2009
DOI: 10.3201/eid1510.091186
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Poor Clinical Sensitivity of Rapid Antigen Test for Influenza A Pandemic (H1N1) 2009 Virus

Abstract: Influenza A pandemic (H1N1) 2009 virus RNA was detected by reverse transcription–PCR in 144 clinical samples from Bonn, Germany. A common rapid antigen–based test detected the virus in only 11.1% of these samples. The paramount feature of rapid test–positive samples was high virus concentration. Antigen-based rapid tests appear unsuitable for virologic diagnostics in the current pandemic.

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Cited by 165 publications
(120 citation statements)
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“…This goes in line with the results assessing the performance of BinaxNOW Influenza A&B Rapid Test® in PCR-positive clinical specimens [3,5]. A positive correlation between sensitivity and viral load has also been found in studies assessing rapid tests during a regular influenza season [3].…”
Section: Performance Of Influenzatop®supporting
confidence: 83%
“…This goes in line with the results assessing the performance of BinaxNOW Influenza A&B Rapid Test® in PCR-positive clinical specimens [3,5]. A positive correlation between sensitivity and viral load has also been found in studies assessing rapid tests during a regular influenza season [3].…”
Section: Performance Of Influenzatop®supporting
confidence: 83%
“…Rapid antigen tests generally have low sensitivity (11%-69%) for detecting pandemic H1N1/09 (50)(51)(52)(53)(54). The sensitivity of all rapid tests decreased markedly with decreasing virus titres in specimens (51).…”
Section: Laboratory Diagnosismentioning
confidence: 99%
“…H1N1 was diagnosed by a positive result of an influenza A test kit (rapid test) or by clinical symptoms, not by culture or molecular diagnostic techniques. The sensitivity of the rapid test is said to be about 50%, and an extreme report found only 11% sensitivity compared with PCR 15) . Thus, diagnosis using only the rapid test may miss a large number of true infections.…”
Section: Discussionmentioning
confidence: 99%