tetano
Editor, Senior Moderator
J Clin Microbiol. 2012 Feb 22. [Epub ahead of print]
Clinical Validation of a Point-of-Care multiplexed in vitro immunoassay using monoclonal antibodies (MSD(R) Influenza Test) in 4 hospitals in Vietnam.
van Doorn HR, Kinh NV, Tuan HM, Tuan TA, Minh NN, Bryant JE, Hang VT, Uyen LT, Thinh LQ, Anh TT, Lan NP, Trung NV, Taylor W, Merson L, Wertheim HF, Farrar J, Wolbers M, Chau NV, de Jong MD.
Source
South East Asian Infectious diseases Clinical Research Network.
Abstract
Background: Point-of-care (POC) diagnostic tests for influenza can considerably shorten the time to clinical decision making. An investigational POC test based on a multiplexed immunoassay was developed by Meso Scale Diagnostics, LLC (MSD) with the objective to make a more sensitive rapid test that can also subtype influenza A viruses (1977 H1, H3 and H5)Methods: Between February and November 2010 we conducted a prospective multicenter study at 4 hospitals in Vietnam, and compared the performance of this test to WHO/US CDC real-time RT-PCR on nasal and throat swabs of patients presenting with influenza-like illness.Results: 563 adults and children were enrolled with a median age of 25 months. Sensitivity and specificity of the test with combined results from nasal and throat samples were 74.0% (131/177) and 99.7% (351/352), respectively, compared to RT-PCR. The POC test was as sensitive for influenza virus B as for A (74.4% [64/86] vs. 73.6% [67/91]). Positivity rate was associated with lower Ct values (marker for higher viral loads), sample type (nasal swab 73.6% vs. throat swab 52.4%), and younger age. A total of 210 (18.7%) out of 1126 MSD tests failed, and for 34 (6%) of patients both tests samples failed (these were excluded from the performance analysis). Subtyping could only be assessed for influenza virus A/H3N2, as 1977 H1N1 was not circulating at the time and no H5N1 patients were enrolled, and was only successful in 9/54 patients infected with H3 influenza who had a positive POC test result for influenza virus A.Conclusion: This novel POC test provided highly sensitive detection of influenza virus A and B, when compared to reported sensitivities of other rapid tests. However, 18.7% of tests failed for technical reasons and subtyping for H3 was poor. Drawbacks to the technology include the requirement for a dedicated reader instrument, and the need for continual updating of subtyping antibodies within the test array.
PMID:
22357497
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22357497
Clinical Validation of a Point-of-Care multiplexed in vitro immunoassay using monoclonal antibodies (MSD(R) Influenza Test) in 4 hospitals in Vietnam.
van Doorn HR, Kinh NV, Tuan HM, Tuan TA, Minh NN, Bryant JE, Hang VT, Uyen LT, Thinh LQ, Anh TT, Lan NP, Trung NV, Taylor W, Merson L, Wertheim HF, Farrar J, Wolbers M, Chau NV, de Jong MD.
Source
South East Asian Infectious diseases Clinical Research Network.
Abstract
Background: Point-of-care (POC) diagnostic tests for influenza can considerably shorten the time to clinical decision making. An investigational POC test based on a multiplexed immunoassay was developed by Meso Scale Diagnostics, LLC (MSD) with the objective to make a more sensitive rapid test that can also subtype influenza A viruses (1977 H1, H3 and H5)Methods: Between February and November 2010 we conducted a prospective multicenter study at 4 hospitals in Vietnam, and compared the performance of this test to WHO/US CDC real-time RT-PCR on nasal and throat swabs of patients presenting with influenza-like illness.Results: 563 adults and children were enrolled with a median age of 25 months. Sensitivity and specificity of the test with combined results from nasal and throat samples were 74.0% (131/177) and 99.7% (351/352), respectively, compared to RT-PCR. The POC test was as sensitive for influenza virus B as for A (74.4% [64/86] vs. 73.6% [67/91]). Positivity rate was associated with lower Ct values (marker for higher viral loads), sample type (nasal swab 73.6% vs. throat swab 52.4%), and younger age. A total of 210 (18.7%) out of 1126 MSD tests failed, and for 34 (6%) of patients both tests samples failed (these were excluded from the performance analysis). Subtyping could only be assessed for influenza virus A/H3N2, as 1977 H1N1 was not circulating at the time and no H5N1 patients were enrolled, and was only successful in 9/54 patients infected with H3 influenza who had a positive POC test result for influenza virus A.Conclusion: This novel POC test provided highly sensitive detection of influenza virus A and B, when compared to reported sensitivities of other rapid tests. However, 18.7% of tests failed for technical reasons and subtyping for H3 was poor. Drawbacks to the technology include the requirement for a dedicated reader instrument, and the need for continual updating of subtyping antibodies within the test array.
PMID:
22357497
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22357497