HIV ANTIBODY TESTING WITH SALIVA  



back to Epidemiology Homepage

about Epidemiology and the department

Epidemiology academic information

Epidemiology faculty

Epidemilogy resources

sites of interest to Epidemiology professionals



© 1999

Last Updated

02 Nov 2002

DATED THROUGH 1996

The least expensive way to determine infection by the human immunodeficiency virus (HIV) is to test for the presence of HIV antibodies. Diagnostic testing is done in two stages, a screening test and a confirmatory test. The screening test is done on the initial submitted blood specimen, usually with an enzyme-linked immunoadsorbent assay (ELISA). If non-reactive for HIV antibodies, the screening test is termed negative and no further testing is done. If reactive or inconclusive for HIV-antibodies, the screening test is repeated but this time with a confirmatory test such as the Western blot, immunoflourescent assay (IFA), or two different ELISA. If the confirmatory test is positive, the person likely has been infected with the HIV virus. Because of the serious nature of this diagnosis and the possibilities of test or laboratory error, persons who are diagnosed HIV positive are typically asked to return at a later time for another independent diagnostic test.

In the United States, all persons who obtain the HIV test are expected to be counseled, both before the blood specimen is collected and after the results are known. The cost of such testing is high, usually ranging from about $50-75 for a negative test sequence to $150-175 for a positive test sequence. At federally-funded HIV testing centers in the United States, more than 95 percent of persons receiving blood tests are found to be negative. Thus the majority of funds spent by the US government for HIV testing goes to counseling and testing of uninfected persons.

An alternative to blood testing is to use saliva which also contains HIV antibodies, but at lower concentrations. Many investigators have studied and evaluated saliva tests and found them to be almost as valid as blood tests. Validity is measured by sensitivity, the percentage that measures positive with the test among those who truly have HIV antibodies, and specificity, the percentage that measures negative with the test among those who truly do not have HIV antibodies.

Saliva tests have been recommended and used for population surveys, surveillance programs, and personal screening. The test would be especially useful for screening since the saliva specimen could be collected in the privacy of the home, shipped to a laboratory and the results heard over the telephone. If the screening test is positive, the person would be referred to a health care provider for counseling and diagnostic testing with blood. With such a system, the percentage of persons at testing centers who are HIV negative would be greatly decreased, allowing more time and effort to be spent on those truly infected with the deadly virus. Such personal screening programs, however, are not yet legal in the United States because saliva tests for home use have not been licensed by the Food and Drug Administration (FDA).

A summary of all publications on saliva tests that have appeared to 1996 is shown below in Table 1.


HIV antibodies in blood (i.e., HIV+)

Yes

No

Saliva test

+

A

B

-

C

D

Sensitivity (%) = 

[A/(A+C)] x 100

Specificity (%) = 

[D/(B+D)] x 100


  

Table 1.Published studies of HIV antibody assays using saliva, 1987-96.

Collection method

HIV antibody assay

Number of Subjects

Sensitivity

Specificity

Authors

HIV+

HIV-

(%)

(%)

Parry et al, 19871

Free drip 

GACELISA

43

10

100.0

100.0

Free drip

GACRIA

41

10

100.0

100.0

Johnson et al, 19882

Free drip

GACRIA

196

460

100.0

99.8

Free drip

Wellcome ELISA

165

405

90.9

99.8

Free drip

Abbott ELISA

184

443

82.1

100.0

Free drip

Fujirebio PA

179

421

97.8

84.1

Holmstrom et al, 19903

Stimulated drip

Vironostika ELISA

36

14

97.2

100.0

O'Shea et al, 19904

Mouth wash

Abbott ELISA

22

--

90.0

--

Archibald et al, 19915

Free drip

ASQ ELISA

21

--

95.2

--

Behets et al, 19916

Free drip

Vironostika ELISA

145

313

97.9

100.0

Major et al, 19917

Not stated

Cambridge ELISA

119

429

98.3

100.0

Crofts et al, 19918

Salivette

GACELISA

50

50

98.0

100.0

Salivette

Abbott ELISA

50

50

88.0

100.0

Coates et al, 19919

Free drip

Cambridge EIA

11

323

100.0

100.0

Klokke et al, 199110

Not stated

GACELISA

42

48

100.0

100.0

Van den Akker et al, 199211

Free drip

Vironostika ELISA

79

115

100.0

100.0

Gershy-Damet et al, 199212

Free drip

GACELISA

32

43

100.0

97.7

Soto-Ramirez et al, 199213

Orasure

Organon Teknika ELISA

356

1,524

99.4

100.0

Frerichs et al, 199214

Omni-Sal

Cambridge EIA (Myanmar)

74

401

90.5

99.5

Omni-Sal

Cambridge EIA (USA)

74

400

94.6

99.5

Omni-Sal

Cambridge EIA (Myanmar)

--

1,025

--

100.0

Omni-Sal

Cambridge EIA (USA)

--

1,025

--

100.0

Thongcharoen et al, 199215

Free drip

GACELISA

54

55

100.0

100.0

Covell et al, 199316

Salivette

GACELISA

4

94

100.0

100.0

Hunt et al, 199317

Cotton swab

GACELISA

8

214

100.0

100.0

Cotton swab

GACRIA

18

273

94.4

100.0

Connell et al, 199318

Salivette

GACELISA

50

127

100.0

100.0

Chamnanput et al, 199319

Free drip

DB ELISA HIV-1

100

100

94.4

89.0

Free drip

Genelavia HIV-1/HIV-2

100

100

96.6

100.0

Free drip

Abbott HIV-1/HIV-2 EIA

100

100

99.0

100.0

Free drip

Abbott Testpack HIV-1/HIV-2

100

100

100.0

100.0

Free drip

Recombigen HIV-1/HIV-2 RTD

100

100

100.0

100.0

Holm-Hansen et al, 199320

Orasure

Abbott EIA

41

244

92.7

100.0

Orasure

Abbott Testpack

44

243

100.0

100.0

Orasure

Murex SUDS-1

36

230

97.2

100.0

Urguia et al, 199321

Not stated

Sandwich indirect immumunoassay

50

50

96.0

100.0

Frerichs et al, 199422

Omni-Sal

GACELISA

75

1,405

100.0

99.9

Omni-Sal

Cambridge EIA

75

1,405

93.3

99.9

Omni-Sal

Abbott HIVAB EIA

75

1,405

98.7

99.1

Chassany et al, 199423

Omni-Sal

GACELISA

115

451

100.0

100.0

Frerichs et al, 199424

Omni-Sal

GACELISA

300

1,654

100.0

99.6

Lu et al. 199425

Omni-Sal

Abbott EIA

57

52

100.0

100.0

Omni-Sal

Abbott Test Pack

57

52

100.0

100.0

King et al, 199526

Omni-Sal

Cambridge EIA

368

888

97.3

100.0

Emmons et al, 199527

Orasure

Abbott HIVAB EIA

195

198

100.0

100.0

Luo N et al, 199528

Free drip

GACELISA

50

57

98.0

100.0

Free drip

Wellcozyme HIV-1

50

57

96.0

100.0

Free drip

Wellcozyme HIV 1/2

50

57

94.0

100.0

Vall Mayans et al, 199529

Omni-Sal

GACELISA

133

153

100.0

98.7

Martinez et al, 199530

Salivette

GACELISA

104

137

100.0

81.8

Salivette

Abbott Test Pack

103

137

100.0

100.0

Wongba et al, 199531

Omni-Sal

Detect HIV 1/2

172

814

97.7

100.0

Ishikawa et al, 199532

Free drip

Immune complex transfer EIA

63

76

100.0

100.0

Granade et al, 199533

Omni-Sal

Abott 3A11 EIA

149

136

100.0

99.3

Omni-Sal

GACELISA

149

136

100.0

99.3

del Rio et al, 199634

Orasure

Abbott Recombinant

137

366

98.5

100.0

REFERENCES

1. Parry JV, Perry KR, Mortimer PP. Sensitive assays for viral antibodies in saliva: an alternative to tests on serum. Lancet 1987; 335:72-75.

2. Johnson AM, Parry JV, Best SJ, Smith AMA, Mortimer PP. HIV surveillance by testing saliva. Aids 1988; 2(5):369-371.

3. Holmstrom P, Syrjanen S, Laine P, Valle SL, Suni J. HIV antibodies in whole saliva detected by ELISA and western blot assays. Journal of Medical Virology 1990; 30(4):245-248.

4. O'Shea S, Cordery M, Barrett WY, Richman DD, Bradbeer C, Banatvala JE. HIV excretion patterns and specific antibody responses in body fluids. Journal of Medical Virology 1993; 31(4):291-296.

5. Archibald DW, Hebert CA. Salivary detection of HIV-1 antibodies using recombinant HIV-1 peptides. Viral Immunology 1991; 4(1):17-22.

6. Behets F, Edidi B, Quinn TC, Atikala L, Bishagara K, Nzila N, et al. Detection of salivary HIV-1-specific IgG antibodies in high-risk populations in Zaire. Journal of Acquired Immune Deficiency Syndromes 1991; 4(2):183-187.

7. Major CJ, Read SE, Coates RA, Francis A, McLaughlin BJ, Millson M, et al. Comparison of saliva and blood for human immunodeficiency virus prevalence testing. Journal of Infectious Diseases 1991; 163(4):699-702.

8. Crofts N, Nicholson S, Coghlan P, Gust ID. Testing of saliva for antibodies to HIV-1. Aids 1991; 5(5):561-563.

9. Coates R, Millson M, Myers T, Rankin J, McLaughlin B, Major C, et al. The benefits of HIV antibody testing of saliva in field research. Canadian Journal of Public Health 1991; 82(6):397-398.

10. Klokke AH, Ocheng D, Kalluvya SE, Nicoll AG, Laukamm-Josten U, Parry JV, et al. Field evaluation of immunoglobulin G antibody capture tests for HIV-1 and HIV-2 antibodies in African serum, saliva and urine [letter]. Aids 1991; 5(11):1391-1392.

11. van den Akker R, van den Hoek JA, van den Akker WM, Kooy H, Vijge E, Roosendaal G, et al. Detection of HIV antibodies in saliva as a tool for epidemiological studies. Aids 1992; 6(9):953-957.

12. Gershy-Damet GM, Koffi K, Abouya L, Sasson-Morokro M, Brattegaard K, Parry JV, et al. Salivary and urinary diagnosis of human immunodeficiency viruses 1 and 2 infection in Cote d'Ivoire, using two assays. Transactions of the Royal Society of Tropical Medicine and Hygiene 1992; 86(6):670-671.

13. Soto-Ramirez LE, Hernandez-Gomez L, Sifuentes-Osornio J, Barriga-Angulo G, Duarte de Lima D, Lopez-Portillo M, et al. Detection of specific antibodies in gingival crevicular transudate by enzyme-linked immunosorbent assay for diagnosis of human immunodeficiency virus type 1 infection. Journal of Clinical Microbiology 1992; 30:2780-2783.

14. Frerichs RR, Htoon MT, Eskes N, Lwin S. Comparison of saliva and serum for HIV surveillance in developing countries. Lancet 1992; 340:1496-1499.

15. Thongcharoen P, Wasi C, Louisirirotchanakul S, Parry J, Connell J, Mortimer P. Immunoglobulin G antibody capture enzyme-linked immunosorbent assay: a versatile assay for detection of anti-human immunodeficiency virus type 1and 2 antibodies in body fluids. Journal of Clinical Microbiology 1992; 30(12):3288-3289.

16. Covell R, Follett E, Coote I, Bloor M, Finlay A, Frischer M, et al. HIV testing among injecting drug users in Glasgow. Journal of Infection 1993; 26(1):27-31.

17. Hunt AJ, Connell J, Christofinis G, Parry JV, Weatherburn P, Hickson FC, et al. The testing of saliva samples for HIV-1 antibodies: reliability in anon-clinic setting. Genitourinary Medicine 1993; 69(1):29-30.

18. Connell JA, Parry JV, Mortimer PP, Duncan J. Novel assay for the detection of Immunoglobulin G anti-human immunodeficiency virus in untreated saliva and urine. Journal of Medical Virology 1993; 41:159-164.

19. Chamnanput J, Phanuphak P. Comparison of eight commercial test kits for detecting anti-HIV antibodies in saliva specimens [letter]. Aids 1993; 7(7):1026

20. 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. Clinical and Diagnostic Virology 1993; 1(3):207-214.

21. Urquia M, Rodriguez-Archilla A, Gonzalez-Moles MA, Ceballos A. Detection of anti-HIV antibodies in saliva. Journal of Oral Pathology and Medicine 1993; 22(4):153-156.

22. Frerichs RR, Eskes N, Htoon MT. Validity of three saliva assays for HIV-antibodies. Journal of Acquired Immune Deficiency Syndromes 1994; 7(5):522-524.

23. Chassany O, Bergmann JF, Mazeron MC, Cervoni J, Gregoire V, Sanson-Le-Pors MJ, et al. Testing of anti-HIV antibodies in saliva. Aids 1994; 8(5):713

24. Frerichs RR, Silarug N, Eskes N, Pagcharoenpol P, Rodklai A, Thangsupachai S, et al. Saliva-based HIV antibody testing in Thailand. Aids 1994; 8:885-894.

25. Lu XS, Delfraissy JF, Grangeot-Keros L, Rannou MT, Pillot J. Rapid and constant detection of HIV antibody response in saliva of HIV-infected patients; selective distribution of anti-HIV activity in the IgG isotype. Research in Virology 1994; 145:369-377.

26. King A, Marion SA, Cook D, Rekart M, Middleton PJ, O'Shaughnessy MV, et al. Accuracy of a saliva test for HIV antibody. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1995; 9:172-175.

27. Emmons WW, Paparello SF, Decker CF, Sheffield JM, Lowe-Bey FH. A modified ELISA and western blot accurately determine anti-human immunodeficiency virus type 1 antibodies in oral fluids obtained with a special collecting device. Journal of Infectious Diseases 1995; 171:1406-1410.

28. Luo N, Kasolo F, Ngwenya BK, du Pont HL, Zumla A. Use of saliva as an alternative to serum for HIV screening in Africa. South African Medical Journal 1995; 85:156-157.

29. Vall Mayans M, Casabona J, Rabella N, De Miniac D. Comparison of saliva and serum for HIV testing among populations with high risk behaviors. European J Clinical Microbiology and Infectious Diseases 1995; 14:710-713.

30. Martinez P, Ortiz de Lejarazu R, Eiros JM, Perlado E, Flores M, del Pozo MA, et al. Comparison of two assays for detection of HIV antibodies in saliva. European J Clinical Microbiology and Infectious Diseases 1995; 14:330-336.

31. Wongba C, Pagcharoenpol P, Eskes N, Frerichs RR, Silarug N. HIV saliva test for surveillance and surveys. Aids 1995; 9:1104-1105.

32. Ishikawa S, Hashida S, Hashinaka K, Hirota K, Saitoh A, Takamizawa A, et al. Diagnosis of HIV-1 infection with whole saliva by detection of antibody IgG to HIV-1 with ultrasensitive enzyme immunoassay using recombinant reverse transcriptase as antigen. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1995; 10:41-47.

33.Granade TC, Phillips SK, Parekh B, Pau CP, and George JR. Oral fluid as a specimen for detection and confirmation of antibodies to human immunodeficiency virus type 1. Clinical and Diagnostic Laboratory Immunology 1995; 2(4):395-399.

34. C.del Rio J, Guarner J, Izazola-Licea JA. The use of oral fluid to determine HIV-1 prevalence rates among men in Mexico City. Aids 1996; 10:233-235.