagram and the spectrum integral difference of the arc current in the LVDC systems. This algorithm can identify four circuit states: normal operation, arc fault, switching action, and load mutation, which addresses the challenge of arc fault detection in complex working conditions. The STM32F407 microcontroller is utilized to design a DC series arc fault detector. Online detection tests demonstrate that the arc faults can be accurately detected and isolated within 37 ms, meeting the requirement of the UL1699B standard, with an accuracy rate of 99.33%. These achievements not only enhance the safety of the LVDC systems but also provide valuable references for the development of arc fault detection technology.

Viruses and psychiatric disorders: We have not crossed the borderline from hypothesis to proof yet (Review).

Most psychiatric disorders are heterogeneous and are attributed to the synergistic action of a multitude of factors. It is generally accepted that psychiatric disorders are the outcome of interactions between genetic predisposition and environmental perturbations, which involve psychosocial stress, or alterations in the physiological state of the organism. A number of hypotheses have been presented on such environmental influences that may include direct insults such as injury, malnutrition and hostile living conditions, or indirect sequelae following infection from viruses such as influenza, arboviruses, enteroviruses and several herpesviruses, or the differential expression of human endogenous retroviruses. It is known that the concept of viruses is far more extensive than their perception as mere agents of acute infections, or chronic debilitating diseases, such as AIDS or some forms of cancer. Notably, an apparent causal connection between viruses and the pathophysiology of diseases has been suggested; however, it remains unclear as to how to establish this causal connection. There are inherent difficulties in answering this question with certainty, which may be due to the multitude of genetic and environmental influences that can lead to psychopathology; the latent state of chronic infection exhibited by a number of neurotropic viruses; the late onset of psychiatric disorders with respect to the acute phase of viral infection at which detection tests would be successful; the complexity of the virome; and the existence of thousands of viral species. The present review aims to provide an outline of the conclusions that have thus far been reached regarding a possible association between viral infection and psychiatric disease, and the obstacles confronted during the quest for the truth behind the role of viruses.

First report of hop stunt viroid infecting luffa and cantaloupe in Taiwan

Luffa (Luffa cylindrica (L.) M. Roem.) and cantaloupe (Cucumis melo L.) are economically important cucurbitaceous crops in Taiwan. In August 2018, luffa samples displaying leaf chlorosis and deformation were collected in Nantou while cantaloupe samples exhibiting the above suspected systemic viral-like symptoms were collected in Chiayi in October 2019, respectively. Reverse transcription (RT)-PCR tests were conducted to investigate potential viral infections in leaf samples from 12 luffa and nine cantaloupe plants. Total nucleic acids were extracted from symptomatic cucurbit tissues using the taco™ DNA/RNA extraction kit (GeneReach Biotechnology, Taiwan), followed by PCR or RT-PCR tests for virus detection. Seven sets of degenerate primers targeting viral genera reported in local cucurbit crops, including genera Begomovirus, Crinivirus, Cucumovirus, Polerovirus, Potyvirus, Orthotospovirus and Tobamovirus, were utilized. However, all tests yielded negative results. Consequently, degenerate primers targeting genus Pospiviroid or hop stunt viroid (HSVd)-specific primers were employed. Among these tests, only HSVd-specific primers HSVd-RTR_F/R (5’-GGAATTCTCGAGTTGCCGCA-3’/5’-CCGCGGCCCTCTCT-3’) (van Dorst and Peters 1974) successfully amplified DNA fragments of approximately 130 bp from 19 symptomatic samples (12 from luffa and 9 from cantaloupe), while normal leaf samples of luffa and cantaloupe tested negative. Based on known nucleotide sequences, primers were designed to amplify and obtain the full-length 303-nucleotide sequences of the HSVd genome derived from luffa (accession no. OP331278) and cantaloupe (accession no. OP331279). The two sequences exhibit a 98.7% nucleotide identity with each other while exhibiting 99.3% nucleotide identity with a cucumber isolate from Japan (X00524) (Sano et al. 1984) and 98.0% nucleotide identity with another isolate (X07405) from the Netherlands (Puchta et al. 1988). Comparisons with 13 HSVd citrus isolates from Taiwan revealed nucleotide similarities ranging from 96.1% to 99.0%. To confirm pathogenicity, Nicotiana benthamiana was chosen as the experimental isolation host. Mechanical inoculation of N. benthamiana with diluted sap (20 W/V) from diseased plants consistently produced leaf wrinkling and stunting symptoms in 10–60% of inoculated plants by 12 days post-inoculation (DPI). RT-PCR tests confirmed viroid infection. Additionally, luffa seedlings at the cotyledon stage back-inoculated with the purified HSVd luffa isolate developed leaf deformation symptoms 15–25 DPI, and the infection was confirmed by RT-PCR, fulfilling Koch’s postulates. HSVd infections have previously been reported in citrus and grapes in Taiwan (Lin et al. 2015). To our knowledge, this is the first report of HSVd infecting luffa and cantaloupe in Taiwan. The newly identified HSVd cucumber isolates represent a potential threat to cucurbit production and warrant further investigation.

Spatial and temporal analysis of West Nile virus infection in mosquito and human populations based on arboviral detection testing data

West Nile virus (WNV) is a mosquito-borne zoonotic flavivirus which often causes asymptomatic infection in humans but may develop into a deadly neuroinvasive disease. In this study, we aimed to investigate variables potentially associated with human WNV infection using human and mosquito WNV surveillance and monitoring datasets, established over 20 years, from 2003 to 2022, across the province of Ontario, Canada. We combined climatic and geographic data, mosquito surveillance data (n = 3010 sites), blood donation arboviral detection testing data in the human population, and demographic and socio-economic data from Canadian population censuses. We hypothesized that spatio-temporal indices related to mosquito vector habitat and phenology, in addition to human demographic and socio-economic factors, were associated with WNV infection in the human population. Our results show that high habitat suitability of the main WNV vector in southerly locations of this region, Cx. pipiens/restuans (IRR = 2.0), and variables related to lower income (IRR = 2.8), and shelter infrastructure spending (IRR = 0.7), were key risk factors associated with WNV infection among blood donors from 2003 to 2022 across Ontario (R2 = 0.67). These results may inform points of entry for practical intervention aimed at reducing risk of mosquito-borne pathogens in Canada.

Retrospective clinical performance evaluation of the Abbott Bioline HAT 2.0, a rapid diagnostic test for human African trypanosomiasis based on recombinant antigens

AbstractBackgroundRapid diagnostic tests for the serological detection of gambiense human African trypanosomiasis (gHAT) have been developed to overcome the limitations of the traditional screening method, CATT/T. b. gambiense. The Abbott Bioline human African trypanosomiasis (HAT) 2.0 rapid diagnostic test has recently been developed by Abbott using only recombinant antigens. The objective of this study was to evaluate its clinical sensitivity and specificity, in comparison with the other available rapid diagnostic tests and CATT.Methodology/Principal FindingsFor this study, archived plasma samples from 150 gHAT cases and 150 endemic controls originating from Chad, Guinea, the Democratic Republic of the Congo and Uganda were analysed on the following tests: CATT/T. b. gambiense, the HAT Sero K‐SeT, SD BIOLINE HAT and Abbott Bioline HAT 2.0 rapid diagnostic tests, and the immune trypanolysis test. The sensitivity and specificity of Abbott Bioline HAT 2.0 were 96.7% and 78.4%, respectively, and the sensitivity and specificity of SD BIOLINE HAT were 99.3% and 74.1%. The sensitivity and specificity of CATT were 98.7% and 89.2%. The sensitivity and specificity of HAT Sero K‐SeT were 99.3% and 81.3%.Conclusions/SignificanceThe sensitivity and specificity of the Abbott Bioline HAT 2.0 are comparable to those of its predecessors HAT Sero K‐SeT and SD BIOLINE HAT. However, considering the decreasing prevalence of gHAT, a higher specificity of the tests used for screening is desirable to improve their positive predictive value.

Diagnostic performance of Uromonitor and TERTpm ddPCR urine tests for the non-invasive detection of bladder cancer.

Uromonitor and urinary telomerase reverse transcriptase promoter mutation droplet digital PCR (uTERTpm ddPCR) are non-invasive tests designed to detect bladder cancer in urine. We aimed to compare the diagnostic performance of uTERTpm ddPCR, Uromonitor and urine cytology in detecting bladder cancer. Urine samples were collected prospectively from patients diagnosed with primary (n = 74) and recurrent bladder cancer (n = 20) or benign urological conditions (n = 48) prior to surgical resection. The samples were tested for bladder cancer via uTERTpm ddPCR, Uromonitor and urine cytology. The sensitivity, specificity, and predictive values were calculated for each test, including confidence intervals. The results were stratified by low-grade non-muscle-invasive bladder cancer, high-grade non-muscle-invasive bladder cancer and muscle-invasive bladder cancer. Compared with urine cytology (59.5%, p = 0.005) and Uromonitor (56.8%, p = 0.001), the uTERTpm ddPCR test had the highest sensitivity (79.7%) for the detection of primary bladder cancer. Specificity did not significantly differ. The uTERTpm ddPCR test exhibited superior diagnostic performance over urine cytology and Uromonitor, highlighting its potential for non-invasive primary bladder cancer diagnosis.