1887

Chapter 17 : Point-of-Care Diagnostic Virology

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Preview this chapter:
Zoom in
Zoomout

Point-of-Care Diagnostic Virology, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555819156/9781555819149.ch17-1.gif /docserver/preview/fulltext/10.1128/9781555819156/9781555819149.ch17-2.gif

Abstract:

A point-of-care test (POCT) may be defined as an analytical or diagnostic test that is performed at the bedside or in a near-patient setting, a location distinct from a typical hospital laboratory (1). POCTs are technically less complex than traditional laboratory tests and therefore can be performed by health care professionals or nonmedical personnel. Some laboratories may also use POCTs as a rapid alternative to conventional methods or in facilities where complex testing is limited. Key features of POCTs are listed in Table 1. To be of value, POCTs should afford rapid results and have a high degree of sensitivity and specificity compared to more complex traditional testing performed in a laboratory. With reliable POCT results in hand, providers can make patient management decisions that improve outcomes for the patient or hospital. In some instances the impact may also be a more cost-effective solution compared to laboratory-based testing. POCTs should be simple to perform and interpret by nonlaboratory personnel using uncomplicated instrumentation, contain internal controls to ensure validity of results, have temperature-stable components that allow easy and prolonged storage, and be relatively inexpensive.

Citation: Dunn J, Chandramohan L. 2016. Point-of-Care Diagnostic Virology, p 229-241. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch17
Highlighted Text: Show | Hide
Loading full text...

Full text loading...

References

/content/book/10.1128/9781555819156.ch17
1. Plebani M . 2009. Does POCT reduce the risk of error in laboratory testing? Clin Chim Acta 404 : 59 64[CrossRef].[PubMed]
2. Glezen P, Denny FW . 1973. Epidemiology of acute lower respiratory disease in children. N Engl J Med 288 : 498 505[CrossRef].[PubMed]
3. Mahony JB . 2008. Detection of respiratory viruses by molecular methods. Clin Microbiol Rev 21 : 716 747[CrossRef].[PubMed]
4. Pavia AT . 2011. Viral infections of the lower respiratory tract: old viruses, new viruses, and the role of diagnosis. Clin Infect Dis 52( Suppl 4) : S284 S289[CrossRef].[PubMed]
5. Babcock HM, Merz LR, Dubberke ER, Fraser VJ . 2008. Case-control study of clinical features of influenza in hospitalized patients. Infect Control Hosp Epidemiol 29 : 921 926[CrossRef].[PubMed]
6. Heinonen S, Peltola V, Silvennoinen H, Vahlberg T, Heikkinen T . 2012. Signs and symptoms predicting influenza in children: a matched case-control analysis of prospectively collected clinical data. Eur J Clin Microbiol Infect Dis 31 : 1569 1574[CrossRef].[PubMed]
7. Poehling KA, Edwards KM, Weinberg GA, Szilagyi P, Staat MA, Iwane MK, Bridges CB, Grijalva CG, Zhu Y, Bernstein DI, Herrera G, Erdman D, Hall CB, Seither R, Griffin MR New Vaccine Surveillance Network . 2006. The underrecognized burden of influenza in young children. N Engl J Med 355 : 31 40[CrossRef].[PubMed]
8. Williams LO, Kupka NJ, Schmaltz SP, Barrett S, Uyeki TM, Jernigan DB . 2014. Rapid influenza diagnostic test use and antiviral prescriptions in outpatient settings pre- and post-2009 H1N1 pandemic. J Clin Virol 60 : 27 33[CrossRef].[PubMed]
9. Chartrand C, Leeflang MM, Minion J, Brewer T, Pai M . 2012. Accuracy of rapid influenza diagnostic tests: a meta-analysis. Ann Intern Med 156 : 500 511[CrossRef].[PubMed]
10. Petrozzino JJ, Smith C, Atkinson MJ . 2010. Rapid diagnostic testing for seasonal influenza: an evidence-based review and comparison with unaided clinical diagnosis. J Emerg Med 39 : 476 490.e1[CrossRef].[PubMed]
11. Babin SM, Hsieh YH, Rothman RE, Gaydos CA . 2011. A meta-analysis of point-of-care laboratory tests in the diagnosis of novel 2009 swine-lineage pandemic influenza A (H1N1). Diagn Microbiol Infect Dis 69 : 410 418[CrossRef].[PubMed]
12. Ginocchio CC, Zhang F, Manji R, Arora S, Bornfreund M, Falk L, Lotlikar M, Kowerska M, Becker G, Korologos D, de Geronimo M, Crawford JM . 2009. Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak. J Clin Virol 45 : 191 195[CrossRef].[PubMed]
13. Chu H, Lofgren ET, Halloran ME, Kuan PF, Hudgens M, Cole SR . 2012. Performance of rapid influenza H1N1 diagnostic tests: a meta-analysis. Influenza Other Respi Viruses 6 : 80 86[CrossRef].[PubMed]
14. Harper SA, Bradley JS, Englund JA, File TM, Gravenstein S, Hayden FG, McGeer AJ, Neuzil KM, Pavia AT, Tapper ML, Uyeki TM, Zimmerman RK Expert Panel of the Infectious Diseases Society of America . 2009. Seasonal influenza in adults and children—diagnosis, treatment, chemoprophylaxis, and institutional outbreak management: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis 48 : 1003 1032[CrossRef].[PubMed]
15. World Health Organization . 2010. Use of influenza rapid diagnostic tests. Available at: http://whqlibdoc.who.int/publications/2010/9789241599283_eng.pdf.
16. Centers for Disease Control and Prevention . Guidance for clinicians on the use of rapid influenza diagnostic tests. Available at: http://www.cdc.gov/flu/professionals/diagnosis/clinician_guidance_ridt.htm.
17. Abanses JC, Dowd MD, Simon SD, Sharma V . 2006. Impact of rapid influenza testing at triage on management of febrile infants and young children. Pediatr Emerg Care 22 : 145 149[CrossRef].[PubMed]
18. Benito-Fernández J, Vázquez-Ronco MA, Morteruel-Aizkuren E, Mintegui-Raso S, Sánchez-Etxaniz J, Fernández-Landaluce A . 2006. Impact of rapid viral testing for influenza A and B viruses on management of febrile infants without signs of focal infection. Pediatr Infect Dis J 25 : 1153 1157[CrossRef].[PubMed]
19. Hojat K, Duppenthaler A, Aebi C . 2013. Impact of the availability of an influenza virus rapid antigen test on diagnostic decision making in a pediatric emergency department. Pediatr Emerg Care 29 : 696 698[CrossRef].[PubMed]
20. Poehling KA, Zhu Y, Tang Y-W, Edwards K . 2006. Accuracy and impact of a point-of-care rapid influenza test in young children with respiratory illnesses. Arch Pediatr Adolesc Med 160 : 713 718[CrossRef].[PubMed]
21. Jennings LC, Skopnik H, Burckhardt I, Hribar I, Del Piero L, Deichmann KA . 2009. Effect of rapid influenza testing on the clinical management of paediatric influenza. Influenza Other Respi Viruses 3 : 91 98[CrossRef].[PubMed]
22. Theocharis G, Vouloumanou EK, Rafailidis PI, Spiropoulos T, Barbas SG, Falagas ME . 2010. Evaluation of a direct test for seasonal influenza in outpatients. Eur J Intern Med 21 : 434 438[CrossRef].[PubMed]
23. Blaschke AJ, Shapiro DJ, Pavia AT, Byington CL, Ampofo K, Stockmann C, Hersh AL . 2014. A national study of the impact of rapid influenza testing on clinical care in the emergency department. J Pediatric Infect Dis Soc 3 : 112 118[CrossRef].[PubMed]
24. Özkaya E, Cambaz N, Coşkun Y, Mete F, Geyik M, Samanci N . 2009. The effect of rapid diagnostic testing for influenza on the reduction of antibiotic use in paediatric emergency department. Acta Paediatr 98 : 1589 1592[CrossRef].[PubMed]
25. Bonner AB, Monroe KW, Talley LI, Klasner AE, Kimberlin DW . 2003. Impact of the rapid diagnosis of influenza on physician decision-making and patient management in the pediatric emergency department: results of a randomized, prospective, controlled trial. Pediatrics 112 : 363 367[CrossRef].[PubMed]
26. Church DL, Davies HD, Mitton C, Semeniuk H, Logue M, Maxwell C, Donaldson C . 2002. Clinical and economic evaluation of rapid influenza a virus testing in nursing homes in Calgary, Canada. Clin Infect Dis 34 : 790 795[CrossRef].[PubMed]
27. U.S. Department of Health and Human Services . 2014. Microbiology devices; reclassification of influenza virus antigen detection test systems intended for use directly with clinical specimens. 21 CFR Part 866 Available at: https://www.federalregister.gov/articles/2014/05/22/2014-11635/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for.
28. Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ . 1999. Bronchiolitis-associated hospitalizations among US children, 1980–1996. JAMA 282 : 1440 1446[CrossRef].[PubMed]
29. Mackie PL, Joannidis PA, Beattie J . 2001. Evaluation of an acute point-of-care system screening for respiratory syncytial virus infection. J Hosp Infect 48 : 66 71[CrossRef].[PubMed]
30. Walsh EE . 2011. Respiratory syncytial virus infection in adults. Semin Respir Crit Care Med 32 : 423 432[CrossRef].[PubMed]
31. Casiano-Colón AE, Hulbert BB, Mayer TK, Walsh EE, Falsey AR . 2003. Lack of sensitivity of rapid antigen tests for the diagnosis of respiratory syncytial virus infection in adults. J Clin Virol 28 : 169 174[CrossRef].[PubMed]
32. Khanom AB, Velvin C, Hawrami K, Schutten M, Patel M, Holmes MV, Atkinson C, Breuer J, Fitzsimons J, Geretti AM . 2011. Performance of a nurse-led paediatric point of care service for respiratory syncytial virus testing in secondary care. J Infect 62 : 52 58[CrossRef].[PubMed]
33. Mills JM, Harper J, Broomfield D, Templeton KE . 2011. Rapid testing for respiratory syncytial virus in a paediatric emergency department: benefits for infection control and bed management. J Hosp Infect 77 : 248 251[CrossRef].[PubMed]
34. Dizdar EA, Aydemir C, Erdeve O, Sari FN, Oguz S, Uras N, Dilmen U . 2010. Respiratory syncytial virus outbreak defined by rapid screening in a neonatal intensive care unit. J Hosp Infect 75 : 292 294[CrossRef].[PubMed]
35. Purcell K, Fergie J . 2002. Concurrent serious bacterial infections in 2396 infants and children hospitalized with respiratory syncytial virus lower respiratory tract infections. Arch Pediatr Adolesc Med 156 : 322 324[CrossRef].[PubMed]
36. Titus MO, Wright SW . 2003. Prevalence of serious bacterial infections in febrile infants with respiratory syncytial virus infection. Pediatrics 112 : 282 284[CrossRef].[PubMed]
37. Flaherman V, Li S, Ragins A, Masaquel A, Kipnis P, Escobar GJ . 2010. Respiratory syncytial virus testing during bronchiolitis episodes of care in an integrated health care delivery system: a retrospective cohort study. Clin Ther 32 : 2220 2229[CrossRef].[PubMed]
38. Thibeault R, Gilca R, Côté S, De Serres G, Boivin G, Déry P . 2007. Antibiotic use in children is not influenced by the result of rapid antigen detection test for the respiratory syncytial virus. J Clin Virol 39 : 169 174[CrossRef].[PubMed]
39. Parashar UD, Gibson CJ, Bresee JS, Glass RI . 2006. Rotavirus and severe childhood diarrhea. Emerg Infect Dis 12 : 304 306[CrossRef].[PubMed]
40. Borrows CL, Turner PC . 2014. Seasonal screening for viral gastroenteritis in young children and elderly hospitalized patients: is it worthwhile? J Hosp Infect 87 : 98 102[CrossRef].[PubMed]
41. Festini F, Cocchi P, Mambretti D, Tagliabue B, Carotti M, Ciofi D, Biermann KP, Schiatti R, Ruggeri FM, De Benedictis FM, Plebani A, Guarino A, de Martino M . 2010. Nosocomial Rotavirus Gastroenteritis in pediatric patients: a multi-center prospective cohort study. BMC Infect Dis 10 : 235[CrossRef].[PubMed]
42. Trivedi TK, DeSalvo T, Lee L, Palumbo A, Moll M, Curns A, Hall AJ, Patel M, Parashar UD, Lopman BA . 2012. Hospitalizations and mortality associated with norovirus outbreaks in nursing homes, 2009–2010. JAMA 308 : 1668 1675[CrossRef].[PubMed]
43. Kak V . 2007. Infections in confined spaces: cruise ships, military barracks, and college dormitories. Infect Dis Clin North Am 21 : 773 784, ix–x[CrossRef].[PubMed]
44. Beersma MF, Sukhrie FH, Bogerman J, Verhoef L, Mde Melo M, Vonk AG, Koopmans M . 2012. Unrecognized norovirus infections in health care institutions and their clinical impact. J Clin Microbiol 50 : 3040 3045[CrossRef].[PubMed]
45. Battaglioli G, Nazarian EJ, Lamson D, Musser KA, St George K . 2012. Evaluation of the RIDAQuick norovirus immunochromatographic test kit. J Clin Virol 53 : 262 264[CrossRef].[PubMed]
46. Geginat G, Kaiser D, Schrempf S . 2012. Evaluation of third-generation ELISA and a rapid immunochromatographic assay for the detection of norovirus infection in fecal samples from inpatients of a German tertiary care hospital. Eur J Clin Microbiol Infect Dis 31 : 733 737[CrossRef].[PubMed]
47. Kirby A, Gurgel RQ, Dove W, Vieira SC, Cunliffe NA, Cuevas LE . 2010. An evaluation of the RIDASCREEN and IDEIA enzyme immunoassays and the RIDAQUICK immunochromatographic test for the detection of norovirus in faecal specimens. J Clin Virol 49 : 254 257[CrossRef].[PubMed]
48. Ambert-Balay K, Pothier P . 2013. Evaluation of 4 immunochromatographic tests for rapid detection of norovirus in faecal samples. J Clin Virol 56 : 194 198[CrossRef].[PubMed]
49. Centers for Disease Control and Prevention . 1998. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Recomm Rep 47( RR-19) : 139.[PubMed]
50. Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, Jewett A, Baack B, Rein DB, Patel N, Alter M, Yartel A, Ward JW Centers for Disease Control and Prevention . 2012. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR Recomm Rep 61( RR-4) : 1 32.[PubMed]
51. Shivkumar S, Peeling R, Jafari Y, Joseph L, Pant Pai N . 2012. Accuracy of rapid and point-of-care screening tests for hepatitis C: a systematic review and meta-analysis. Ann Intern Med 157 : 558 566[CrossRef].[PubMed]
52. Mabey D, Peeling RW, Perkins MD . 2001. Rapid and simple point of care diagnostics for STIs. Sex Transm Infect 77 : 397 398[CrossRef].[PubMed]
53. Lee SR, Kardos KW, Schiff E, Berne CA, Mounzer K, Banks AT, Tatum HA, Friel TJ, Demicco MP, Lee WM, Eder SE, Monto A, Yearwood GD, Guillon GB, Kurtz LA, Fischl M, Unangst JL, Kriebel L, Feiss G, Roehler M . 2011. Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. J Virol Methods 172 : 27 31[CrossRef].[PubMed]
54. Smith BD, Drobeniuc J, Jewett A, Branson BM, Garfein RS, Teshale E, Kamili S, Weinbaum CM . 2011. Evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus. J Infect Dis 204 : 825 831[CrossRef].[PubMed]
55. Lee SR, Yearwood GD, Guillon GB, Kurtz LA, Fischl M, Friel T, Berne CA, Kardos KW . 2010. Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection. J Clin Virol 48 : 15 17[CrossRef].[PubMed]
56. Cha YJ, Park Q, Kang ES, Yoo BC, Park KU, Kim JW, Hwang YS, Kim MH . 2013. Performance evaluation of the OraQuick hepatitis C virus rapid antibody test. Ann Lab Med 33 : 184 189[CrossRef].[PubMed]
57. Smith BD, Teshale E, Jewett A, Weinbaum CM, Neaigus A, Hagan H, Jenness SM, Melville SK, Burt R, Thiede H, Al-Tayyib A, Pannala PR, Miles IW, Oster AM, Smith A, Finlayson T, Bowles KE, Dinenno EA . 2011. Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites. Clin Infect Dis 53 : 780 786[CrossRef].[PubMed]
58. Hickman M, McDonald T, Judd A, Nichols T, Hope V, Skidmore S, Parry JV . 2008. Increasing the uptake of hepatitis C virus testing among injecting drug users in specialist drug treatment and prison settings by using dried blood spots for diagnostic testing: a cluster randomized controlled trial. J Viral Hepat 15 : 250 254[CrossRef].[PubMed]
59. Drobnik A, Judd C, Banach D, Egger J, Konty K, Rude E . 2011. Public health implications of rapid hepatitis C screening with an oral swab for community-based organizations serving high-risk populations. Am J Public Health 101 : 2151 2155[CrossRef].[PubMed]
60. Hayes B, Briceno A, Asher A, Yu M, Evans JL, Hahn JA, Page K . 2014. Preference, acceptability and implications of the rapid hepatitis C screening test among high-risk young people who inject drugs. BMC Public Health 14 : 645[CrossRef].[PubMed]
61. Hurt C, Tammaro D . 2007. Diagnostic evaluation of mononucleosis-like illnesses. Am J Med 120 : 911.e1 911.e8[CrossRef].[PubMed]
62. Linderholm M, Boman J, Juto P, Linde A . 1994. Comparative evaluation of nine kits for rapid diagnosis of infectious mononucleosis and Epstein-Barr virus-specific serology. J Clin Microbiol 32 : 259 261.[PubMed]
63. Elgh F, Linderholm M . 1996. Evaluation of six commercially available kits using purified heterophile antigen for the rapid diagnosis of infectious mononucleosis compared with Epstein-Barr virus-specific serology. Clin Diagn Virol 7 : 17 21[CrossRef].[PubMed]
64. Gerber MA, Shapiro ED, Ryan RW, Bell GL . 1996. Evaluations of enzyme-linked immunosorbent assay procedure for determining specific Epstein-Barr virus serology and of rapid test kits for diagnosis for infectious mononucleosis. J Clin Microbiol 34 : 3240 3241.[PubMed]
65. Svahn A, Magnusson M, Jägdahl L, Schloss L, Kahlmeter G, Linde A . 1997. Evaluation of three commercial enzyme-linked immunosorbent assays and two latex agglutination assays for diagnosis of primary Epstein-Barr virus infection. J Clin Microbiol 35 : 2728 2732.[PubMed]
66. Llor C, Hernández M, Hernández S, Martínez T, Gómez FF . 2012. Validity of a point-of-care based on heterophile antibody detection for the diagnosis of infectious mononucleosis in primary care. Eur J Gen Pract 18 : 15 21[CrossRef].[PubMed]
67. Bruu AL, Hjetland R, Holter E, Mortensen L, Natås O, Petterson W, Skar AG, Skarpaas T, Tjade T, Asjø B . 2000. Evaluation of 12 commercial tests for detection of Epstein-Barr virus-specific and heterophile antibodies. Clin Diagn Lab Immunol 7 : 451 456.[PubMed]
68. Keenan PA, Keenan JM, Branson BM . 2005. Rapid HIV testing. Wait time reduced from days to minutes. Postgrad Med 117 : 47 52.[PubMed]
69. Centers for Disease Control and Prevention . 2014. List of CLIA-waived rapid HIV tests. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm?start_search=H.
70. Centers for Disease Control and Prevention . 2014. FDA-approved Rapid HIV Antibody Screening Tests. Available at: https://www.cdc.gov/topics/testing/rapid/rt-comparison.htm.
71. World Health Organization . 2013. HIV Assays: Operational Characteristics (Phase I). Report 17: HIV rapid diagnostic tests. WHO, Geneva. Available at: http://www.who.int/diagnostics_laboratory/evaluations/hiv/131107_hiv_assays17_final.pdf.
72. Branson B . 2003. Point-of-care rapid tests for HIV antibodies. Laboratoriums Medizin 27 : 288 295.
73. Pant Pai N, Balram B, Shivkumar S, Martinez-Cajas JL, Claessens C, Lambert G, Peeling RW, Joseph L . 2012. Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis. Lancet Infect Dis 12 : 373 380[CrossRef].[PubMed]
74. Garg N, Gautam V, Gill PS, Arora B, Arora DR . 2006. Comparison of salivary and serum antibody detection in HIV-1 infection by ELISA and rapid methods in India. Trop Doct 36 : 108 109[CrossRef].[PubMed]
75. Delaney KP, Branson BM, Uniyal A, Kerndt PR, Keenan PA, Jafa K, Gardner AD, Jamieson DJ, Bulterys M . 2006. Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies. AIDS 20 : 1655 1660[CrossRef].[PubMed]
76. Holguín A, Gutiérrez M, Portocarrero N, Rivas P, Baquero M . 2009. Performance of OraQuick Advance Rapid HIV-1/2 Antibody Test for detection of antibodies in oral fluid and serum/plasma in HIV-1+ subjects carrying different HIV-1 subtypes and recombinant variants. J Clin Virol 45 : 150 152[CrossRef].[PubMed]
77. De Cock L, Hutse V, Verhaegen E, Quoilin S, Vandenberghe H, Vranckx R . 2004. Detection of HCV antibodies in oral fluid. J Virol Methods 122 : 179 183[CrossRef].[PubMed]
78. Pai NP, Tulsky JP, Cohan D, Colford JM Jr, Reingold AL . 2007. Rapid point-of-care HIV testing in pregnant women: a systematic review and meta-analysis. Trop Med Int Health 12 : 162 173[CrossRef].[PubMed]
79. Bulterys M, Jamieson DJ, O'Sullivan MJ, Cohen MH, Maupin R, Nesheim S, Webber MP, Van Dyke R, Wiener J, Branson BM ; Mother-Infant Rapid Intervention At Delivery (MIRIAD) Study Group . 2004. Rapid HIV-1 testing during labor: a multicenter study. JAMA 292 : 219 223[CrossRef].[PubMed]
80. Kelen GD, Shahan JB, Quinn TC . 1999. Emergency department-based HIV screening and counseling: experience with rapid and standard serologic testing. Ann Emerg Med 33 : 147 155[CrossRef].[PubMed]
81. Pai NP, Barick R, Tulsky JP, Shivkumar PV, Cohan D, Kalantri S, Pai M, Klein MB, Chhabra S . 2008. Impact of round-the-clock, rapid oral fluid HIV testing of women in labor in rural India. PLoS Med 5 : e92[CrossRef].[PubMed]
82. Pai NP, Klein MB . 2009. Rapid testing at labor and delivery to prevent mother-to-child HIV transmission in developing settings: issues and challenges. Womens Health (Lond Engl) 5 : 55 62[CrossRef].[PubMed]
83. Puro V, Francisci D, Sighinolfi L, Civljak R, Belfiori B, Deparis P, Roda R, Modestino R, Ghinelli F, Ippolito G . 2004. Benefits of a rapid HIV test for evaluation of the source patient after occupational exposure of healthcare workers. J Hosp Infect 57 : 179 182[CrossRef].[PubMed]
84. Turner SD, Anderson K, Slater M, Quigley L, Dyck M, Guiang CB . 2013. Rapid point-of-care HIV testing in youth: a systematic review. J Adolesc Health 53 : 683 691[CrossRef].[PubMed]
85. Donnell-Fink LA, Arbelaez C, Collins JE, Novais A, Case A, Pisculli ML, Reichmann WM, Katz JN, Losina E, Walensky RP . 2012. Acceptability of fingerstick versus oral fluid rapid HIV testing: results from the universal screening for HIV infection in the emergency room (USHER Phase II) randomized controlled trial. J Acquir Immune Defic Syndr 61 : 588 592[CrossRef].[PubMed]
86. Pant Pai N, Sharma J, Shivkumar S, Pillay S, Vadnais C, Joseph L, Dheda K, Peeling RW . 2013. Supervised and unsupervised self-testing for HIV in high- and low-risk populations: a systematic review. PLoS Med 10 : e1001414[CrossRef].[PubMed]
87. Lubelchek R, Kroc K, Hota B, Sharief R, Muppudi U, Pulvirenti J, Weinstein RA . 2005. The role of rapid vs conventional human immunodeficiency virus testing for inpatients: effects on quality of care. Arch Intern Med 165 : 1956 1960[CrossRef].[PubMed]
88. Sanders GD, Bayoumi AM, Sundaram V, Bilir SP, Neukermans CP, Rydzak CE, Douglass LR, Lazzeroni LC, Holodniy M, Owens DK . 2005. Cost-effectiveness of screening for HIV in the era of highly active antiretroviral therapy. N Engl J Med 352 : 570 585[CrossRef].[PubMed]
89. Shrestha RK, Clark HA, Sansom SL, Song B, Buckendahl H, Calhoun CB, Hutchinson AB, Heffelfinger JD . 2008. Cost-effectiveness of finding new HIV diagnoses using rapid HIV testing in community-based organizations. Public Health Rep 123( Suppl 3) : 94 100.[PubMed]
90. Holland CA, Kiechle FL . 2005. Point-of-care molecular diagnostic systems—past, present and future. Curr Opin Microbiol 8 : 504 509[CrossRef].[PubMed]
91. Niemz A, Ferguson TM, Boyle DS . 2011. Point-of-care nucleic acid testing for infectious diseases. Trends Biotechnol 29 : 240 250[CrossRef].[PubMed]
92. Nicosia A, Bandi M, DiFatta T, Ravanini P . 2013. Usefulness of a real-time polymerase chain reaction (RT-PCR) point-of-care testing (POCT) instrument for viral emergencies. Abstr R2694. 23rd Eur Soc Clin Microbiol Infect Dis Congress.
93. Ninove L, Nougairede A, Gazin C, Zandotti C, Drancourt M, de Lamballerie X, Charrel RN . 2011. Comparative detection of enterovirus RNA in cerebrospinal fluid: GeneXpert system vs. real-time RT-PCR assay. Clin Microbiol Infect 17 : 1890 1894[CrossRef].[PubMed]
94. Menasalvas-Ruiz AI, Salvador-García C, Moreno-Docón A, Alfayate-Miguélez S, Pérez Cánovas C, Sánchez-Solís M . 2013. Enterovirus reverse transcriptase polymerase chain reaction assay in cerebrospinal fluid: an essential tool in meningitis management in childhood. Enferm Infecc Microbiol Clin 31 : 71 75[CrossRef].[PubMed]
95. Rogers B, Shankar P, Jerris R, Kotzbauer D, Anderson E, Watson J, O'Brien L, Uwindatwa F, McNamara K, Bost J . 2015. Impact of a rapid respiratory panel test on patient outcomes. Arch Pathol Lab Med. 139 : 636 641.[PubMed].
96. Nakao A, Hisata K, Matsunaga N, Fujimori M, Yoshikawa N, Komatsu M, Kikuchi K, Takahashi H, Shimizu T . 2014. The clinical utility of a near patient care rapid microarray-based diagnostic test for influenza and respiratory syncytial virus infections in the pediatric setting. Diagn Microbiol Infect Dis 78 : 363 367[CrossRef].[PubMed]
97. Alby K, Popowitch EB, Miller MB . 2013. Comparative evaluation of the Nanosphere Verigene RV+ assay and the Simplexa Flu A/B & RSV kit for detection of influenza and respiratory syncytial viruses. J Clin Microbiol 51 : 352 353[CrossRef].[PubMed]
98. Bell JJ, Selvarangan R . 2014. Evaluation of the Alere I influenza A&B nucleic acid amplification test by use of respiratory specimens collected in viral transport medium. J Clin Microbiol 52 : 3992 3995[CrossRef].[PubMed]
99. Wu LT, Thomas I, Curran MD, Ellis JS, Parmar S, Goel N, Sharma PI, Allain JP, Lee HH . 2013. Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection. J Clin Microbiol 51 : 3031 3038[CrossRef].[PubMed]
100. Khare R, Espy MJ, Cebelinski E, Boxrud D, Sloan LM, Cunningham SA, Pritt BS, Patel R, Binnicker MJ . 2014. Comparative evaluation of two commercial multiplex panels for detection of gastrointestinal pathogens by use of clinical stool specimens. J Clin Microbiol 52 : 3667 3673[CrossRef].[PubMed]
101. Centers for Medicare and Medicaid Services, Department of Health and Human Services . 1992. Clinical laboratory improvement amendments of 1988; final rule. Fed Regist 57 : 71397186. Codified at 7142 CFR 49342 CFR part 49493.
102. CLSI . 2006. Point-of-care in vitro diagnostic (IVD) testing; Approved Guideline. CLSI document POCT4-A2. CLSI, Wayne, PA.
103. CLSI . 2010. Quality practices in noninstrumental point-of-care testing: and instructional manual and resources for health care workers: approved guideline. CLSI document POCT08-A. CLSI, Wayne, PA.
104. Lewandrowski K, Gregory K, Macmillan D . 2011. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. Arch Pathol Lab Med 135 : 1405 1414[CrossRef].[PubMed]
105. Fox JW, Cohen DM, Marcon MJ, Cotton WH, Bonsu BK . 2006. Performance of rapid streptococcal antigen testing varies by personnel. J Clin Microbiol 44 : 3918 3922[CrossRef].[PubMed]

Tables

Generic image for table
TABLE 1

Essential features of point-of-care and near point-of-care testing

Citation: Dunn J, Chandramohan L. 2016. Point-of-Care Diagnostic Virology, p 229-241. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch17
Generic image for table
TABLE 2

The FDA-proposed minimal performance criteria for RIDTs

Citation: Dunn J, Chandramohan L. 2016. Point-of-Care Diagnostic Virology, p 229-241. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch17
Generic image for table
TABLE 3

Benefits of rapid HIV antibody testing

Citation: Dunn J, Chandramohan L. 2016. Point-of-Care Diagnostic Virology, p 229-241. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch17

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error