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May 1, 1996, Vol 275, No. 17 >
ARTICLE | May 1, 1996

A Meta-analytic Evaluation of the Polymerase Chain Reaction for the Diagnosis of HIV Infection in Infants FREE

Douglas K. Owens, MD, MSc; Mark Holodniy, MD; Thomas W. McDonald, MD; John Scott; Seema Sonnad, MS
[+] Author Affiliations

Reprints: Douglas K. Owens, MD, MSc, Section of General Internal Medicine (111 A), VA Palo Alto Health Care System, 3801 Miranda Ave, Palo Alto, CA 94304.


JAMA. 1996;275(17):1342-1348. doi:10.1001/jama.1996.03530410056034
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Published online
Article
References

Objective.  —To evaluate the sensitivity and specificity of the polymerase chain reaction (PCR) for the diagnosis of infection with human immunodeficiency virus (HIV) in infants.

Data Sources.  —We used studies published between 1988 and 1994 identified in a literature search of 17 databases, including MEDLINE.

Study Selection.  —Studies were included if DNA amplification by PCR was performed on peripheral blood mononuclear cells from infants or children.

Data Extraction.  —Two investigators independently extracted data. The study design was assessed independently by 2 investigators who were blinded to study results.

Data Synthesis.  —Thirty-two studies met the inclusion criteria and were analyzed. The median reported sensitivity was 91.6% (range, 31%-100%), and the median specificity was 100% (range, 50%-100%). A summary receiver operating characteristic curve based on all 32 studies indicated that PCR has a maximum joint sensitivity and specificity between 93.2% and 94.9%. Subgroup analysis indicated that the joint sensitivity and specificity was significantly (P=.04) higher in older infants (98.2%) than in neonates (aged ≤30 days; 93.3%). For infants at low risk of perinatal transmission (probability of transmission, 8.3%), the positive predictive value for PCR is 55.8% in neonates and 83.2% in older infants. A negative PCR result reduces the probability of HIV infection to less than 3%. No studies met all criteria for study design.

Conclusions.  —Although PCR is one of the best available tests for diagnosis of HIV infection in neonates and infants, it is not definitive. Therefore, PCR should be interpreted with the aid of careful clinical follow-up examinations. The sensitivity and specificity of PCR in neonates is lower than in older infants, which results in a low positive predictive value; however, negative tests are informative. Delaying the use of PCR until after the neonatal period or repeating PCR on independent samples obtained 30 to 60 days later will reduce test errors.(JAMA. 1996;275:1342-1348)

REFERENCES

1 +
Ryder R, Hassig S.  The epidemiology of perinatal transmission of HIV. AIDS . 1988;;2( (suppl 1) ): S83-S89.
2 +
Ryder RW, Nsa W, Hassig SE, et al.  Perinatal transmission of the human immunodeficiency virus type 1 to infants of seropositive women in Zaire. N Engl J Med . 1989;;320:1637-1642.
3 +
Mok J, Giaquinto C, De Rossi A, Grosch-Wörner I, Ades A, Peckham C.  Infants born to HIV seropositive mothers: preliminary findings from a multi-centre European study. Lancet . 1987;;1:1164-1168.
4 +
European Collaborative Study.  Mother-to-child transmission of HIV infection. Lancet . 1988;;2:1039-1042.
5 +
Blanche S, Rouzioux C, Guihard-Moscato ML, et al, for the HIV Infection in Newborns French Collaborative Study Group.  A prospective study of infants born to women seropositive for human immunodeficiency virus type 1. N Engl J Med . 1989;; 320:1643-1648.
6 +
Connor EM, Sperling RS, Gelber R, et al.  Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment: Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med . 1994;; 331:1173-1180.
7 +
World Health Organization, Global Program on AIDS. The HIV/AIDS Pandemic: 1994 Overview . Geneva, Switzerland: World Health Organization; 1994;:13. Available from Pan American Health Organization, 525 23rd St NW, Washington, DC 20037.
8 +
Centers for Disease Control.  Classification system for human immunodeficiency virus (HIV) infection in children under 13 years of age. MMWR Morb Mortal Wkly Rep . 1987;;36:225-236.
9 +
Centers for Disease Control and Prevention.  1994 revised classification system for human immunodeficiency virus infection in children less than 13 years of age. MMWR Morb Mortal Wkly Rep . 1994;; 43:1-9.
10 +
El-Sadr W, Oleske JM, Agins BD, et al. Evaluation and Management of Early HIV Infection: Clinical Practice Guideline No. 7 . Rockville, Md: Agency for Health Care Policy and Research, Public Health Service, US Dept of Health and Human Services; January 1994;. Agency for Health Care Policy and Research publication 94-0572.
11 +
Rogers MF, Ou CY, Rayfield M, et al, for the New York City Collaborative Study of Maternal HIV Transmission and Montefiore Medical Center HIV Perinatal Transmission Study Groups.  Use of the polymerase chain reaction for early detection of the proviral sequences of human immunodeficiency virus in infants born to seropositive mothers. N Engl J Med . 1989;;320:1649-1654.
12 +
Escaich S, Wallon M, Baginski I, et al.  Comparison of HIV detection by virus isolation in lymphocyte cultures and molecular amplification of HIV DNA and RNA by PCR in offspring of seropositive mothers. J Acquir Immune Defic Syndr . 1991;;4: 130-135.
13 +
Fleiss J. Statistical Methods for Rates and Proportions . 2nd ed. New York, NY: John Wiley & Sons Inc; 1981;:13-17.
14 +
Moses L. Think and Explain With Statistics . Reading, Mass: Addison-Wesley Publishing Co; 1986;:250.
15 +
Owens DK, Holodniy M, Garber AM, et al.  The polymerase chain reaction for diagnosis of human immunodeficiency virus (HIV) infection in adults: a meta-analysis with recommendations for clinical practice and study design. Ann Intern Med . 1996;; 124:803-815.
16 +
Moses LE, Littenberg B, Shapiro D.  Combining independent studies of a diagnostic test into a summary ROC curve: data-analytic approaches and some additional considerations. Stat Med . 1993;;12: 1293-1316.
17 +
Kelsey J, Thompson W, Evans A. Methods in Observational Epidemiology . New York, NY: Oxford University Press; 1986;:366.
18 +
Robins J, Breslow N, Greenland S.  Estimators of the Mantel-Haenszel variance consistent in both sparse data and large strata-limiting models. Biometrics . 1986;;42:311-323.
19 +
Kent D, Haynor D, Larson E, Deyo R.  Diagnosis of lumbar spinal stenosis in adults: a meta-analysis of the accuracy of CT, MRI, and myelography. AJR Am J Roentgenol . 1992;;158:1135-1144.
20 +
Kent D, Larson E.  Disease, level of impact, and quality of research methods: three dimensions of clinical efficacy assessment applied to magnetic resonance imaging. Invest Radiol . 1992;;27:245-254.
21 +
Hoffman R, Kent D, Deyo R.  Meta-analysis of thermography for lumbar radiculopathy. Spine . 1991;;16:623-628.
22 +
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23 +
Arkin CF, Wachtel MS.  How many patients are necessary to assess test performance? JAMA . 1990;; 263:275-278.
24 +
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25 +
Philbrick JT, Horwitz RI, Feinstein AR.  Methodologic problem in exercise testing for coronary artery disease: groups, analysis and bias. Am J Cardiol . 1980;;46:807-812.
26 +
Ransohoff DF, Feinstein AR.  Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med . 1978;;299:926-930.
27 +
Schwartz JS, Dans PE, Kinosian BP.  Human immunodeficiency virus test evaluation, performance, and use: proposals to make good tests better. JAMA . 1988;;259:2574-2579.
28 +
Borghi V, Lami G, Frigieri G, et al.  Polymerase chain reaction in the early diagnosis of HIV-1 infection in high risk subjects. Microbiologica . 1993;; 16:181-184.
29 +
Borkowsky W, Krasinski K, Pollack H, Hoover W, Kaul A, Ilmet-Moore T.  Early diagnosis of human immunodeficiency virus infection in children <6 months of age: comparison of polymerase chain reaction, culture, and plasma antigen capture techniques. J Infect Dis . 1992;;166:616-619.
30 +
Brandt C, Rakusan T, Sison A, et al.  Detection of human immunodeficiency virus type 1 infection in young pediatric patients by using polymerase chain reaction and biotinylated probes. J Clin Microbiol . 1992;;30:36-40.
31 +
Brandt CD, Rakusan TA, Sison AV, Saxena ES, Ellaurie M, Sever JL.  Human immunodeficiency virus infection in infants during the first 2 months of life: reliable detection and evidence of in utero transmission. Arch Pediatr Adolesc Med . 1994;;148: 250-254.
32 +
Cassol SA, Lapointe N, Salas T, et al.  Diagnosis of vertical HIV-1 transmission using the polymerase chain reaction and dried blood spot specimens. J Acquir Immune Defic Syndr . 1992;;5:113-119.
33 +
Comeau AM, Hsu HW, Schwerzler M, Mushinsky G, Grady GF.  Detection of HIV in specimens from newborn screening programs. N Engl J Med . 1992;;326:1703.
34 +
Comeau AM, Harris JA, McIntosh K, Weiblen BJ, Hoff R, Grady GF.  Polymerase chain reaction in detecting HIV infection among seropositive infants: relation to clinical status and age and to results of other assays. J Acquir Immune Defic Syndr . 1992;;5:271-278.
35 +
De Rossi A, Ometto L, Mammano F, Zanotto C, Giaquinto C, Chieco-Bianchi L.  Vertical transmission of HIV-1: lack of detectable virus in peripheral blood cells of infected children at birth. AIDS . 1992;; 6:1117-1120.
36 +
Denamur E, Levine M, Simon F, et al.  Conversion of HIV-1 viral markers during the first few months of life in HIV-infected children born to seropositive mothers. AIDS . 1993;;7:897-899.
37 +
Garbarg-Chenon A, Segondy M, Conge AM, et al.  Virus isolation, polymerase chain reaction and in vitro antibody production for the diagnosis of pediatric human immunodeficiency virus infection. J Virol Methods . 1993;;42:117-125.
38 +
Guettari N, Silvy F, Tamalet C, et al.  Modified nested polymerase chain reaction for the detection of HIV-1 infection in children. AIDS . 1993;;7:1269-1271.
39 +
Krivine A, Firtion G, Cao L, Francoual C, Henrion R, Lebon P.  HIV replication during the first weeks of life. Lancet . 1992;;339:1187-1189.
40 +
Manak MM, Snider JV, Petersen D, Frederick W, Barnes S, Huang DP.  Use of PCR for detection of HIV-1 sequences in babies born to seropositive mothers. Ann N Y Acad Sci . 1993;;693:255-257.
41 +
Petru A, Dunphy MU, Azimi P, et al.  Reliability of polymerase chain reaction in the detection of human immunodeficiency virus infection in children. Pediatr Infect Dis J . 1992;;11:30-33.
42 +
Pollack H, Zhan MX, Ilmet MT, Tao P, Krasinski K, Borkowsky W.  A novel detection assay for the early diagnosis of HIV-1 infected infants. J Acquir Immune Defic Syndr . 1993;;6:582-586.
43 +
Puchhammer-Stockl E, Heinz FX, Prodinger WM, Kunz C.  Early diagnosis of perinatally acquired HIV infection by the polymerase chain reaction. Wien Klin Wochenschr . 1993;;105:429-432.
44 +
Simon F, Rahimy C, Krivine A, et al.  Antibody avidity measurement and immune complex dissociation for serological diagnosis of vertically acquired HIV-1 infection. J Acquir Immune Defic Syndr . 1993;;6:201-207.
45 +
Yourno J, Conroy J.  A novel polymerase chain reaction method for detection of human immunodeficiency virus in dried blood spots on filter paper. J Clin Microbiol . 1992;;30:2887-2892.
46 +
Chadwick EG, Yogev R, Kwok S, Sninsky JJ, Kellogg DE, Wolinsky SM.  Enzymatic amplification of the human immunodeficiency virus in peripheral blood mononuclear cells from pediatric patients. J Infect Dis. 1989;;160:954-959.
47 +
De Rossi A, Ades AE, Mammano F, 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.
48 +
De Rossi A, Amadori A, Chieco Bianchi L, et al.  Polymerase chain reaction and in-vitro antibody production for early diagnosis of paediatric HIV infection. Lancet . 1988;;2:278.
49 +
Edwards JR, Ulrich PP, Weintraub PS, et al.  Polymerase chain reaction compared with concurrent viral cultures for rapid identification of human immunodeficiency virus infection among high-risk infants and children. J Pediatr . 1989;;115:200-203.
50 +
Gupta P, Brady M, Raabe M, Urbach A.  Detection of human immunodeficiency virus by virus culture and polymerase chain reaction in children born to seropositive mothers. Acquir Immune Defic Syndr . 1991;;4:1004-1006.
51 +
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Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Ryder R, Hassig S.  The epidemiology of perinatal transmission of HIV. AIDS . 1988;;2( (suppl 1) ): S83-S89.
2 +
Ryder RW, Nsa W, Hassig SE, et al.  Perinatal transmission of the human immunodeficiency virus type 1 to infants of seropositive women in Zaire. N Engl J Med . 1989;;320:1637-1642.
3 +
Mok J, Giaquinto C, De Rossi A, Grosch-Wörner I, Ades A, Peckham C.  Infants born to HIV seropositive mothers: preliminary findings from a multi-centre European study. Lancet . 1987;;1:1164-1168.
4 +
European Collaborative Study.  Mother-to-child transmission of HIV infection. Lancet . 1988;;2:1039-1042.
5 +
Blanche S, Rouzioux C, Guihard-Moscato ML, et al, for the HIV Infection in Newborns French Collaborative Study Group.  A prospective study of infants born to women seropositive for human immunodeficiency virus type 1. N Engl J Med . 1989;; 320:1643-1648.
6 +
Connor EM, Sperling RS, Gelber R, et al.  Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment: Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med . 1994;; 331:1173-1180.
7 +
World Health Organization, Global Program on AIDS. The HIV/AIDS Pandemic: 1994 Overview . Geneva, Switzerland: World Health Organization; 1994;:13. Available from Pan American Health Organization, 525 23rd St NW, Washington, DC 20037.
8 +
Centers for Disease Control.  Classification system for human immunodeficiency virus (HIV) infection in children under 13 years of age. MMWR Morb Mortal Wkly Rep . 1987;;36:225-236.
9 +
Centers for Disease Control and Prevention.  1994 revised classification system for human immunodeficiency virus infection in children less than 13 years of age. MMWR Morb Mortal Wkly Rep . 1994;; 43:1-9.
10 +
El-Sadr W, Oleske JM, Agins BD, et al. Evaluation and Management of Early HIV Infection: Clinical Practice Guideline No. 7 . Rockville, Md: Agency for Health Care Policy and Research, Public Health Service, US Dept of Health and Human Services; January 1994;. Agency for Health Care Policy and Research publication 94-0572.
11 +
Rogers MF, Ou CY, Rayfield M, et al, for the New York City Collaborative Study of Maternal HIV Transmission and Montefiore Medical Center HIV Perinatal Transmission Study Groups.  Use of the polymerase chain reaction for early detection of the proviral sequences of human immunodeficiency virus in infants born to seropositive mothers. N Engl J Med . 1989;;320:1649-1654.
12 +
Escaich S, Wallon M, Baginski I, et al.  Comparison of HIV detection by virus isolation in lymphocyte cultures and molecular amplification of HIV DNA and RNA by PCR in offspring of seropositive mothers. J Acquir Immune Defic Syndr . 1991;;4: 130-135.
13 +
Fleiss J. Statistical Methods for Rates and Proportions . 2nd ed. New York, NY: John Wiley & Sons Inc; 1981;:13-17.
14 +
Moses L. Think and Explain With Statistics . Reading, Mass: Addison-Wesley Publishing Co; 1986;:250.
15 +
Owens DK, Holodniy M, Garber AM, et al.  The polymerase chain reaction for diagnosis of human immunodeficiency virus (HIV) infection in adults: a meta-analysis with recommendations for clinical practice and study design. Ann Intern Med . 1996;; 124:803-815.
16 +
Moses LE, Littenberg B, Shapiro D.  Combining independent studies of a diagnostic test into a summary ROC curve: data-analytic approaches and some additional considerations. Stat Med . 1993;;12: 1293-1316.
17 +
Kelsey J, Thompson W, Evans A. Methods in Observational Epidemiology . New York, NY: Oxford University Press; 1986;:366.
18 +
Robins J, Breslow N, Greenland S.  Estimators of the Mantel-Haenszel variance consistent in both sparse data and large strata-limiting models. Biometrics . 1986;;42:311-323.
19 +
Kent D, Haynor D, Larson E, Deyo R.  Diagnosis of lumbar spinal stenosis in adults: a meta-analysis of the accuracy of CT, MRI, and myelography. AJR Am J Roentgenol . 1992;;158:1135-1144.
20 +
Kent D, Larson E.  Disease, level of impact, and quality of research methods: three dimensions of clinical efficacy assessment applied to magnetic resonance imaging. Invest Radiol . 1992;;27:245-254.
21 +
Hoffman R, Kent D, Deyo R.  Meta-analysis of thermography for lumbar radiculopathy. Spine . 1991;;16:623-628.
22 +
Reid MC, Lachs MS, Feinstein AR.  Use of methodological standards in diagnostic test research: getting better but still not good. JAMA . 1995;;274: 645-651.
23 +
Arkin CF, Wachtel MS.  How many patients are necessary to assess test performance? JAMA . 1990;; 263:275-278.
24 +
Owens DK, Sox HC Jr.  Medical decision making: probabilistic medical reasoning.  In: Shortliffe E, Perreault L, Fagan L, Wiederhold G, eds. Medical Informatics: Computer Applications in Health Care . Reading, Mass: Addison-Wesley Publishing Co; 1990;:70-116.
25 +
Philbrick JT, Horwitz RI, Feinstein AR.  Methodologic problem in exercise testing for coronary artery disease: groups, analysis and bias. Am J Cardiol . 1980;;46:807-812.
26 +
Ransohoff DF, Feinstein AR.  Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med . 1978;;299:926-930.
27 +
Schwartz JS, Dans PE, Kinosian BP.  Human immunodeficiency virus test evaluation, performance, and use: proposals to make good tests better. JAMA . 1988;;259:2574-2579.
28 +
Borghi V, Lami G, Frigieri G, et al.  Polymerase chain reaction in the early diagnosis of HIV-1 infection in high risk subjects. Microbiologica . 1993;; 16:181-184.
29 +
Borkowsky W, Krasinski K, Pollack H, Hoover W, Kaul A, Ilmet-Moore T.  Early diagnosis of human immunodeficiency virus infection in children <6 months of age: comparison of polymerase chain reaction, culture, and plasma antigen capture techniques. J Infect Dis . 1992;;166:616-619.
30 +
Brandt C, Rakusan T, Sison A, et al.  Detection of human immunodeficiency virus type 1 infection in young pediatric patients by using polymerase chain reaction and biotinylated probes. J Clin Microbiol . 1992;;30:36-40.
31 +
Brandt CD, Rakusan TA, Sison AV, Saxena ES, Ellaurie M, Sever JL.  Human immunodeficiency virus infection in infants during the first 2 months of life: reliable detection and evidence of in utero transmission. Arch Pediatr Adolesc Med . 1994;;148: 250-254.
32 +
Cassol SA, Lapointe N, Salas T, et al.  Diagnosis of vertical HIV-1 transmission using the polymerase chain reaction and dried blood spot specimens. J Acquir Immune Defic Syndr . 1992;;5:113-119.
33 +
Comeau AM, Hsu HW, Schwerzler M, Mushinsky G, Grady GF.  Detection of HIV in specimens from newborn screening programs. N Engl J Med . 1992;;326:1703.
34 +
Comeau AM, Harris JA, McIntosh K, Weiblen BJ, Hoff R, Grady GF.  Polymerase chain reaction in detecting HIV infection among seropositive infants: relation to clinical status and age and to results of other assays. J Acquir Immune Defic Syndr . 1992;;5:271-278.
35 +
De Rossi A, Ometto L, Mammano F, Zanotto C, Giaquinto C, Chieco-Bianchi L.  Vertical transmission of HIV-1: lack of detectable virus in peripheral blood cells of infected children at birth. AIDS . 1992;; 6:1117-1120.
36 +
Denamur E, Levine M, Simon F, et al.  Conversion of HIV-1 viral markers during the first few months of life in HIV-infected children born to seropositive mothers. AIDS . 1993;;7:897-899.
37 +
Garbarg-Chenon A, Segondy M, Conge AM, et al.  Virus isolation, polymerase chain reaction and in vitro antibody production for the diagnosis of pediatric human immunodeficiency virus infection. J Virol Methods . 1993;;42:117-125.
38 +
Guettari N, Silvy F, Tamalet C, et al.  Modified nested polymerase chain reaction for the detection of HIV-1 infection in children. AIDS . 1993;;7:1269-1271.
39 +
Krivine A, Firtion G, Cao L, Francoual C, Henrion R, Lebon P.  HIV replication during the first weeks of life. Lancet . 1992;;339:1187-1189.
40 +
Manak MM, Snider JV, Petersen D, Frederick W, Barnes S, Huang DP.  Use of PCR for detection of HIV-1 sequences in babies born to seropositive mothers. Ann N Y Acad Sci . 1993;;693:255-257.
41 +
Petru A, Dunphy MU, Azimi P, et al.  Reliability of polymerase chain reaction in the detection of human immunodeficiency virus infection in children. Pediatr Infect Dis J . 1992;;11:30-33.
42 +
Pollack H, Zhan MX, Ilmet MT, Tao P, Krasinski K, Borkowsky W.  A novel detection assay for the early diagnosis of HIV-1 infected infants. J Acquir Immune Defic Syndr . 1993;;6:582-586.
43 +
Puchhammer-Stockl E, Heinz FX, Prodinger WM, Kunz C.  Early diagnosis of perinatally acquired HIV infection by the polymerase chain reaction. Wien Klin Wochenschr . 1993;;105:429-432.
44 +
Simon F, Rahimy C, Krivine A, et al.  Antibody avidity measurement and immune complex dissociation for serological diagnosis of vertically acquired HIV-1 infection. J Acquir Immune Defic Syndr . 1993;;6:201-207.
45 +
Yourno J, Conroy J.  A novel polymerase chain reaction method for detection of human immunodeficiency virus in dried blood spots on filter paper. J Clin Microbiol . 1992;;30:2887-2892.
46 +
Chadwick EG, Yogev R, Kwok S, Sninsky JJ, Kellogg DE, Wolinsky SM.  Enzymatic amplification of the human immunodeficiency virus in peripheral blood mononuclear cells from pediatric patients. J Infect Dis. 1989;;160:954-959.
47 +
De Rossi A, Ades AE, Mammano F, 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.
48 +
De Rossi A, Amadori A, Chieco Bianchi L, et al.  Polymerase chain reaction and in-vitro antibody production for early diagnosis of paediatric HIV infection. Lancet . 1988;;2:278.
49 +
Edwards JR, Ulrich PP, Weintraub PS, et al.  Polymerase chain reaction compared with concurrent viral cultures for rapid identification of human immunodeficiency virus infection among high-risk infants and children. J Pediatr . 1989;;115:200-203.
50 +
Gupta P, Brady M, Raabe M, Urbach A.  Detection of human immunodeficiency virus by virus culture and polymerase chain reaction in children born to seropositive mothers. Acquir Immune Defic Syndr . 1991;;4:1004-1006.
51 +
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To understand the clinical management of acute heart failure syndromes.
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Compression-Only CPR: Pushing the Science Forward
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AAM 2010;304:1493-1495.
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BMJ 2010;341:c5893-c1494.
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