scholarly journals Evaluation of Mycobacterium tuberculosis lipoarabinomannan antigen assay and rapid serology blood test for the diagnosis of bovine tuberculosis in Ethiopia

2019 ◽  
Vol 15 (1) ◽  
Author(s):  
Aboma Zewude ◽  
Temesgen Mohammed ◽  
Lemma Terfassa ◽  
W. Garrett Hunt ◽  
Xueliang Pan ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Gold Standard ◽  
Bovine Tuberculosis ◽  
Blood Test ◽  
Point Of Care ◽  
Rapid Test ◽  
Tuberculin Test ◽  
Receiver Operating Curve ◽  
Diagnostic Tools ◽  
Ifn Γ

Abstract Background Bovine tuberculosis (bTB) is prevalent in dairy cattle in Ethiopia. Currently used diagnostic tools such as the single intradermal comparative tuberculin test (SICTT) are time consuming and labor intensive. A rapid, easy-to-use and cost-effective diagnostic test would greatly contribute to the control of bTB in developing countries like Ethiopia. In the present study, two point-of-care diagnostic tests were evaluated for the detection of bTB: LIONEX® Animal TB Rapid test, a membrane-based test for the detection of antibodies to Mycobacterium bovis in blood and ALERE® Determine TB Lipoarabinomannan (LAM) Ag, an immunoassay for the detection of lipoarabinomannan (LAM) antigen (Ag) of mycobacteria in urine. A combination of the SICTT and gamma interferon (IFN-γ) test was used as the gold standard for the validation of these point-of-care tests, as it was not feasible to slaughter the study animals to carry out the historical gold standard of mycobacterial culture. A total of 175 heads of cattle having three different bTB infection categories (positive SICTT, negative SICTT, and unknown SICTT status) were used for this study. Result The sensitivity and specificity of TB LAM Ag were 72.2% (95% CI = 62.2, 80.4) and 98.8% (95% CI = 93.6, 99.7), respectively, while the sensitivity and specificity of the LIONEX Animal TB rapid test assay were 54% (95% CI = 44.1 64.3) and 98.8% (95% CI = 93.6, 99.7) respectively. The agreement between TB LAM Ag and SICTT was higher (κ = 0.85; 95% CI = 0.65–0.94) than between TB LAM Ag and IFN-γ (κ = 0.67; 95% CI = 0.52–0.81). The agreement between LIONEX Animals TB Rapid blood test and SICTT was substantial, (κ = 0.63; 95% CI = 0.49–0.77) while the agreement between LIONEX Animal TB rapid blood test and IFN-γ test was moderate (κ = 0.53; 95% CI = 0.40–0.67). Analysis of receiver operating curve (ROC) indicated that the area under the ROC curve (AUC) for TB LAM Ag was 0.85 (95% CI = 0.79–0.91) while it was 0.76 (95% CI; =0.69–0.83) for LIONEX Animal TB rapid test assay. Conclusion This study showed that TB LAM Ag had a better diagnostic performance and could potentially be used as ancillary either to SICTT or IFN-γ test for diagnosis of bTB.

scholarly journals Using of Gamma Interferon γ-IFN and Multiplex PCR (m-PCR) for Detection of Bovine Tuberculosis in Dairy Herds in Egypt

2021 ◽  
Vol 10 (3) ◽  
pp. 229-233
Keyword(s):  
Multiplex Pcr ◽  
Sensitivity And Specificity ◽  
Bovine Tuberculosis ◽  
Genomic Sequence ◽  
Tuberculin Test ◽  
Interferon Γ ◽  
Rapid Identification ◽  
Gamma Interferon ◽  
Diagnostic Tools ◽  
Assay Sensitivity

Many diagnostic tools are essential for Mycobacterium bovis (M. bovis) eradication program. This study aimed to apply γ-IFN assay to detect bovine tuberculosis and multiplex PCR (m-PCR) for rapid identification of Mycobacterial isolates. A total no. of 150 cattle in 10 small farms at different Governorates in Egypt, were previously gave suspected results with comparative cervical tuberculin test (SICCT), they retested after 60 days later again with SICCT and bovine gamma-interferon (γ-IFN) immunoassay. Eighty-seven (58%) out of total 150 animals were +ve reactors by SICCT test while 80 (53.3%) animals gave +ve γ-IFN assay. The isolated M. bovis by conventional culturing and identification tests were +ve 55 (63.2%) out 87. The γ-IFN assay sensitivity and specificity gave 82.9% and 93.8% respectively. For rapid identification of different mycobacterial isolates using m-PCR two set of primers were used. The first set gave 123bp DNA PCR product expressing IS6110 insertion element for Mycobacterium tuberculosis (MTBC). The other one gave 500bp from RvD1Rv2031c genomic sequence definite to M. bovis. M-PCR findings were in a concordance with results of conventional culturing and identification tests with high sensitivity and specificity (100%). From this study, it is concluded that diagnosis of bovine tuberculosis (BTB) used tuberculin test and γ-IFN assay with m-PCR for rapid identification M. bovis isolates in living herds.

scholarly journals Nasal swab real-time PCR is not suitable for in vivo diagnosis of bovine tuberculosis

2017 ◽  
Vol 37 (6) ◽  
pp. 549-554
Author(s):  
Fabiana Q. Mayer ◽  
Emily M. dos Reis ◽  
André Vinícius A. Bezerra ◽  
Rogério O. Rodrigues ◽  
Thais Michel ◽  
...  
Keyword(s):  
Real Time ◽  
Sensitivity And Specificity ◽  
Real Time Pcr ◽  
Bovine Tuberculosis ◽  
Tuberculin Test ◽  
Disease Diagnosis ◽  
Economic Losses ◽  
Nasal Swabs ◽  
In Vivo Diagnosis

ABSTRACT: Bovine tuberculosis (bTB) is a zoonosis causing economic losses and public health risks in many countries. The disease diagnosis in live animals is performed by intradermal tuberculin test, which is based on delayed hypersensitivity reactions. As tuberculosis has complex immune response, this test has limitations in sensitivity and specificity. This study sought to test an alternative approach for in vivo diagnosis of bovine tuberculosis, based on real-time polymerase chain reaction (PCR). DNA samples, extracted from nasal swabs of live cows, were used for SYBR® Green real-time PCR, which is able to differentiate between Mycobacterium tuberculosis and Mycobacterium avium complexes. Statistical analysis was performed to compare the results of tuberculin test, the in vivo gold standard bTB diagnosis method, with real-time PCR, thereby determining the specificity and sensitivity of molecular method. Cervical comparative test (CCT) was performed in 238 animals, of which 193 had suitable DNA from nasal swabs for molecular analysis, as indicated by amplification of glyceraldehyde-3-phosphate dehydrogenase (GAPDH) gene, and were included in the study. In total, 25 (10.5%) of the animals were CCT reactive, of which none was positive in the molecular test. Of the 168 CCT negative animals, four were positive for M. tuberculosis complex at real time PCR from nasal swabs. The comparison of these results generated values of sensitivity and specificity of 0% and 97.6%, respectively; moreover, low coefficients of agreement and correlation (-0.029 and -0.049, respectively) between the results obtained with both tests were also observed. This study showed that real-time PCR from nasal swabs is not suitable for in vivo diagnosis of bovine tuberculosis; thus tuberculin skin test is still the best option for this purpose.

scholarly journals Developing RT-LAMP Assays for Detection of SARS-CoV-2 in Saliva

2021 ◽  
Author(s):  
Xin Huang ◽  
Gongyu Tang ◽  
Nahed Ismail ◽  
Xiaowei Wang
Keyword(s):  
Sensitivity And Specificity ◽  
Gold Standard ◽  
Reliable Method ◽  
Rapid Test ◽  
Rna Isolation ◽  
Current Crisis ◽  
Design Algorithm ◽  
Assay Performance ◽  
Total Agreement ◽  
S Genes

The coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has killed millions of people worldwide. The current crisis has created an unprecedented demand for rapid test of SARS-CoV-2 infection. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a fast and convenient method to amplify and identify the transcripts of a targeted pathogen. However, the sensitivity and specificity of RT-LAMP were generally regarded as inferior when compared with the gold standard RT-qPCR. To address this issue, we combined bioinformatic and experimental analyses to improve the assay performance for COVID-19 diagnosis. First, we developed an improved algorithm to design LAMP primers targeting the nucleocapsid (N), membrane (M), and spike (S) genes of SARS-CoV-2. Next, we rigorously validated these new assays for their efficacy and specificity. Further, we demonstrated that multiplexed RT-LAMP assays could directly detect as low as a few copies of SARS-CoV-2 RNA in saliva, without the need of RNA isolation. Importantly, further testing using saliva samples from COVID-19 patients indicated that the new RT-LAMP assays were in total agreement in sensitivity and specificity with standard RT-qPCR. In summary, our new LAMP primer design algorithm along with the validated assays provide a fast and reliable method for the diagnosis of COVID-19 cases.

scholarly journals Performance of SARS-CoV-2 Serology tests: Are they good enough?

2020 ◽  
Author(s):  
Isabelle Piec ◽  
Emma English ◽  
M Annette Thomas ◽  
Samir Dervisevic ◽  
William D Fraser ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Respiratory Infections ◽  
Point Of Care ◽  
False Negative ◽  
Rapid Test ◽  
Diagnostic Sensitivity ◽  
Medical Community ◽  
Antibody Detection ◽  
Serological Tests ◽  
Negative Results

AbstractBackgroundIn the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations.MethodsSARS-CoV-2 patient samples (n=43) were analysed alongside pre-pandemic control specimen (n=50), confirmed respiratory infections (n=50), inflammatory polyarthritis (n=22) and positive for thyroid stimulating immunoglobulin (n=30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen.ResultsEDI and EuroImmun imprecision was 0.02-14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2% - 8.1% and 8.2% - 9.6% respectively. Diagnostic sensitivity of the assays were 100% (CI: 80-100%) for Abbott, EDI and EuroImmun and 95% (CI: 73-100%) for DiaSorin at ≥14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI: 91-100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%.ConclusionsSerological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.

scholarly journals 732. Sensitivity and Specificity of Point of Care Lung Ultrasound vs. Chest X-Ray for the Diagnosis of Pediatric Pneumonia in Limited resource settings: The Zambia Experience

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S464-S464
Author(s):  
Ingrid Y Camelo ◽  
Rachel Pieciak ◽  
Ilse castro-aragon ◽  
Bindu Setty ◽  
Lauren Etter ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Predictive Value ◽  
Gold Standard ◽  
Point Of Care ◽  
Severe Pneumonia ◽  
Limited Resource ◽  
Ultrasound Images ◽  
X Ray ◽  
Pediatric Pneumonia ◽  
Chest X Ray

Abstract Background Pediatric pneumonia is the leading cause of child mortality in low-income countries. Pneumonia diagnosis is a challenge. Chest x-ray (CXR) is considered the gold standard, but it exposes children to ionizing radiation, and access to CXR is limited to hospital settings. Lung Point of Care Ultrasound (POCUS) is a portable and non-radiating alternative to CXR. Methods We enrolled 200 children aged 1-59 months from the University Teaching Hospital (UTH) Emergency Department (ED) in Lusaka, Zambia who met the WHO (World Health Organization) case definition for severe pneumonia. From each child, we collected demographic and clinical data, a CXR, and a set of ultrasound images using a Butterfly ultrasound probe. Images were independently interpreted by two radiologists blinded to the results of the other imaging modality. Using CXR as the gold standard, we determined the sensitivity and specificity, positive and negative predictive values, and likelihood ratios for pneumonia using lung POCUS. Results This preliminary analysis included 50 children seen between May-October 2020. Median age (9 months) (Range 4-15). 58% were male, (29/50). Median temperature was 37.3⁰C (range 36.5-38.0); median respiratory and pulse rates were 41 breaths/min (range 31-50) and 139 beats/min (range 124-160) respectively; median SpO2 on RA was 91% (range 89-95). 50% of cases had difficulty breathing (82%, 41/50); chest retractions (70%, 35/50) and grunting (62%, 31/50). Ultrasound images for 49/50 (98%) cases and CXRs for 50/50 (100%) of cases we analyzed. Sensitivity of lung POCUS in the detection of CAP was 61% (95% Cl: 0.52-0.84). The specificity was 77% (95% Cl: 0.56-0.91). Positive predictive value (PPV) 70% (95% CI: 0.62-0.94) and negative predictive value (NPV) 69% (95% CI: 0.56-0.79). Conclusion Preliminary findings of this study demonstrated the lower diagnostic accuracy of lung POCUS versus CXR in the detection of pneumonia in children 1- 59 months. The high specificity of the test will aid in ruling out severe pneumonia in children. Due to its availability, ease of interpretation, and absence of radiation exposure, lung POCUS should still be considered as an important initial imaging tool for the diagnosis of CAP in children in limited-resource settings. Disclosures All Authors: No reported disclosures

scholarly journals Evaluation of the diagnostic accuracy of a new point-of-care rapid test for SARS-CoV-2 virus detection

2020 ◽  
Author(s):  
Leonardo Miscio ◽  
Antonio Olivieri ◽  
Francesco Labonia ◽  
Gianfranco De Feo ◽  
Paolo Chiodini ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Real Time ◽  
Real Time Pcr ◽  
Point Of Care ◽  
Virus Detection ◽  
Rapid Test ◽  
Reference Method ◽  
Standard Of Care ◽  
Easy Access ◽  
Diagnostic Tools

Abstract Background: The easy access to a quick diagnosis of coronavirus disease 2019 (COVID-19) is a key point to improve the management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to contain its spread. Up to now, laboratory real-time PCR is the standard of care, but requires a fully equipped laboratory and significant infrastructure. Consequently, new diagnostic tools are required. Methods: In the present work, the diagnostic accuracy of the point-of-care rapid test "bKIT Virus Finder COVID-19" (Hyris Ltd) is evaluated by a retrospective and a prospective analysis on SARS CoV-2 samples previously assessed with an FDA “authorized for the emergency use - EUA” reference method. Descriptive statistics were used for the present study.Results: Results obtained with the Hyris Kit are the same as that of standard laboratory-based real time PCR methods for all the analyzed samples. In addition, the Hyris Kit provides the test results in less than 2 hours, a significantly shorter time compared to the reference methods, without the need of a fully equipped laboratory. Conclusions: To conclude, the Hyris kit represents a promising tool to improve the health surveillance and to increase the capacity of SARS-CoV-2 testing.

scholarly journals OC 8432 EVALUATION OF AN ANTIBODY-DETECTING POINT-OF-CARE TEST FOR THE DIAGNOSIS OF TAENIA SOLIUM TAENIASIS AND NEUROCYSTICERCOSIS/CYSTICERCOSIS IN AN ENDEMIC AREA

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A6.1-A6
Author(s):  
Chishimba Mubanga ◽  
Kabemba Mwape ◽  
Gideon Zulu ◽  
Isaac Phiri ◽  
Chiara Trevisan ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Point Of Care ◽  
Taenia Solium ◽  
Community Setting ◽  
Diagnostic Value ◽  
Community Level ◽  
Diagnostic Tools ◽  
Successful Implementation ◽  
Index Test ◽  
Endemic Areas

BackgroundTaenia solium taeniasis/(neuro)cysticercosis is a neglected parasitic zoonosis with significant economic and public health impacts. Neurocysticercosis is responsible for 30% cases of acquired epilepsy in endemic areas. Diagnosis and case management of neurocysticercosis/taeniasis in resource-limited endemic countries is challenging. Reliable, inexpensive and easy to use diagnostic tools with sufficient sensitivity and specificity are currently not available. A new point-of-care (POC) test based on recombinant rT24H and rES33 proteins developed by the Centre for Disease Control in Atlanta (US) which combines diagnosis of taeniasis and cysticercosis has been developed, however, its performance at community level is not known. The aim of this study is therefore, to evaluate the diagnostic performance of this test in a community setting.MethodsThe study site is Mtandaza community, Sinda district, Eastern Province of Zambia. The diagnostic accuracy is being evaluated for taeniasis and (neuro) cysticercosis in 1200 randomly selected participants in a community-based study. The performance characteristics (sensitivity and specificity) for neurocysticercosis will be computed by cross-tabulating of POC results with those of the ‘neurocysticercosis diagnosis’ while a Bayesian approach will be used for cysticercosis and taeniasis to compare the performance of the index test with reference tests (enzyme-linked immuno-electrotransfer blot (EITB), B158/B60 Ag-ELISA, Ab-ELISA, Copro-Ag ELISA, PCR).ResultsPreliminary results of 505 POC tests so far conducted show that 0.8% were positive for taeniasis, 9.1% for cysticercosis and, 4.6% were invalid or unclear. Except for Copro-Ag and B158/B60 Ag-ELISA for taeniasis and cysticercosis respectively, reference tests are yet to be conducted.ConclusionResults will show the diagnostic value of the POC test and its applicability for use at community level in endemic areas. If successful, implementation of the tool will enable early detection of taeniasis and suspected neurocysticercosis cases and lead to improved patient management and treatment outcomes.

scholarly journals An evaluation of the SD Bioline HIV/syphilis duo test

2017 ◽  
Vol 29 (1) ◽  
pp. 57-62 ◽  
Author(s):  
Jeffrey Holden ◽  
Joshua Goheen ◽  
Mary Jett-Goheen ◽  
Mathilda Barnes ◽  
Yu-Hsiang Hsieh ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Point Of Care ◽  
Low Cost ◽  
Treponema Pallidum ◽  
Rapid Test ◽  
Health Department ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Screening Algorithm ◽  
Most At Risk Populations

Many health agencies now recommend routine HIV and syphilis testing for pregnant women and most-at-risk populations such as men who have sex with men. With the increased availability of highly sensitive, low cost rapid point-of-care tests, the ability to meet those recommendations has increased, granting wider access to quick and accurate diagnoses. Using blood specimens collected from a Baltimore City Health Department (BCHD) sexually transmitted infection clinic, we evaluated the SD Bioline HIV/Syphilis Duo, a rapid test that simultaneously detects antibodies to HIV and syphilis and has the potential to further benefit clinics and patients by reducing costs, testing complexity, and patient wait times. SD DUO HIV sensitivity and specificity, when compared to BCHD results, were 91.7 and 99.5%, respectively. SD DUO syphilis sensitivity and specificity, when compared to rapid plasma reagin, were 85.7 and 96.8%, respectively, and 69.7 and 99.7%, respectively, when compared to Treponema pallidum particle agglutination (TPPA). SD DUO syphilis sensitivity and specificity, when compared to a traditional screening algorithm, improved to 92.3 and 100%, respectively, and improved to 72.9 and 99.7%, respectively, when compared to a reverse screening algorithm. The HIV component of the SD DUO performed moderately well. However, results for the SD DUO syphilis component, when compared to TPPA, support the need for further testing and assessment.

Live-trapping and bovine tuberculosis testing of free-ranging white-tailed deer for targeted removal

2012 ◽  
Vol 39 (2) ◽  
pp. 104 ◽  
Author(s):  
Melinda K. Cosgrove ◽  
Henry Campa ◽  
Stephen M. Schmitt ◽  
David R. Marks ◽  
Anthony S. Wilson ◽  
...  
Keyword(s):  
Disease Transmission ◽  
Bovine Tuberculosis ◽  
Blood Test ◽  
Bacterial Culture ◽  
Control Strategies ◽  
Rapid Test ◽  
The North ◽  
Live Trapping ◽  
The Cost ◽  
Free Ranging

Context Significant efforts have been made in Michigan, USA, to reduce the prevalence of bovine tuberculosis (TB) in free-ranging white-tailed deer (Odocoileus virginianus) over the past 15 years. Since 2002, however, prevalence has changed little, prompting the need for new control strategies. Aims In January–March of 2007 and 2008, a trap–test–cull project was conducted on an 11 000-ha property in the north-eastern Lower Peninsula of Michigan. The objectives were to assess the feasibility of live-trapping and testing white-tailed deer for TB as a means for targeted removal and estimate the cost of this effort. Methods Live-trapped deer were ear-tagged and a blood sample was drawn for use with the CervidTB STAT-PAK (commonly called Rapid Test) for TB diagnosis in the field. Deer testing negative were released, whereas deer testing positive were euthanised to confirm blood-test results via bacterial culture. Key results In all, 762 (741 with known sex and age) individual deer were captured and tested for TB. Adults comprised 59% (437 of 741) of the captures. Eight (1.8%) adults were positive on the blood test; six of eight (1.4% of adults) were confirmed TB positive via bacterial culture. Estimated TB prevalence in the present study was 2.5% (adjusted for Rapid Test sensitivity of 56%), being lower than what would be expected on the basis of routine hunter-harvest surveillance for this site which has yielded prevalence rates from 3.4% to 4.8%. Results demonstrated the ability to trap and test a substantial number of deer given high deer densities (16–20 deer per km2), availability of traps and abundant workers. The 2-year project cost a total of ~US$228 000, or US$38 000 per culture-positive animal. Conclusions Because of the cost and effort involved, a project such as the present one applied to Michigan’s larger TB-management area (148 018 ha) is not feasible. Implications If the efficiency and effectiveness of a trap–test–cull project could be improved by vaccinating test-negative animals, should a vaccine be approved for use in free-ranging white-tailed deer, a trap–test–cull project applied on a scale similar to the present study may prove beneficial by possibly reducing disease transmission, in addition to removing TB-positive animals.

scholarly journals Multi-laboratory evaluation of ReaScan TBE IgM rapid test, 2016 to 2017

2020 ◽  
Vol 25 (12) ◽  
Author(s):  
Bo Albinsson ◽  
Anu E. Jääskeläinen ◽  
Kairi Värv ◽  
Mateja Jelovšek ◽  
Corine GeurtsvanKessel ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Rapid Test ◽  
Health Concern ◽  
Laboratory Evaluation ◽  
Serum Samples ◽  
Barr Virus ◽  
Tbe Virus ◽  
Epstein Barr

Background Tick-borne encephalitis (TBE) is a potentially severe neurological disease caused by TBE virus (TBEV). In Europe and Asia, TBEV infection has become a growing public health concern and requires fast and specific detection. Aim In this observational study, we evaluated a rapid TBE IgM test, ReaScan TBE, for usage in a clinical laboratory setting. Methods Patient sera found negative or positive for TBEV by serological and/or molecular methods in diagnostic laboratories of five European countries endemic for TBEV (Estonia, Finland, Slovenia, the Netherlands and Sweden) were used to assess the sensitivity and specificity of the test. The patients’ diagnoses were based on other commercial or quality assured in-house assays, i.e. each laboratory’s conventional routine methods. For specificity analysis, serum samples from patients with infections known to cause problems in serology were employed. These samples tested positive for e.g. Epstein–Barr virus, cytomegalovirus and Anaplasma phagocytophilum, or for flaviviruses other than TBEV, i.e. dengue, Japanese encephalitis, West Nile and Zika viruses. Samples from individuals vaccinated against flaviviruses other than TBEV were also included. Altogether, 172 serum samples from patients with acute TBE and 306 TBE IgM negative samples were analysed. Results Compared with each laboratory’s conventional methods, the tested assay had similar sensitivity and specificity (99.4% and 97.7%, respectively). Samples containing potentially interfering antibodies did not cause specificity problems. Conclusion Regarding diagnosis of acute TBEV infections, ReaScan TBE offers rapid and convenient complementary IgM detection. If used as a stand-alone, it can provide preliminary results in a laboratory or point of care setting.

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