Background / Objectives *
The aim of this study is to evaluate the performance of the Cobas 4800 HPV test and Aptima HPV Assay by comparing their results to those obtained in the Hybrid Capture 2.
We have studied 736 cervical samples, which were obtained from women attending gynecology practitioners, in the cervical pathology unit from our hospital, in a routine cervical cancer screening program.
All specimens were collected with PreservCyt transport medium.
Each sample was analyzed with Cobas 4800 HPV (Roche Molecular System, Inc ), E6/E7 mRNA-based Aptima® HPV(AHPV; (Hologic, Inc) and Hybrid Capture 2 HPV DNA test (HC2; Qiagen).
In each patient we made Pap smears, and byopsie an p16 when the patient required it.
Statistics analyses were done with SPSS 18 for windows.
The average age was 38.02 (19-90).
The prevalence of HPV in each test is shown in Table 1
| HPV | HC2 | DNA Cobas 4800 | mRNA AHPV |
| Positive | 44,4% (327) | 50,1% (369) p=0.032 | 41,0% (302) |
| Negative | 51,9% (382) | 49,9% (367) | 59,0% (434) |
Kappa value DNA Cobas 4800 = 0.834
Kappa value mRNA AHPV =0.805
Our Pap smear distribution, and the frequency of HPV in each category is shown in Table 2
| Cytology | % HC2 Positive | %Cobas 4800 Positive | % APTIMA Positive |
|---|---|---|---|
| Negative (n=450) | 26,8 | 28,4 | 20,4 |
| ASCUS (n=56) | 66,0 | 75,0 | 62,5 |
| LSIL (n=108) | 81,4 | 85,1 | 74,1 |
| HSIL (n=112) | 88,3 | 91,9 | 84,0 |
203 patients had a CIN2+ biopsy result and for HPV, the results obtained were: HC2 (90,3%), Cobas 4800 (93,8%) and AHPV 88,5%. There were no statistically significant differences in frequency of HPV between techniques.
p16 made in 483 biopsies and the results were associated more frequently with the samples mRNA positives: 78,01% versus 75,1% for both DNA techniques.
We calculated the sensitivity and specificity for both techniques:
mRNA E6/E7 AHPV sensitivity = 0.83 [95% CI: 0.79-0.87] specificity = 0.99 [95% CI: 0.94-0.99]
Cobas 4800 DNA sensitivity = 0.94 [95% CI: 0.91-0.96] specificity = 0.90 [0.95% CI: 86-0.92]
Hybrid Capture 2, Cobas 4800 HPV and Aptima HPV Assay showed a high degree of agreement in the results obtained.
In our data, similar sensitivities of Aptima HPV Assay and Hybrid Capture 2 were observed and in Cobas 4800 HPV the sensitivity was higher (p=0.032).
The better specificity of Aptima HPV, support the use of Aptima mRNA as a safe and effective adjunctive cervical cancer screening method.
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