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The Abbott RealTime High Risk (HR) HPV assay is a qualitative in vitro polymerase chain reaction (PCR) assay that utilizes homogeneous target amplification and detection technology for the detection of high risk human papillomavirus (HPV) DNA in cervical cells collected in liquid cytology media.
The Abbott RealTime HR HPV assay is intended to detect 14 high risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and to partially genotype 16, 18 from other 12 high risk genotypes. Detection of the 14 high risk HPV genotypes and genotyping of HPV 16 and HPV 18 allow for improved risk assessment and patient management.* The Abbott RealTime High Risk HPV assay enables the laboratory to be ONE STEP AHEAD by detecting the 14 High Risk HPV genotypes and identifying HPV genotypes 16 and 18 WITH ONE SINGLE ASSAY. Comparison of two in situ hybridization methods in detection and typing of HPV, evaluation of the physical state of HPV DNA, and estimation of the number of positive cells.


The assay provides the necessary information for optimal patient stratification and allows for timely and cost effective HPV testing by consolidating the two diagnostic tools of screening and genotyping, thus saving time and money. In one case, the HPV was detected with CISH, but the result could not be confirmed with ISH TSA. In five cases in which a diffuse hybridization signal was visualized with CISH (Figure 3c), more cells with a dot hybridization signal were visualized (mixed hybridization signal, Figure 3d) with the ISH TSA system (Table 1). Furthermore, in five of the seven cases in which 1-5 positive cells per tissue sample were detected by CISH, more than five positive cells were detected by ISH TSA.


However, in three other cases, the number of infected cells was higher with CISH than with ISH TSA.
When the results on HPV status obtained by the two methods were compared using Mc Nemar’s test for correlated proportions, the differences for each of the parameters were statistically significant, in favor of the ISH TSA system (Table 1).



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