TABLE 3.
hrHPV positivity rate by EIA and LMNX in relation to clinical outcome, i.e., among women who had histologically confirmed high-grade disease (CIN2+ or CIN3+) in the follow-up and women who had normal cytology in the current and the previous screening round (<CIN1)a
| Study population and age group | CIN2+ |
CIN3+ |
<CIN1 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EIA positive |
LMNX positiveb |
EIA positive |
LMNX positiveb |
EIA positive |
LMNX positiveb |
|||||||
| % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | |
| Screening populationc | 100 | 13/13 | 100 | 13/13 | 100 | 8/8 | 100 | 8/8 | 9.7 | 72/746 | 9.5 | 69/746 |
| ≥30 yrs | 100 | 5/5 | 100 | 5/5 | 100 | 2/2 | 100 | 2/2 | 7.6 | 48/633 | 7.4 | 47/633 |
| <30 yrs | 100 | 8/8 | 100 | 8/8 | 100 | 6/6 | 100 | 6/6 | 21.2 | 24/113 | 19.5 | 22/113 |
| Enriched populationd | 93.3 | 83/89 | 95.5 | 85/89 | 97.9 | 46/47 | 97.9 | 46/47 | n/a | n/a | n/a | n/a |
| ≥30 yrs | 92.3 | 36/39 | 94.9 | 37/39 | 95.5 | 21/22 | 95.5 | 21/22 | n/a | n/a | n/a | n/a |
| <30 yrs | 94.0 | 47/50 | 96.0 | 48/50 | 100 | 25/25 | 100 | 25/25 | n/a | n/a | n/a | n/a |
| Overall population | 94.1 | 96/102 | 96.1 | 98/102 | 98.2 | 54/55 | 98.2 | 54/55 | 9.7 | 72/746 | 9.2 | 69/746 |
| ≥30 yrs | 93.2 | 41/44 | 95.5 | 42/44 | 95.8 | 23/24 | 95.8 | 23/24 | 7.6 | 48/633 | 7.4 | 47/633 |
| <30 yrs | 94.8 | 55/58 | 96.6 | 56/58 | 100 | 31/31 | 100 | 31/31 | 21.2 | 24/113 | 19.5 | 22/113 |
Positivity rates are stratified by population (screening, enriched, or overall) and subsequently by age group (women 30 years and older or women younger than 30 years old). <CIN1, women who had normal cytology during the current as well as the previous screening round 3 years earlier; CIN2+, women diagnosed with CIN2, CIN3, or invasive squamous carcinoma within 18 months of follow-up; CIN3+, women diagnosed with CIN3 or invasive squamous carcinoma within 18 months of follow-up; n/N, number of women with the indicated disease characteristics and test result/total number of women; n/a, not applicable.
A positive LMNX result represents detection of one or more of the following 14 HPV genotypes: HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, and HPV59 (12 HPVs classified by IARC as carcinogenic; class 1) and, additionally, HPV68 (class 2A) and HPV66 (class 2B).
Screening population: a study population of women consecutively attending a cervical cancer screening program.
Enriched population: a study population of women referred for abnormal cytology.