TY  - JOUR
T1  - Evaluation of human papillomavirus testing in primary screening for cervical abnormalities: Comparison of sensitivity, specificity, and frequency of referral
AU  - Kulasingam SL, Hughes JP, Kiviat NB, et al
Y1  - 2002/10/09
N1  - 10.1001/jama.288.14.1749
JO  - JAMA
SP  - 1749
EP  - 1757
VL  - 288
IS  - 14
N2  - Context 
                  Human papillomavirus (HPV) DNA testing of women having Papanicolaou
(Pap) smears showing atypical squamous cells of undetermined significance
(ASCUS) has clinical usefulness. Whether HPV DNA testing alone is useful in
primary screening remains to be determined.Objective 
                  To determine the accuracy of HPV DNA testing for detecting cervical
intraepithelial neoplasia (CIN) grade 3 or cancer (the criterion standard).Design, Setting, and Participants 
                  Between December 1997 and October 2000, 4075 women who attended Planned
Parenthood clinics in Washington State were screened simultaneously using
thin-layer Pap and HPV DNA testing by a polymerase chain reaction (PCR)–based
method and by a liquid-based RNA-DNA hybridization capture with signal amplification
assay (signal amplification). Women who were positive for high-risk HPV types,
or had Pap results of ASCUS or higher, were considered to have positive screening
test results and were referred for colposcopy and biopsy. Additionally, a
random sample of women with negative screening test results was referred for
colposcopy. Based on individual and combined thin-layer Pap, HPV PCR, and
HPV signal amplification test results from the screening and the colposcopy
visits, 7 colposcopy triage strategies were defined and evaluated.Main Outcome Measure 
                  Sensitivity and specificity for detecting cervical lesions graded CIN
3 or higher for each of the 7 triage strategies.Results 
                  The estimated prevalence of CIN 3 or higher was 3.2%. The sensitivity
(95% confidence interval) of thin-layer Pap (with a result of ≥ASCUS) for
identifying women with CIN 3 or higher was only 61.3% (48.5%-70.9%) compared
with 88.2% (78.9%-93.8%) for HPV testing by PCR and 90.8% (83.1%-95.8%) by
signal amplification. Differences in specificities were also observed: 82.4%
(81.8%-83.1%) for thin-layer Pap (with a result of ≥ASCUS), 78.8% (77.9%-79.7%)
for PCR, and 72.6% (69.4%-75.0%) for signal amplification. Compared with referral
for colposcopy of all women with ASCUS or higher, signal amplification testing
of women with ASCUS and referral of those with a positive result was about
as sensitive (61.3% vs 60.3%, respectively) and significantly more specific
(82.4% vs 88.9%, respectively). The strategy requiring repeat positive PCR
tests on 2 visits had a sensitivity of 84.2% (75.3%-91.0%) and a specificity
of 86.2% (85.1%-87.3%). All tests were more specific and less sensitive in
older (≥30 years) vs younger women.Conclusions 
                  Testing for HPV has higher sensitivity but lower specificity than thin-layer
Pap screening. In some settings, particularly where screening intervals are
long or haphazard, screening for HPV DNA may be a reasonable alternative to
cytology-based screening of reproductive-age women.
SN  - 0098-7484
M3  - doi: 10.1001/jama.288.14.1749
UR  - http://dx.doi.org/10.1001/jama.288.14.1749
ER  -