'Sensitivity' and 'specificity' reconsidered: The meaning of these terms in analytical and diagnostic settings

Annals of Internal Medicine

Volumn 126, Issue 1, 1997, Pages 91-94

  Saah, Alfred J ^a   Hoover, Donald R ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ANALYTICAL ERROR; ASSAY; CONTAMINATION; DIAGNOSTIC ACCURACY; DIAGNOSTIC ERROR; LABORATORY TEST; NOMENCLATURE; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; REVIEW;

EID: 0031024931     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-126-1-199701010-00026     Document Type: Review

References (26)

1. Cao Y, Qin L, Zhang L, Safrit J, Ho DD. Virologic and immunologic characterization of long-term survivors of human immunodeficiency virus type 1 infection. N Engl J Med. 1995;332:201-8.
2. Cuzick J, Szarewski A, Terry G, Ho L, Hanby A, Maddox P, et al. Human papillomavirus testing in primary cervical screening. Lancet. 1995;345: 1533-6.
3. Vandamme AM. Polymerase chain reaction (PCR) as a diagnostic tool in HIV infection. Verh K Acad Geneeskd Belg. 1994;56:231-65.
4. Bournique B, Akar A, Broly H, Ajana F, Counis R, Scholler R. Detection of HIV-1 infections by PCR: evaluation in a seropositive subject population. Mol Cell Probes. 1992;6:443-50.
5. De Rossi A, Ades AE, Mammano F, Del Mistro A, Amadori A, Giaquinto C, et al. Antigen detection, virus culture, polymerase chain reaction, and in vitro antibody production in the diagnosis of vertically transmitted HIV-1 infection. AIDS. 1991;5:15-20.
6. Garcia-Ferrer FJ, Laycock KA, Buerger DG, Flowers BE, Foos RY, Pepose JS. Screening corneas for human immunodeficiency virus type 1 proviral DNA by polymerase chain reaction. Am J Ophthalmol. 1995;119:7-13.
7. Zaaijer HL, Cuypers HT, Reesink HW, Winkel IN, Gerken G, Lelie PN. Reliability of polymerase chain reaction for detection of hepatitis C virus. Lancet. 1993;341:722-4.
8. Noordhoek GT, van Embden JD, Kolk AH. Questionable reliability of the polymerase chain reaction in the detection of Mycobacterium tuberculosis [Letter]. N Engl J Med. 1993;329:2036.
9. Tietz NW, ed. Textbook of Clinical Chemistry. Philadelphia: WB Saunders; 1986.
10. Babu PG, Rawal BD, Khayam-Bashi H, Vyas GN. Detection of exceedingly low levels of HIV proviral DNA in multimillion peripheral blood mononuclear cells by PCR. PCR Methods Appl. 1993;3:63-4.
11. Armbruster DA, Tillman MD, Hubbs LM. Limit of dectection (LQD)/limit of quantitation (LOQ): comparison of the empirical and statistical methods ex-emplified with GC-MS assays of abused drugs. Clin Chem. 1994;40:1233-8.
12. Saiki RK, Gelfand DH, Stoffel S, Scharf SJ, Higuchi R, Horn GT, et al. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science. 1988;239:487-91.
13. Ou CY, Kwok S, Mitchell SW, Mack DH, Sninsky JJ, Krebs JW, et al. DNA amplification for direct detection of HIV-1 in DNA of peripheral blood mononuclear cells. Science. 1988;239:295-7.
14. Rosenthal N. Tools of the trade - recombinant DNA. N Engl J Med. 1994; 331:315-7.
15. Nocton JJ, Dressler F, Rutledge BJ, Rys PN, Persing DH, Steere AC. Detection of Borrelia burgdorferi DNA by polymerase chain reaction in synovial fluid from patients with Lyme arthritis. N Engl J Med. 1994;330:229-34.
16. Horowitz HW, Valsamis MP, Wicher V, Abbruscato F, Larsen SA, Wormser GP, et al. Brief report: cerebral syphilitic gumma confirmed by the polymerase chain reaction in a man with human immunodeficiency virus infection. N Engl J Med. 1994;331:1488-91.
17. Tosswill JH, Barlow KL, Parry JV, Clewley JP. Polymerase chain reaction to diagnose HIV-1 [Letter]. Lancet. 1994;343:1431.
18. MacGregor RR, Dubin G, Frank I, Hodinka RL, Friedman HM. Failure of culture and polymerase chain reaction to detect human immunodeficiency virus (HIV) in seronegative steady sexual partners of HIV-infected individuals. Clin Infect Dis. 1995;21:122-7.
19. Gordon SM, Eaton ME, George R, Larsen S, Lukehart SA, Kuypers J, et al. The response of symptomatic neurosyphilis to high-dose intravenous penicillin G in patients with human immunodeficiency virus infection. N Engl J Med. 1994;331:1469-73.
20. Sanchez PJ, Wendel GD Jr, Grimprel E, Goldberg M, Hall M, Arencibia-Mireles O, et al. Evaluation of molecular methodologies and rabbit infectivity testing for the diagnosis of congenital syphilis and neonatal central nervous system invasion by Treponema pallidum. J Infect Dis. 1993;167:148-57.
21. Clewley JP. The polymerase chain reaction, a review of the practical limitations for human immunodeficiency virus diagnosis. J Virol Methods. 1989;25: 179-88.
22. Candotti D, Jung M, Kerouedan D, Rosenheim M, Gentilini M, M'Pele P, et al. Genetic variability affects the detection of HIV by polymerase chain reaction. AIDS. 1991;5:1003-7.
23. Yeni P. Viral load [Abstract]. In: The Status and Trends of the Global HIV/AIDS Pandemic, July 5-6, 1996 - Final Report. Vancouver: XI International Conference on AIDS; 1996.
24. Coutlee F, Viscidi RP, Saint-Antoine P, Kessous A, Yolken RH. The polymerase chain reaction: a new tool for the understanding and diagnosis of HIV-1 infection at the molecular level. Mol Cell Probes. 1991;5:241-59.
25. Owens DK, Holodniy M, Garber AM, Scott J, Sonnad S, Moses L, et al. Polymerase chain reaction for the diagnosis of HIV infection in adults. A meta-analysis with recommendations for clinical practice and study design. Ann Intern Med. 1996;124:803-15.
26. Noordhoek GT, Wolters EC, de Jonge ME, van Embden JD. Detection by polymerase chain reaction of Treponema pallidum DNA in cerebrospinal fluid from neurosyphilis patients before and after antibiotic treatment. J Clin Microbiol. 1991;29:1976-84.