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. 1998 Dec 7;11(1):63–68. doi: 10.1002/(SICI)1098-2825(1997)11:1<63::AID-JCLA10>3.0.CO;2-N

Evaluation of two novel immunoassays designed to detect HIV antibodies in oral fluids

Rebecca D Saville 1, Niel T Constantine 2,✉, Carol Holm‐Hansen 3, Christine Wisnom 1, Louis DePaola 1, William A Falkler Jr 1
PMCID: PMC6760747  PMID: 9021526

Abstract

The testing of oral fluid samples for the detection of HIV antibodies offers several advantages over the testing of blood. Our objective was to evaluate a new generation of rapid and simple assays designed specifically to detect HIV‐1 and HIV‐2 antibodies in oral fluids (saliva). Serum and oral fluid pairs were collected from 615 high‐ and low‐risk individuals in the United States, Peru, and the Ivory Coast. Two different oral fluid collection devices and rapid assay systems included: (1) the Orapette/SalivaCard HIV‐1/HIV‐2 and (2) the Omni‐Sal/ImmunoComb II HIV‐1 and HIV‐2. The corresponding serum pairs were analyzed by conventional ELISAs, and all reactive sera were confirmed with HIV‐1 and HIV‐2 Western blots. The results indicated a 100% sensitivity for both rapid oral fluid assays, including successful detection of HIV‐2 antibodies. Specificities ranged from 99.8% to 100%. One sample produced a reactive result by the SalivaCard while being nonreactive by the other assays including the Western blots. Both assays performed excellently, indicating that antibodies to HIV can be detected reliably in oral fluids by simple and rapid assays. This combination of rapid testing technology and the use of easily collected oral fluid samples offers an efficient and accurate alternative to conventional testing and can be appropriately applied to a variety of testing situations for the laboratory diagnosis of HIV infection. J. Clin. Lab. Anal. 11:63–68. © 1997 Wiley‐Liss, Inc.

Keywords: rapid assays, saliva, diagnosis, retroviruses, serology

References

  • 1. Constantine NT: HIV testing revisited. Advance May:16, 1995.
  • 2. Johnson A, Parry JV, Best SJ, Smith AM, de Silva M, Mortimer P: HIV surveillance by testing saliva. AIDS 2: 369–371, 1988. [DOI] [PubMed] [Google Scholar]
  • 3. O'Shea S, Cordery M, Barrett Y, Richman DD, Bradbeer C, Banatvala JE: HIV excretion patterns and specific antibody responses in body fluids. J Med Virol 31: 291–296, 1990. [DOI] [PubMed] [Google Scholar]
  • 4. Crofts N, Nicholson S, Coghlan P, Gust ID: Testing of saliva for antibodies to HIV‐1. AIDS 5: 561–563, 1991. [PubMed] [Google Scholar]
  • 5. Archibald DW, Hebert CA: Salivary detection of HIV‐1 antibodies using recombinant HIV‐1 peptides. Viral Immunol 4: 17–22, 1991. [DOI] [PubMed] [Google Scholar]
  • 6. Parry JV, Perry KR, Mortimer PP: Sensitive assays for viral antibodies in saliva: An alternative to tests on serum. Lancet 2: 72–75, 1987. [DOI] [PubMed] [Google Scholar]
  • 7. Tamashiro H, Constantine NT: Serological diagnosis of HIV infection using oral fluid samples. Bull World Health Organ 72(1): 135–143, 1994. [PMC free article] [PubMed] [Google Scholar]
  • 8. Lehner T: Saliva and gingival crevicular fluid In: Immunology of Oral Disease, 3 rd ed. Blackwell, Oxford, 1992. [Google Scholar]
  • 9. Roitt IM, Lehner T: Oral immunity In: Immunology of Oral Diseases, 2 nd ed. Blackwell, Oxford, 1983. [Google Scholar]
  • 10. Tamashiro H, Maskill W, Emmanuel J, Fauquex A, Sato P, Heymann D: Reducing the cost of HIV antibody testing. Lancet 342: 87–90, 1993. [DOI] [PubMed] [Google Scholar]
  • 11. Piacentini SC, Thieme TR, Beller M, Davidson SL: Diagnosis of hepatitis A, B, and C using oral samples. Annals NY Acad Sci 694: 334–336, 1993. [DOI] [PubMed] [Google Scholar]
  • 12. Parry JV: Detection of viral antibodies in saliva specimens as an alternative to serum. J Clin Chem Clin Biochem 27: 245–249, 1989. [PubMed] [Google Scholar]
  • 13. Mandel ID: Salivary diagnosis: Promises, promises. Ann NY Acad Sci 694: 1–10, 1993. [DOI] [PubMed] [Google Scholar]
  • 14. Constantine NT, Callahan JD, Watts DM: Retroviral testing: Essentials for quality control and laboratory diagnosis. CRC Press, Boca Raton, 1992. [Google Scholar]
  • 15. Goodman DB: Fundamental principles involved in developing a new saliva‐based diagnostic test. Ann NY Acad Sci 694: 78–85, 1993. [DOI] [PubMed] [Google Scholar]
  • 16. World Health Organization , Global Programme on AIDS: Recommendations for the selection and use of HIV antibody tests. Wkly Epidemiol Rec 61: 145–152, 1992. [PubMed] [Google Scholar]
  • 17. Frerichs RR, Htoon MT, Eskes N, Lwin S: Comparison of saliva and serum for HIV surveillance in developing countries. Lancet 340: 1496–1499, 1992. [DOI] [PubMed] [Google Scholar]
  • 18. Holm‐Hansen C, Constantine NT, Haukenes G: Detection of antibodies to HIV in homologous sets of plasma, urine and oral mucosal transudate samples using rapid assays in Tanzania. Clin Diag Virol 1: 207–214, 1993. [DOI] [PubMed] [Google Scholar]
  • 19. Covell R, Follett E, Coote I, Bloor M, Finlay A, Frischer M, Goldberg D, Green S, Haw S, McKeganey N: HIV testing among injecting drug users in Glasgow. J Inf 26: 27–31, 1993. [DOI] [PubMed] [Google Scholar]
  • 20. Gitzgibbons D, Barriga G, Seymour E, Stramer S: HIV antibody EIA and Western blot assay results on paired serum and saliva specimens. Ann NT Acad Sci 694: 314–316, 1993. [DOI] [PubMed] [Google Scholar]
  • 21. Connell JA, Parry JV, Mortimer PP, Duncan J: Novel assay for the detection of immunoglobulin G antihuman immunodeficiency virus in untreated saliva and urine. J Med Virol 41: 159–164, 1993. [DOI] [PubMed] [Google Scholar]
  • 22. Chamnanput J, Phanuphak: Comparison of eight commercial test kits for detecting anti‐HIV antibodies in saliva specimens. AIDS 7: 1026, 1993. [DOI] [PubMed] [Google Scholar]
  • 23. Stark K, Warnecke C, Brinkman V, Gelderblom HR, Bienzle U, Pauli G: Sensitivity of HIV antibody detection in saliva. Med Microbiol Immunol 182: 147–151, 1993. [DOI] [PubMed] [Google Scholar]
  • 24. Hunt AJ, Connell J, Christofinis G, Parry JV, Weatherburn P, Hickson FCI, Coxon APM, Davies PM, McManus TJ, Sutherland S: The testing of saliva samples for HIV‐1 antibodies: Reliability in a non‐clinic setting. Genitourin Med 69: 29–30, 1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 25. Chassany O, Vbergman JF, Mazeron MC, Cervoni J, Gregoire V, Sanson‐Le‐Pors, Caulin C: Testing of anti‐HIV antibodies in saliva. AIDS 8: 713–714, 1994. [DOI] [PubMed] [Google Scholar]
  • 26. de Pilar Azinheira M, Santos Pinto A, Prieto E, Albuquerque R, Cana Ferreira W: Detection of antibodies to HIV‐2 in the saliva of HIV‐2 seropositive subjects. AIDS 8: 849–859, 1994. [DOI] [PubMed] [Google Scholar]
  • 27. Frerichs RR, Eskes N, Htoon MT: Validity of three assays for HIV‐1 antibodies in saliva. J Acquired Immune Defic Syndr 7: 522–525, 1994. [PubMed] [Google Scholar]
  • 28. Frerichs RR, Silarug N, Eskes N, Pagcharoenpol P, Rodklai A, Thangsupachai S, Wongba C: Saliva‐based HIV‐antibody testing in Thailand. AIDS 8: 855–894, 1994. [DOI] [PubMed] [Google Scholar]
  • 29. Fernandez RE, Carcaba FV, Rodrigues JM, Alfonso J, Garcia AZ, Garcia AS: Deteccion de anticuerpos anti‐VIH en saliva con un enzimoinmunoensayo de diagnotico rapido. Rev Clin Esp 194: 523–525, 1994. [PubMed] [Google Scholar]
  • 30. Lu XS, Delfraissy JF, Grangeot‐Keros L, Rannou MT, Pillot J: Rapid and constant detection of HIV antibody response in saliva on HIV‐infected patients. Selective distribution of anti‐HIV activity in the IgG isotype. Res Virol 145: 369–377, 1994. [DOI] [PubMed] [Google Scholar]
  • 31. Emmons WW, Paparello SG, Decker CF, Sheffield JM, Lowe‐Bey FH: A modified ELISA and Western blot accurately determine anti‐HIV‐1 antibodies in oral fluids obtained with a special collecting device. J Infect Dis 171: 1406–1410, 1995. [DOI] [PubMed] [Google Scholar]
  • 32. Granade TC, Phillips SK, Parekh B, Pau C, George JR: Oral fluid as a specimen for detection and confirmation of antibodies to human immunodeficiency virus type 1. Clin Diag Lab Immunol 2: 395–399, 1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 33. Behets FM, Edidi B, Quinn TC, Atikala L, Bishagara K, Nzila N, Laga M, Piot P, Ryder RW, Brown CC: Detection of salivary HIV‐1 specific IgG antibodies in high‐risk populations in Zaire. J Acquired Immune Defic Syndr 4: 183–187, 1991. [PubMed] [Google Scholar]
  • 34. Bradtzaeg P, Fjellanger I, Gjeruldsen ST: Human secretory immunoglobulins. Scand J Haematol 12(suppl): 1–83, 1970. [PubMed] [Google Scholar]
  • 35. van den Akker R, van den Hoek AR, van den Akker WMR, Kooy H, Vijge E, Roosendaal G, Coutinho A, van Loon AM: Detection of HIV antibodies in saliva as a tool for epidemiological studies. AIDS 6: 953–957, 1992. [DOI] [PubMed] [Google Scholar]
  • 36. Soto‐Ramirez LE, Hernandez‐Gomez L, Sifuentes‐Osornio J, Barriga‐Angulo G, De Lima DD, Lopez‐Portillo M, Ruiz‐Palacios GM: Detection of specific antibodies in gingival crevicular transudate by enzyme‐linked immunosorbent assay for diagnosis of human immunodeficiency virus type 1 infection. J Clin Microbiol 30: 2780–2783, 1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 37. Barriga G, Castillo P, Seymour E, Stramer SL: Use of a rapid test for the determination of salivary HIV‐l/HIV‐2 antibodies. 7th Int Conf AIDS [Abstract PoB 3602], 1992.
  • 38. Major CJ, Read SE, Coates RA, Francis A, McLaughlin BJ, Millson M, Shepherd F, Fanning M, Calzavara L, MacFadden D, Johnson JK, O'Shaughnessy MV: Comparison of saliva and blood for human immunodeficiency virus prevalence testing. J Infec Dis 163: 699–702, 1991. [DOI] [PubMed] [Google Scholar]
  • 39. Constantine NT, Holm‐Hansen C, Nilsen R: Rapid testing for HIV antibodies in Tanzania: The use of a novel collection/testing system for detection in serum and saliva. 3rd Taipei Int AIDS Conf, Taipei: Abstract [12], 1994.
  • 40. Cheingsong‐Popov R, Callow D, Weber J, Holm‐Hansen C, Constantine NT: Antibody to specific HIV‐1 proteins in oral mucosal transudates. Lancet 341: 1659–1660, 1993. [DOI] [PubMed] [Google Scholar]
  • 41. Thongcharoen P, Wasi C, Louisirirotchanakul S, Parry J, Connell J, Mortimer PP: Immunoglobulin G antibody capture enzyme‐linked immunosorbent assay: A versatile assay for detection of anti‐human immunodeficiency virus type 1 and 2 antibodies in body fluids. J Clin Microbiol 30: 388–3289, 1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 42. Gershy‐Damet GM, Koffi K, Abouya L, Sasson‐Morokro M, Brattegaard K, Parry JV, DeCock KM, Mortimer PP: Salivary and urinary diagnosis of human immunodeficiency 1 and 2 infection in Cote d'Ivoire using two assays. Trans R Sco Trop Med Hyg 86: 670–671, 1992. [DOI] [PubMed] [Google Scholar]
  • 43. Constantine NT, Callahan JD, Campos P, Sanchez J, Wooster MT, Watts DM: Saliva testing for HIV‐1/2 in Lima: Encouraging results using a special collection device and two rapid assays. 9th Int Conf Microbiol Parisitol, Lima, Abstract [V‐GA039], 1994.
  • 44. European Working Group on HIV infection in Female Prostitutes : HIV infection in European female sex workers: Epidemiological link with the use of petroleum‐based lubricants. AIDS 7: 401–408, 1993. [PubMed] [Google Scholar]
  • 45. Parry JV: Simple and reliable salivary tests for HIV and Hepatitis A and B virus diagnosis and surveillance. Ann NY Acad Sci 694: 216–233, 1993. [DOI] [PubMed] [Google Scholar]
  • 46. Turnbull PJ, Stimson GV, Dolan KA: Prevalence of HIV infection among ex‐prisoners in England. BMJ 304: 90–91, 1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 47. Urquia M, Rodriguez‐Archilla A, Gonzales‐Moles MA, Ceballos A: Detection of anti‐HIV antibodies in saliva. J Oral Pathol Med 22: 153–156, 1993. [DOI] [PubMed] [Google Scholar]
  • 48. Coates R, Millson M, Myers T, Rankin J, McLaughlin B, Major C, Rigby J, Mindell W: The benefits of HIV antibody testing of saliva in field research. Can J Public Health 82: 397–398, 1991. [PubMed] [Google Scholar]
  • 49. Levy JA: HIV and the Pathogenesis of AIDS. ASM Press, Washington, DC, 1994. [Google Scholar]
  • 50. Constantine NT: Serologic tests for the retroviruses: Approaching a decade of evolution. AIDS 7: 1–13, 1993. [DOI] [PubMed] [Google Scholar]

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