scholarly journals Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

2015 ◽  
Vol 54 (2) ◽  
pp. 492-494 ◽  
Author(s):  
S. R. Leon ◽  
L. B. Ramos ◽  
S. K. Vargas ◽  
N. Kojima ◽  
D. G. Perez ◽  
...  
Keyword(s):  
Point Of Care ◽  
Treponema Pallidum ◽  
Antibody Detection ◽  
Laboratory Evaluation ◽  
Laboratory Performance ◽  
Content Type ◽  
Test Sensitivity ◽  
Syphilis Testing

We assessed the laboratory performance of the Chembio dual-path platform HIV-syphilis rapid immunodiagnostic test and electronic reader for detection of HIV andTreponema pallidumantibodies in 450 previously characterized serum specimens. For visual or electronic reader HIV antibody detection, the sensitivity was 100% and the specificity was 98.7%. For visualT. pallidumantibody detection, the test sensitivity was 94.7% and the specificity was 100.0%; with the electronic reader, the sensitivity was 94.7% and the specificity was 99.7%.

scholarly journals Laboratory Evaluation of a Point-of-Care Downward-Flow Assay for Simultaneous Detection of Antibodies to Treponema pallidum and Human Immunodeficiency Virus

2016 ◽  
Vol 54 (7) ◽  
pp. 1922-1924 ◽  
Author(s):  
S. Herbst de Cortina ◽  
C. C. Bristow ◽  
S. K. Vargas ◽  
D. G. Perez ◽  
K. A. Konda ◽  
...  
Keyword(s):  
Point Of Care ◽  
Simultaneous Detection ◽  
Treponema Pallidum ◽  
Antibody Detection ◽  
Laboratory Evaluation ◽  
Serum Samples ◽  
Downward Flow ◽  
Content Type ◽  
Screening Programs ◽  
Point Of Care Test

Combining the detection of syphilis and HIV antibodies into one point-of-care test integrates syphilis screening into already existing HIV screening programs, which may be particularly beneficial in settings such as antenatal care. Using the INSTI Multiplex downward-flow immunoassay, we tested 200 stored serum samples from high-risk patients enrolled in a longitudinal study on HIV infection and syphilis in Peruvian men who have sex with men and transgender women. This rapid assay detected HIV andTreponema pallidumserum antibodies with sensitivities of 100% (95% confidence interval [CI], 95.9% to 100%) and 87.4% (95% CI, 81.4% to 92.0%), respectively, and specificities of 95.5% (95% CI, 89.9% to 98.5%) and 97.0% (95% CI, 84.2% to 99.9%), respectively (n= 200). The sensitivity for syphilis antibody detection was higher in patients with a rapid plasma reagin titer of ≥1:8 (97.3%) than in those with a titer of ≤1:4 (90%) or a nonreactive titer (66.7%).

scholarly journals Evaluation of the Lumipulse G TP-N Chemiluminescent Immunoassay as a Syphilis Screening Test

2017 ◽  
Vol 55 (11) ◽  
pp. 3236-3241 ◽  
Author(s):  
Daniel A. Ortiz ◽  
Michael J. Loeffelholz
Keyword(s):  
Treponema Pallidum ◽  
High Volume ◽  
Performance Characteristics ◽  
Automated System ◽  
Antibody Detection ◽  
Labor Costs ◽  
Content Type ◽  
Percent Agreement ◽  
Syphilis Screening ◽  
Chemiluminescent Immunoassay

ABSTRACTA syphilis diagnosis is often aided by the detection of treponemal and nontreponemal antibodies. Automated treponemal antibody detection systems enable high-volume clinical laboratories to perform syphilis screening at a faster pace with lower labor costs. The Lumipulse G TP-N chemiluminescent immunoassay is an automated system that qualitatively detects IgG and IgM antibodies againstTreponema pallidumantigens in human serum and plasma. To assess performance characteristics and workflow efficiency, the Lumipulse G TP-N assay was compared to the Bioplex 2200 Syphilis IgG multiplex flow immunoassay. Among the 4,134 routine and HIV samples tested by the two automated assays, the percentage of agreement was excellent at 99.0% (95% confidence interval [CI], 98.6% to 99.2%; κ, 0.89), with the Lumipulse G TP-N having a shorter time to first and subsequent results. All specimens with reactive syphilis screening results were further tested by rapid plasma reagin (RPR) andTreponema pallidumparticle agglutination (TP·PA) testing (n= 231). The results from the RPR-reactive samples (n= 82) showed complete concordance with the two automated assays, while the TP·PA assay displayed some discrepancies. The positive percent agreement (PPA) and negative percent agreement (NPA) between the TP·PA test and the Lumipulse G TP-N test were 98.9% and 77.3%, respectively. The Bioplex 2200 Syphilis IgG immunoassay displayed a similar PPA (100%) but a substantially lower NPA (15.9%). Patient chart reviews of discrepant results suggested that the Lumipulse G TP-N assay produced 27 fewer falsely reactive results and can reduce the amount of additional confirmatory RPR and TP·PA testing needed. The analogous performance characteristics of the two automated systems indicate that the Lumipulse G TP-N assay is suitable for high-throughput syphilis screening.

scholarly journals Engineering luminescent biosensors for point-of-care SARS-CoV-2 antibody detection

2021 ◽  
Author(s):  
Susanna K. Elledge ◽  
Xin X. Zhou ◽  
James R. Byrnes ◽  
Alexander J. Martinko ◽  
Irene Lui ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antibody Detection

scholarly journals Recent advances and novel approaches in laboratory-based diagnostic mycology

2019 ◽  
Vol 57 (Supplement_3) ◽  
pp. S259-S266 ◽  
Author(s):  
P Lewis White
Keyword(s):  
Point Of Care ◽  
Antibody Detection ◽  
Molecular Testing ◽  
Point Of Care Testing ◽  
Proximity Ligation ◽  
Molecular Assays ◽  
Lateral Flow Assays ◽  
Novel Approaches ◽  
Exciting Time ◽  
Generation Sequencing

Abstract The field of diagnostic mycology represents much more than culture and microscopy and is rapidly embracing novel techniques and strategies to help overcome the limitations of conventional approaches. Commercial molecular assays increase the applicability of PCR testing and may identify markers of antifungal resistance, which are of great clinical concern. Lateral flow assays simplify testing and turn-around time, with potential for point of care testing, while proximity ligation assays embrace the sensitivity of molecular testing with the specificity of antibody detection. The first evidence of patient risk stratification is being described and together with the era of next generation sequencing represents an exciting time in mycology.

scholarly journals Help in the Choice of Automated or Semiautomated Immunoassays for Serological Diagnosis of Toxoplasmosis: Evaluation of Nine Immunoassays by the French National Reference Center for Toxoplasmosis

2016 ◽  
Vol 54 (12) ◽  
pp. 3034-3042 ◽  
Author(s):  
O. Villard ◽  
B. Cimon ◽  
C. L'Ollivier ◽  
H. Fricker-Hidalgo ◽  
N. Godineau ◽  
...  
Keyword(s):  
Congenital Toxoplasmosis ◽  
Antibody Detection ◽  
Clinical Settings ◽  
Serum Samples ◽  
Igg Antibody ◽  
Routine Testing ◽  
Content Type ◽  
Specificity And Sensitivity ◽  
National Reference Center ◽  
Serology Testing

Toxoplasmosis, a benign infection, is asymptomatic or paucisymptomatic in over 80% of cases, except in immunocompetent patients suffering from ocular toxoplasmosis or in immunocompromised patients with opportunistic or congenital toxoplasmosis. Diagnosis is based mainly on serology testing. Thus, we compared the performance of the nine most commonly used commercial automated or semiautomated immunoassays for IgG and IgMToxoplasma gondiiantibody detection, that is, the Advia Centaur, Architect, AxSYM, Elecsys, Enzygnost, Liaison, Platelia, VIDAS, and VIDIA assays. The assays were conducted on four panels of serum samples derived during routine testing from patients with an interfering disease and who exhibited a low IgG antibody level in one of two clinical settings, namely, acute or chronic toxoplasmosis. As a result, IgG sensitivities ranged from 97.1% to 100%, and IgG specificities ranged from 99.5% to 100%. For IgG quantification, strong differences in IgG titers (expressed in IU/ml) were noted depending on the assay used. IgM sensitivities ranged from 65% to 97.9%, and IgM specificities ranged from 92.6% to 100%. For defining the best serological strategies to be implemented, it appears crucial to compare the diagnostic performance of the different tests with respect to their specificity and sensitivity in detecting the presence of IgG and IgM antibodies.

scholarly journals Context-Specific Procedures for the Diagnosis of Human Schistosomiasis – A Mini Review

2021 ◽  
Vol 2 ◽  
Author(s):  
Pytsje T. Hoekstra ◽  
Govert J. van Dam ◽  
Lisette van Lieshout
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Public Health Problem ◽  
Nucleic Acid Amplification ◽  
Antibody Detection ◽  
Infection Model ◽  
Related Factors ◽  
Human Schistosomiasis ◽  
Diagnostic Approaches ◽  
Context Specific

Schistosomiasis is a parasitic disease caused by trematode blood flukes of the genus Schistosoma, affecting over 250 million people mainly in the tropics. Clinically, the disease can present itself with acute symptoms, a stage which is relatively more common in naive travellers originating from non-endemic regions. It can also develop into chronic disease, with the outcome depending on the Schistosoma species involved, the duration and intensity of infection and several host-related factors. A range of diagnostic tests is available to determine Schistosoma infection, including microscopy, antibody detection, antigen detection using the Point-Of-Care Circulating Cathodic Antigen (POC-CCA) test and the Up-Converting Particle Lateral Flow Circulating Anodic Antigen (UCP-LF CAA) test, as well as Nucleic Acid Amplification Tests (NAATs) such as real-time PCR. In this mini review, we discuss these different diagnostic procedures and explore their most appropriate use in context-specific settings. With regard to endemic settings, diagnostic approaches are described based on their suitability for individual diagnosis, monitoring control programs, determining elimination as a public health problem and eventual interruption of transmission. For non-endemic settings, we summarize the most suitable diagnostic approaches for imported cases, either acute or chronic. Additionally, diagnostic options for disease-specific clinical presentations such as genital schistosomiasis and neuro-schistosomiasis are included. Finally, the specific role of diagnostic tests within research settings is described, including a controlled human schistosomiasis infection model and several clinical studies. In conclusion, context-specific settings have different requirements for a diagnostic test, stressing the importance of a well-considered decision of the most suitable diagnostic procedure.

scholarly journals A Rapid Immunochromatography Test Based on Hcp1 Is a Potential Point-of-Care Test for Serological Diagnosis of Melioidosis

2018 ◽  
Vol 56 (8) ◽  
Author(s):  
Phornpun Phokrai ◽  
Wisansanee Karoonboonyanan ◽  
Nida Thanapattarapairoj ◽  
Chidchanok Promkong ◽  
Adul Dulsuk ◽  
...  
Keyword(s):  
Point Of Care ◽  
Clinical Manifestations ◽  
Antibody Detection ◽  
Enzyme Linked Immunosorbent Assay ◽  
Target Antigen ◽  
Northeast Thailand ◽  
Serum Samples ◽  
Serological Method ◽  
Healthy Donors ◽  
Wide Range

ABSTRACTMelioidosis is a fatal infectious disease caused by the environmental bacteriumBurkholderia pseudomallei. It is highly endemic in Asia and northern Australia but neglected in many other tropical countries. Melioidosis patients have a wide range of clinical manifestations, and definitive diagnosis requires bacterial culture, which can be time-consuming. A reliable rapid serological tool is greatly needed for disease surveillance and diagnosis. We previously demonstrated by enzyme-linked immunosorbent assay (ELISA) that a hemolysin-coregulated protein (Hcp1) is a promising target for serodiagnosis of melioidosis. In this study, we developed a rapid immunochromatography test (ICT) using Hcp1 as the target antigen (Hcp1-ICT). We evaluated this test for specific antibody detection using serum samples obtained from 4 groups of human subjects, including the following: (i) 487 culture-confirmed melioidosis patients from four hospitals in northeast Thailand; (ii) 202 healthy donors from northeast Thailand; (iii) 90 U.S. healthy donors; and (iv) 207 patients infected with other organisms. Compared to culture results as a gold standard, the sensitivity of ICT for all hospitals was 88.3%. The specificities for Thai donors and U.S. donors were 86.1% and 100%, respectively, and the specificity for other infections was 91.8%. The results of the Hcp1-ICT demonstrated 92.4% agreement with the Hcp1-ELISA results with a kappa value of 0.829, indicating that the method is much improved compared with the current serological method, the indirect hemagglutination assay (IHA) (69.5% sensitivity and 67.6% specificity for Thais). The Hcp1-ICT represents a potential point-of-care (POC) test and may be used to replace the IHA for screening of melioidosis in hospitals as well as in resource-limited areas.

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