Head-to-head comparison of 7 high-sensitive human papillomavirus nucleic acid detection technologies with the SPF10 LiPA-25 system

Background:The SPF10 LiPA-25 system for human papillomavirus(HPV)detection with high analytical perfor-mance is widely used in HPV vaccine clinical trials.To develop and evaluate more valent HPV vaccines,other comparable methods with simpler operations are needed.Methods:The performance of the LiPA-25 against that of other 7 assays,including 4 systems based on reverse hybridization(Bohui-24,Yaneng-23,Tellgen-27,and Hybribio-16)and 3 real-time polymerase chain reaction(PCR)assays(Hybribio-23,Bioperfectus-21,and Sansure-26),was evaluated in selected 1726 cervical swab and 56 biopsy samples.A total of 15 HPV genotypes(HPV 6,11,16,18,31,33,35,39,45,51,52,56,58,59,and 66)were considered for comparison for each HPV type.Results:Among the swab samples,compared to LiPA-25,compatible genotypes were observed in 94.1%of samples for Hybribio-23,92.8%for Yaneng-23,92.6%for Bioperfectus-21,92.4%for Hybribio-16,91.3%for Sansure-26,89.7%for Bohui-24,and 88.0%for Tellgen-27.The highest overall agreement of the 15 HPV genotypes combined was noted for Hybribio-23(κ=0.879,McNemar’s test:P=0.136),followed closely by Hybribio-16(κ=0.877,P<0.001),Yaneng-23(κ=0.871,P<0.001),Bioperfectus-21(κ=0.848,P<0.001),Bohui-24(κ=0.847,P<0.001),Tellgen-27(κ=0.831,P<0.001),and Sansure-26(κ=0.826,P<0.001).Additionally,these systems were also highly consistent with LiPA-25 for biopsy specimens(all,κ>0.897).Conclusions:The levels of agreement for the detection of 15 HPV types between other 7 assays and LiPA-25 were all good,and Hybribio-23 was most comparable to LiPA-25.The testing operation of HPV genotyping should also be considered for vaccine and epidemiological studies.