Cargando…
Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges
BACKGROUND: The cost of conventional serological testing for toxoplasmosis discourages universal adoption of prenatal monthly screening programs to prevent congenital toxoplasmosis. Point-of-care (POC) technology may constitute a cost-effective approach. METHODS: We evaluated the diagnostic accuracy...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204989/ https://www.ncbi.nlm.nih.gov/pubmed/30393749 http://dx.doi.org/10.1093/ofid/ofy215 |
_version_ | 1783366125163118592 |
---|---|
author | Gomez, Carlos A Budvytyte, Laura N Press, Cindy Zhou, Lily McLeod, Rima Maldonado, Yvonne Montoya, Jose G Contopoulos-Ioannidis, Despina G |
author_facet | Gomez, Carlos A Budvytyte, Laura N Press, Cindy Zhou, Lily McLeod, Rima Maldonado, Yvonne Montoya, Jose G Contopoulos-Ioannidis, Despina G |
author_sort | Gomez, Carlos A |
collection | PubMed |
description | BACKGROUND: The cost of conventional serological testing for toxoplasmosis discourages universal adoption of prenatal monthly screening programs to prevent congenital toxoplasmosis. Point-of-care (POC) technology may constitute a cost-effective approach. METHODS: We evaluated the diagnostic accuracy of 3 Toxoplasma POC tests against gold-standard testing performed at Palo Alto Medical Foundation Toxoplasma Serology Laboratory (PAMF-TSL). The POC tests included the following: Toxo IgG/IgM Rapid Test (Biopanda) and the OnSite Toxo IgG/IgM Combo-Rapid-test that detect IgG and IgM separately, and the Toxoplasma ICT-IgG-IgM-bk (LDBIO) that detects either or both immunoglobulin IgG/IgM in combination. Samples were selected from PAMF-TSL biobank (n = 210) and Centers for Disease Control and Prevention Toxoplasma 1998 Human Serum Panel (n = 100). Based on PAMF-TSL testing, Toxoplasma-infection status was classified in 4 categories: acute infections (n = 85), chronic infections (n = 85), false-positive Toxoplasma IgM (n = 60), and seronegative (n = 80). The POC testing was performed in duplicate following manufacturer’s instructions by investigators blinded to PAMF-TSL results. Sensitivity and specificity were calculated. RESULTS: A total of 1860 POC tests were performed. For detection of Toxoplasma IgG, sensitivity was 100% (170 of 170; 95% confidence interval [CI], 97.8%–100%) for all 3 POC kits; specificity was also comparable at 96.3% (77 of 80; 95% CI, 89.5%–98.9%), 97.5% (78 of 80; 95% CI, 91.3%–99.6%), and 98.8% (79 of 80; 95% CI, 93.2%–99.9%). However, sensitivity for detection of Toxoplasma IgM varied significantly across POC tests: Biopanda, 62.2% (51 of 82; 95% CI, 51.4%–71.9%); OnSite, 28% (23 of 82; 95% CI, 19.5%–38.6%); and LDBIO combined IgG/IgM, 100% (82 of 82; 95% CI, 95.5%–100%). Diagnostic accuracy was significantly higher for the LDBIO POC kit. The POC kits did not exhibit cross-reactivity for false-positive Toxoplasma-IgM sera. CONCLUSIONS: The 3 evaluated POC kits revealed optimal sensitivity for Toxoplasma-IgG antibodies. The LDBIO-POC test exhibited 100% sensitivity for the combined detection of IgG/IgM in acute and chronic Toxoplasma infection. Biopanda and Onsite POC tests exhibited poor sensitivity for Toxoplasma-IgM detection. |
format | Online Article Text |
id | pubmed-6204989 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-62049892018-11-02 Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges Gomez, Carlos A Budvytyte, Laura N Press, Cindy Zhou, Lily McLeod, Rima Maldonado, Yvonne Montoya, Jose G Contopoulos-Ioannidis, Despina G Open Forum Infect Dis Major Article BACKGROUND: The cost of conventional serological testing for toxoplasmosis discourages universal adoption of prenatal monthly screening programs to prevent congenital toxoplasmosis. Point-of-care (POC) technology may constitute a cost-effective approach. METHODS: We evaluated the diagnostic accuracy of 3 Toxoplasma POC tests against gold-standard testing performed at Palo Alto Medical Foundation Toxoplasma Serology Laboratory (PAMF-TSL). The POC tests included the following: Toxo IgG/IgM Rapid Test (Biopanda) and the OnSite Toxo IgG/IgM Combo-Rapid-test that detect IgG and IgM separately, and the Toxoplasma ICT-IgG-IgM-bk (LDBIO) that detects either or both immunoglobulin IgG/IgM in combination. Samples were selected from PAMF-TSL biobank (n = 210) and Centers for Disease Control and Prevention Toxoplasma 1998 Human Serum Panel (n = 100). Based on PAMF-TSL testing, Toxoplasma-infection status was classified in 4 categories: acute infections (n = 85), chronic infections (n = 85), false-positive Toxoplasma IgM (n = 60), and seronegative (n = 80). The POC testing was performed in duplicate following manufacturer’s instructions by investigators blinded to PAMF-TSL results. Sensitivity and specificity were calculated. RESULTS: A total of 1860 POC tests were performed. For detection of Toxoplasma IgG, sensitivity was 100% (170 of 170; 95% confidence interval [CI], 97.8%–100%) for all 3 POC kits; specificity was also comparable at 96.3% (77 of 80; 95% CI, 89.5%–98.9%), 97.5% (78 of 80; 95% CI, 91.3%–99.6%), and 98.8% (79 of 80; 95% CI, 93.2%–99.9%). However, sensitivity for detection of Toxoplasma IgM varied significantly across POC tests: Biopanda, 62.2% (51 of 82; 95% CI, 51.4%–71.9%); OnSite, 28% (23 of 82; 95% CI, 19.5%–38.6%); and LDBIO combined IgG/IgM, 100% (82 of 82; 95% CI, 95.5%–100%). Diagnostic accuracy was significantly higher for the LDBIO POC kit. The POC kits did not exhibit cross-reactivity for false-positive Toxoplasma-IgM sera. CONCLUSIONS: The 3 evaluated POC kits revealed optimal sensitivity for Toxoplasma-IgG antibodies. The LDBIO-POC test exhibited 100% sensitivity for the combined detection of IgG/IgM in acute and chronic Toxoplasma infection. Biopanda and Onsite POC tests exhibited poor sensitivity for Toxoplasma-IgM detection. Oxford University Press 2018-10-29 /pmc/articles/PMC6204989/ /pubmed/30393749 http://dx.doi.org/10.1093/ofid/ofy215 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Major Article Gomez, Carlos A Budvytyte, Laura N Press, Cindy Zhou, Lily McLeod, Rima Maldonado, Yvonne Montoya, Jose G Contopoulos-Ioannidis, Despina G Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges |
title | Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges |
title_full | Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges |
title_fullStr | Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges |
title_full_unstemmed | Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges |
title_short | Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges |
title_sort | evaluation of three point-of-care tests for detection of toxoplasma immunoglobulin igg and igm in the united states: proof of concept and challenges |
topic | Major Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204989/ https://www.ncbi.nlm.nih.gov/pubmed/30393749 http://dx.doi.org/10.1093/ofid/ofy215 |
work_keys_str_mv | AT gomezcarlosa evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT budvytytelauran evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT presscindy evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT zhoulily evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT mcleodrima evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT maldonadoyvonne evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT montoyajoseg evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges AT contopoulosioannidisdespinag evaluationofthreepointofcaretestsfordetectionoftoxoplasmaimmunoglobuliniggandigmintheunitedstatesproofofconceptandchallenges |