Clinical validation of a point-of-care multiplexed in vitro immunoassay using monoclonal antibodies (the MSD influenza test) in four hospitals in Vietnam.

Clinical validation of a point-of-care multiplexed in vitro immunoassay using monoclonal antibodies (the MSD influenza test) in four hospitals in Vietnam. van Doorn, H. R., Kinh, N. v., Tuan, H. M., Tuan, T. A., Minh, N. N. Q., Bryant, J. E., Hang, V. t. T., Uyen, L. t. T., Thinh, L. Q., Anh, T. t. N., Lan, N. P. H., Trung, N. V., Taylor, W., Merson, L., Wertheim, H. F. L., Farrar, J., Wolbers, M., Chau, N. v. V., & de Jong, M. D. Journal of clinical microbiology, 50(5):1621–1625, May, 2012.
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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). Between February and November 2010, we conducted a prospective multicenter study at four hospitals in Vietnam and compared the performance of this test to that of the WHO/CDC real-time reverse transcriptase PCR (RT-PCR) on nasal and throat swab specimens from patients presenting with influenza-like illness. Five hundred sixty-three adults and children with a median age of 25 months were enrolled. Sensitivity and specificity of the test with combined results from nasal and throat swab 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 influenza virus A (74.4% [64/86] versus 73.6% [67/91]). The positivity rate was associated with lower cycle threshold values (a marker for higher viral loads), sample type (73.6% for nasal swab versus 52.4% for throat swab), and younger age. A total of 210 (18.7%) out of 1,126 MSD tests failed, and for 34 (6%) of patients, both test samples failed (these were excluded from the performance analysis). Subtyping could be assessed only for influenza virus A/H3N2, as 1977 H1N1 was not circulating at the time and no

@article{van_doorn_clinical_2012,
	title = {Clinical validation of a point-of-care multiplexed in vitro immunoassay using monoclonal antibodies (the {MSD} influenza test) in four hospitals in {Vietnam}.},
	volume = {50},
	issn = {1098-660X 0095-1137},
	doi = {10.1128/JCM.00085-12},
	abstract = {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). Between February and November 2010, we conducted a prospective multicenter study at four hospitals in Vietnam and compared the performance of this test to that of the WHO/CDC real-time reverse transcriptase PCR (RT-PCR) on nasal and throat swab specimens from patients presenting with influenza-like illness. Five hundred sixty-three adults and children with a median age of 25 months were enrolled. Sensitivity and specificity of the test with combined results from nasal and throat swab 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 influenza virus A (74.4\% [64/86] versus 73.6\% [67/91]). The positivity rate was associated with lower cycle threshold values (a marker for higher viral loads), sample type (73.6\% for nasal swab versus 52.4\% for throat swab), and younger age. A total of 210 (18.7\%) out of 1,126 MSD tests  failed, and for 34 (6\%) of patients, both test samples failed (these were excluded from the performance analysis). Subtyping could be assessed only for influenza virus A/H3N2, as 1977 H1N1 was not circulating at the time and no},
	language = {eng},
	number = {5},
	journal = {Journal of clinical microbiology},
	author = {van Doorn, H. Rogier and Kinh, Nguyen van and Tuan, Ha Manh and Tuan, Tran Anh and Minh, Ngo Ngoc Quang and Bryant, Juliet E. and Hang, Vu thi Ty and Uyen, Le thi Tham and Thinh, Le Quoc and Anh, Tran thi Ngoc and Lan, Nguyen Phu Huong and Trung, Nguyen Vu and Taylor, Walter and Merson, Laura and Wertheim, Heiman F. L. and Farrar, Jeremy and Wolbers, Marcel and Chau, Nguyen van Vinh and de Jong, Menno D.},
	month = may,
	year = {2012},
	pmid = {22357497},
	pmcid = {PMC3347120},
	keywords = {*Point-of-Care Systems, Adolescent, Adult, Aged, Antibodies, Monoclonal, Antibodies, Viral, Antigens, Viral/*analysis/immunology, Child, Child, Preschool, Female, Hospitals, Humans, Immunoassay/methods, Infant, Influenza, Human/*diagnosis, Male, Middle Aged, Orthomyxoviridae/classification/immunology/*isolation \& purification, Sensitivity and Specificity, Vietnam, Young Adult},
	pages = {1621--1625},
}

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