Comparison of Two Commercial ELISA Kits for the Detection of Anti-Dengue IgM for Routine Dengue Diagnosis in Laos
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Patients
2.3. Ethics Statement
2.4. Sample Selection
2.4.1. Panel A
2.4.2. Panel B
2.5. Anti-Dengue IgM ELISAs
2.6. Statistical Analysis
3. Results
3.1. Panel A
3.2. Panel B
4. Discussion
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
- WHO. Dengue and Severe Dengue. Available online: http://www.who.int/mediacentre/factsheets/fs117/en/ (accessed on 25 December 2016).
- Bhatt, S.; Gething, P.W.; Brady, O.J.; Messina, J.P.; Farlow, A.W.; Moyes, C.L.; Drake, J.M.; Brownstein, J.S.; Hoen, A.G.; Sankoh, O.; et al. The global distribution and burden of dengue. Nature 2013, 496, 504–507. [Google Scholar] [CrossRef] [PubMed]
- Peeling, R.W.; Artsob, H.; Pelegrino, J.L.; Buchy, P.; Cardosa, M.J.; Devi, S.; Enria, D.; Farrar, J.; Gubler, D.J.; Guzman, M.G.; et al. Evaluation of diagnostic tests: Dengue. Nat. Rev. Microbiol. 2010, 8, S30–S37. [Google Scholar] [CrossRef] [PubMed]
- WHO. Handbook for Clinical Management of Dengue. Available online: http://www.who.int/denguecontrol/9789241504713/en/ (accessed on 1 January 2017).
- World Health Organization. Comprehensive Guidelines for Prevention and Control of Dengue and Dengue Haemorrhagic Fever, Rev. and Expanded ed.; World Health Organization Regional Office for South-East Asia: New Delhi, India, 2011. [Google Scholar]
- Gubler, D.J. Dengue and Dengue Hemorrhagic Fever. Clin. Microbiol. Rev. 1998, 11, 480–496. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- World Health Organization. Dengue: Guidelines for Diagnosis, Treatment, Prevention, and Control, New ed.; World Health Organization TDR: Geneva, Switzerland, 2009. [Google Scholar]
- Blacksell, S.D.; Jarman, R.G.; Gibbons, R.V.; Tanganuchitcharnchai, A.; Mammen, M.P.; Nisalak, A.; Kalayanarooj, S.; Bailey, M.S.; Premaratna, R.; De Silva, H.J.; et al. Comparison of Seven Commercial Antigen and Antibody Enzyme-Linked Immunosorbent Assays for Detection of Acute Dengue Infection. Clin. Vaccine Immunol. 2012, 19, 804–810. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Groen, J.; Koraka, P.; Velzing, J.; Copra, C.; Osterhaus, A.D. Evaluation of six immunoassays for detection of dengue virus-specific immunoglobulin M and G antibodies. Clin. Diagn. Lab. Immunol. 2000, 7, 867–871. [Google Scholar] [CrossRef] [PubMed]
- Vazquez, S.; Hafner, G.; Ruiz, D.; Calzada, N.; Guzman, M.G. Evaluation of immunoglobulin M and G capture enzyme-linked immunosorbent assay Panbio kits for diagnostic dengue infections. J. Clin. Virol. 2007, 39, 194–198. [Google Scholar] [CrossRef] [PubMed]
- Pal, S.; Dauner, A.L.; Valks, A.; Forshey, B.M.; Long, K.C.; Thaisomboonsuk, B.; Sierra, G.; Picos, V.; Talmage, S.; Morrison, A.C.; et al. Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever. J. Clin. Microbiol. 2015, 53, 1092–1102. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Welch, R.J.; Chang, G.-J.J.; Litwin, C.M. Comparison of a commercial dengue IgM capture ELISA with dengue antigen focus reduction microneutralization test and the centers for disease control dengue IgM capture-ELISA. J. Virol. Methods 2014, 195, 247–249. [Google Scholar] [CrossRef] [PubMed]
- Namekar, M.; Ellis, E.M.; O’Connell, M.; Elm, J.; Gurary, A.; Park, S.Y.; Imrie, A.; Nerurkar, V.R. Evaluation of a New Commercially Available Immunoglobulin M Capture Enzyme-Linked Immunosorbent Assay for Diagnosis of Dengue Virus Infection. J. Clin. Microbiol. 2013, 51, 3102–3106. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- World Health Organization. Dengue Haemorrhagic Fever: Diagnosis, Treatment, Prevention and Control, 2nd ed.; World Health Organization: Geneva, Switzerland, 1997. [Google Scholar]
- Leparc-Goffart, I.; Baragatti, M.; Temmam, S.; Tuiskunen, A.; Moureau, G.; Charrel, R.; De Lamballerie, X. Development and validation of real-time one-step reverse transcription-PCR for the detection and typing of dengue viruses. J. Clin. Virol. 2009, 45, 61–66. [Google Scholar] [CrossRef] [PubMed]
- Slack, A.; Symonds, M.; Dohnt, M.; Harris, C.; Brookes, D.; Smythe, L. Evaluation of a modified Taqman assay detecting pathogenic Leptospira spp. against culture and Leptospira-specific IgM enzyme-linked immunosorbent assay in a clinical environment. Diagn. Microbiol. Infect. Dis. 2007, 57, 361–366. [Google Scholar] [CrossRef] [PubMed]
- Smythe, L.D.; Smith, I.L.; Smith, A.G.; Dohnt, M.F.; Symonds, M.L.; Barnett, L.J.; McKay, D.B. A quantitative PCR (TaqMan) assay for pathogenic Leptospira spp. BMC Infect. Dis. 2002, 2, 13. [Google Scholar] [CrossRef]
- Thaipadunpanit, J.; Chierakul, W.; Wuthiekanun, V.; Limmathurotsakul, D.; Amornchai, P.; Boonslip, S.; Smythe, L.D.; Limpaiboon, R.; Hoffmaster, A.R.; Day, N.P.; et al. Diagnostic accuracy of real-time PCR assays targeting 16S rRNA and lipL32 genes for human leptospirosis in Thailand: A case-control study. PLoS ONE 2011, 6, e16236. [Google Scholar] [CrossRef] [PubMed]
- Jiang, J.; Dasch, G.A.; Ching, W.-M.; Richards, A.L.; Chan, T.-C.; Temenak, J.J. Development of a quantitative real-time polymerase chain reaction assay specific for orientia tsutsugamushi. Am. J. Trop. Med. Hyg. 2004, 70, 351–356. [Google Scholar] [CrossRef] [PubMed]
- Parikh, R.; Mathai, A.; Parikh, S.; Sekhar, G.C.; Thomas, R. Understanding and using sensitivity, specificity and predictive values. Indian J. Ophthalmol. 2008, 56, 45–50. [Google Scholar] [CrossRef] [PubMed]
- FDA. Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests. 2007. Available online: http://www.fda.gov/RegulatoryInformation/Guidances/ucm071148.htm (accessed on 22 January 2017).
- Landis, J.R.; Koch, G.G. The Measurement of Observer Agreement for Categorical Data. Biometrics 1977, 33, 159–174. [Google Scholar] [CrossRef] [PubMed]
- R Core Team. R: A Language and Environment for Statistical Computing; R Foundation for Statistical Computing: Vienna, Austria, 2015; Available online: https://www.R-project.org/ (accessed on 1 December 2016).
- Vaughn, D.W.; Green, S.; Kalayanarooj, S.; Innis, B.L.; Nimmannitya, S.; Suntayakorn, S.; Rothman, A.L.; Ennis, F.A.; Nisalak, A. Dengue in the early febrile phase: Viremia and antibody responses. J. Infect. Dis. 1997, 176, 322–330. [Google Scholar] [CrossRef] [PubMed]
- Acestor, A.; Cooksey, R.; Newton, P.N.; Ménard, D.; Guerin, P.J.; Nakagawa, J.; Christophel, E.; González, I.J.; Bell, D. Mapping the aetio logy of non-malarial febrile illness in SE Asia—Terra incognita impairing empirical treatment policies. PLoS ONE 2012, 7, e44269. [Google Scholar] [CrossRef] [PubMed]
Patient Status (based on Corresponding PCR Results) | n | Days of Fever on Admission, Median (IQR) | Days between Admission and Convalescence, Median (IQR) | |
---|---|---|---|---|
Dengue infection | Dengue | 54 | 5 (4–6) | 12 (9–14) |
Non-dengue infection | Leptospira spp. | 4 | 5 (2.75–7.5) | 2.5 (1.75–4.25) |
O. tsutsugamushi | 5 | 7 (5–8) | 3 (2.75–3.25) | |
Rickettsia spp. | 2 | 7 (7–10) | 8 (7.5–8.5) | |
Total | 65 | 5 (4–6) | 11 (6–14) |
Admission Serum | Convalescent Serum | Combined Sera Result | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dengue Status | Total | Diagnostic Accuracy, % (95% CI) | Dengue Status | Total | Diagnostic Accuracy, % (95% CI) | Dengue Status | Total | Diagnostic Accuracy, % (95% CI) | |||||
Positive | Negative | Positive | Negative | Positive | Negative | ||||||||
Sen: 64.8 (50.6–77.3) | Sen: 77.8 (64.4–87.9) | Sen: 87.0 (75.1–94.6) | |||||||||||
Panbio kit | Positive | 35 | 0 | 35 | Spe: 100 (71.5–100) | 39 | 3 | 42 | Spe: 72.7 (39–93.9) | 47 | 3 | 50 | Spe: 72.7 (39–93.9) |
Negative | 19 | 11 | 30 | PPV: 100 (89.9–100) | 15 | 8 | 23 | PPV: 93.3 (81.7–98.6) | 7 | 8 | 15 | PPV: 94 (83.5–98.7) | |
Total | 54 | 11 | 65 | NPV: 36.7 (19.9–56.1) | 54 | 11 | 65 | NPV: 40.0 (19.1–63.9) | 54 | 11 | 65 | NPV: 53.3 (26.6–78.7) |
Admission Serum | Convalescent Serum | Combined Sera Result | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dengue Status | Total | Diagnostic Accuracy, % (95% CI) | Dengue Status | Total | Diagnostic Accuracy, % (95% CI) | Dengue Status | Total | Diagnostic Accuracy, % (95% CI) | |||||
Positive | Negative | Positive | Negative | Positive | Negative | ||||||||
Sen: 18.5 (9.2–31.4) | Sen: 72.2 (58.4–83.5) | Sen: 72.2 (58.4–83.5) | |||||||||||
InBios kit | Positive | 10 | 0 | 10 | Spe: 100 (71.5–100) | 39 | 0 | 39 | Spe: 100 (71.5–100) | 39 | 0 | 39 | Spe: 100 (71.5–100) |
Negative | 44 * | 11 | 55 | PPV: 100 (69.2–100) | 15 * | 11 | 26 | PPV: 100 (91–100) | 15 | 11 | 26 | PPV: 100 (91–100) | |
Total | 54 | 11 | 65 | NPV: 20 (10.4–33) | 54 | 11 | 65 | NPV: 42.3 (23.4–63.1) | 54 | 11 | 65 | NPV: 42.3 (23.4–63.1) |
Admission Serum | |||||
---|---|---|---|---|---|
Panbio kit | Percent Agreement, % (95% CI) | ||||
Positive | Negative | Total | |||
InBios kit | Positive | 5 | 4 | 9 | Positive: 31.3 (11.0–58.7) |
Negative | 11 | 54 | 65 | Negative: 93.1 (83.3–98.1) | |
Total | 16 | 58 | 74 | overall: 79.7 (68.9–88.2) | |
Cohen’s kappa index (k) = 0.29 (0.025–0.55) | |||||
Convalescent serum | |||||
Panbio kit | Percent Agreement, % (95% CI) | ||||
Positive | Negative | Total | |||
InBios kit | Positive | 8 | 0 | 8 | Positive: 53.3 (26.6–78.7) |
Negative | 7 | 59 | 66 | Negative: 100 (93.9–100) | |
Total | 15 | 59 | 74 | overall: 90.5 (81.5–96.1) | |
Cohen’s kappa index (k) = 0.65 (0.41–0.88) | |||||
Combined admission and convalescent results | |||||
Panbio kit | Percent Agreement, % (95% CI) | ||||
Positive | Negative | Total | |||
InBios kit | Positive | 10 | 2 | 12 | Positive: 47.6 (25.7–70.2) |
Negative | 11 | 51 | 62 | Negative: 96.2 (87.0–99.5) | |
Total | 21 | 53 | 74 | overall: 82.4 (71.8–90.3) | |
Cohen’s kappa index (k) = 0.5 (0.28–0.73) |
© 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
Lu, Y.; Sengvilaipaseuth, O.; Chanthongthip, A.; Phonemixay, O.; Vongsouvath, M.; Phouminh, P.; Blacksell, S.D.; Newton, P.N.; Dubot-Pérès, A. Comparison of Two Commercial ELISA Kits for the Detection of Anti-Dengue IgM for Routine Dengue Diagnosis in Laos. Trop. Med. Infect. Dis. 2019, 4, 111. https://doi.org/10.3390/tropicalmed4030111
Lu Y, Sengvilaipaseuth O, Chanthongthip A, Phonemixay O, Vongsouvath M, Phouminh P, Blacksell SD, Newton PN, Dubot-Pérès A. Comparison of Two Commercial ELISA Kits for the Detection of Anti-Dengue IgM for Routine Dengue Diagnosis in Laos. Tropical Medicine and Infectious Disease. 2019; 4(3):111. https://doi.org/10.3390/tropicalmed4030111
Chicago/Turabian StyleLu, Yixiao, Onanong Sengvilaipaseuth, Anisone Chanthongthip, Ooyanong Phonemixay, Manivanh Vongsouvath, Phonelavanh Phouminh, Stuart D. Blacksell, Paul N. Newton, and Audrey Dubot-Pérès. 2019. "Comparison of Two Commercial ELISA Kits for the Detection of Anti-Dengue IgM for Routine Dengue Diagnosis in Laos" Tropical Medicine and Infectious Disease 4, no. 3: 111. https://doi.org/10.3390/tropicalmed4030111