The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection.
BACKGROUND: The serological diagnosis of acute dengue virus infection relies on the detection of dengue-specific immunoglobulin M (IgM) antibodies. Immunochromatographic tests are rapid diagnostic tests (RDTs) that can be performed at the bedside, but they have not been fully validated for diagnosi...
| Main Authors: | , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
2006
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| _version_ | 1826305041708875776 |
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| author | Blacksell, S Newton, P Bell, D Kelley, J Mammen, M Vaughn, D Wuthiekanun, V Sungkakum, A Nisalak, A Day, N |
| author_facet | Blacksell, S Newton, P Bell, D Kelley, J Mammen, M Vaughn, D Wuthiekanun, V Sungkakum, A Nisalak, A Day, N |
| author_sort | Blacksell, S |
| collection | OXFORD |
| description | BACKGROUND: The serological diagnosis of acute dengue virus infection relies on the detection of dengue-specific immunoglobulin M (IgM) antibodies. Immunochromatographic tests are rapid diagnostic tests (RDTs) that can be performed at the bedside, but they have not been fully validated for diagnosis of dengue infection. METHODS: More than 20 RDTs for diagnosis of acute dengue infection are commercially available. Of these, 8 were selected for evaluation of performance by use of characterized dengue and nondengue serum specimens, and results were compared with those of a previously published dengue IgM/IgG enzyme-linked immunosorbent assay in conjunction with dengue virus serotyping by reverse-transcriptase polymerase chain reaction. RESULTS: Assay sensitivities were low, ranging from 6.4% (95% confidence interval [CI], 4.0%-9.7%) to 65.3% (95% CI, 59.9%-70.5%), and specificities ranged from 69.1% (95% CI, 61.4%-76.0%) to 100% (95% CI, 97.8%-100%). Of the 8 tests, only 2 had sensitivities of >50%, the level considered to be clinically useful, and, of these, 1 had relatively low specificity (69.1%). Samples collected early in the infection were less likely to test positive than those collected later. A thermal stability study demonstrated a loss in performance of some RDTs when they were stored at a high ambient temperature for 3 months. CONCLUSIONS: Users of RDTs for dengue should be aware that many of these tests have a diagnostic accuracy that falls well below the manufacturers' claims. If an acute specimen yields a negative result, a convalescent serum sample should be tested to confirm the result. No RDT adequately differentiated primary and secondary dengue infections, and the tests should not be used for this purpose. |
| first_indexed | 2024-03-07T06:26:50Z |
| format | Journal article |
| id | oxford-uuid:f498c9e3-1af5-4ab6-b3f3-c0c40516a3b0 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T06:26:50Z |
| publishDate | 2006 |
| record_format | dspace |
| spelling | oxford-uuid:f498c9e3-1af5-4ab6-b3f3-c0c40516a3b02022-03-27T12:20:59ZThe comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:f498c9e3-1af5-4ab6-b3f3-c0c40516a3b0EnglishSymplectic Elements at Oxford2006Blacksell, SNewton, PBell, DKelley, JMammen, MVaughn, DWuthiekanun, VSungkakum, ANisalak, ADay, N BACKGROUND: The serological diagnosis of acute dengue virus infection relies on the detection of dengue-specific immunoglobulin M (IgM) antibodies. Immunochromatographic tests are rapid diagnostic tests (RDTs) that can be performed at the bedside, but they have not been fully validated for diagnosis of dengue infection. METHODS: More than 20 RDTs for diagnosis of acute dengue infection are commercially available. Of these, 8 were selected for evaluation of performance by use of characterized dengue and nondengue serum specimens, and results were compared with those of a previously published dengue IgM/IgG enzyme-linked immunosorbent assay in conjunction with dengue virus serotyping by reverse-transcriptase polymerase chain reaction. RESULTS: Assay sensitivities were low, ranging from 6.4% (95% confidence interval [CI], 4.0%-9.7%) to 65.3% (95% CI, 59.9%-70.5%), and specificities ranged from 69.1% (95% CI, 61.4%-76.0%) to 100% (95% CI, 97.8%-100%). Of the 8 tests, only 2 had sensitivities of >50%, the level considered to be clinically useful, and, of these, 1 had relatively low specificity (69.1%). Samples collected early in the infection were less likely to test positive than those collected later. A thermal stability study demonstrated a loss in performance of some RDTs when they were stored at a high ambient temperature for 3 months. CONCLUSIONS: Users of RDTs for dengue should be aware that many of these tests have a diagnostic accuracy that falls well below the manufacturers' claims. If an acute specimen yields a negative result, a convalescent serum sample should be tested to confirm the result. No RDT adequately differentiated primary and secondary dengue infections, and the tests should not be used for this purpose. |
| spellingShingle | Blacksell, S Newton, P Bell, D Kelley, J Mammen, M Vaughn, D Wuthiekanun, V Sungkakum, A Nisalak, A Day, N The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. |
| title | The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. |
| title_full | The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. |
| title_fullStr | The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. |
| title_full_unstemmed | The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. |
| title_short | The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. |
| title_sort | comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection |
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