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Comparison of the Tellgenplex HPV DNA test with the PCR-reverse dot blot assay for human papillomavirus genotyping

Objective: To access the performance of the Tellgenplex human papillomavirus (HPV) DNA test compared to the polymerase chain reaction-reverse dot blot (PCR-RDB) assay for the HPV genotyping. Methods: Sixty cervical swab samples were genotyped by the Tellgenplex HPV DNA test and the PCR-RDB assay. The Tellgenplex HPV DNA test and the PCR-RDB assay can detect 26 and 23 HPV genotypes, respectively. Each sample showed discrepancy was genotyped using sequencing. Results: The percent agreement between the two tests ranged from 83.3% to 100.0% according to different genotype. This showed perfect agreement (>0.81) for high-risk HPV genotypes (35, 39, 45, 53, 56, 59, 66, 68, and 82), substantial agreement (>0.65) for high-risk HPV genotypes (16, 18, 33, 52, and 58) and low-risk HPV genotype 43 between the two assays by the kappa analysis. The positive rates of the two assays for frequent HPV genotypes (16, 35, 39, 45, 52, 53, 58, 59, 66, and 82) were not statistically different, but the PCR-RDB assay showed higher positive rates than the Tellgenplex HPV DNA test for HPV genotypes 81 (P<0.05). As for more than 10 positive results by the Tellgenplex HPV DNA test and/or the PCR-RDB assay, the PCR-RDB assay showed higher relative sensitivity and specificity than the Tellgenplex HPV DNA test for the three HPV genotypes (16, 52, and 81). All HPV genotypes that can be detected by only the Tellgenplex HPV DNA test (HPV genotypes 44 and 55) were confirmed by sequencing. Conclusions: In conclusion, our results demonstrated that the PCR-RDB assay which can detect more multiple HPV genotypes in each specimen shows higher relative sensitivity and specificity than the Tellgenplex HPV DNA test, which makes it a better option for routine clinical use.


Introduction
Cervical cancer is the 4 th most common female cancer worldwide.
More than 120 different human papillomavirus (HPV) types have been identified, of which have been divided into low-risk (LR) and high-risk (HR) type. LR HPVs are associated with genital warts, whereas HR HPVs are related to invasive cervical cancer [1].
Recently increasing evidences show that persistent infection with the same genotype increases the risk of developing cervical cancer [2]. Twelve HR HPVs (HPV 16,18,31,33,35,39,45,51,52,56, 58 and 59) are classified as carcinogenic HPV genotypes by the International Agency for Research on Cancer (IARC) and illuminate virtually all of cervical cancers [3]. It is widely known that HPV 16 and 18 are the main HR HPV types discovered in cervical cancer around the world; however, the prevalence of the other HR HPVs display geographical and regional differences [4][5][6].
HPV testing has already been recommended into cervical cancer screening guidelines in many countries [7], as well as an accessory examination to cytological screening such as cervical Papanicolau (Pap) smear. HPV testing alone can help to triage curative effect Objective: To access the performance of the Tellgenplex human papillomavirus (HPV) DNA test compared to the polymerase chain reaction-reverse dot blot (PCR-RDB) assay for the HPV genotyping. Methods: Sixty cervical swab samples were genotyped by the Tellgenplex HPV DNA test and the PCR-RDB assay. The Tellgenplex HPV DNA test and the PCR-RDB assay can detect 26 and 23 HPV genotypes, respectively. Each sample showed discrepancy was genotyped using sequencing. Results: The percent agreement between the two tests ranged from 83.3% to 100.0% according to different genotype. This showed perfect agreement (>0.81) for high-risk HPV genotypes (35, 39, 45, 53, 56, 59, 66, 68, and 82), substantial agreement (>0.65) for high-risk HPV genotypes (16,18,33,52, and 58) and low-risk HPV genotype 43 between the two assays by the kappa analysis. The positive rates of the two assays for frequent HPV genotypes (16,35,39,45,52,53,58,59,66, and 82) were not statistically different, but the PCR-RDB assay showed higher positive rates than the Tellgenplex HPV DNA test for HPV genotypes 81 (P<0.05). As for more than 10 positive results by the Tellgenplex HPV DNA test and/or the PCR-RDB assay, the PCR-RDB assay showed higher relative sensitivity and specificity than the Tellgenplex HPV DNA test for the three HPV genotypes (16, 52, and 81). All HPV genotypes that can be detected by only the Tellgenplex HPV DNA test (HPV genotypes 44 and 55) were confirmed by sequencing. Conclusions: In conclusion, our results demonstrated that the PCR-RDB assay which can detect more multiple HPV genotypes in each specimen shows higher relative sensitivity and specificity than the Tellgenplex HPV DNA test, which makes it a better option for routine clinical use.
in women with minor cytological abnormalities and cervical intraepithelial neoplasia [8].
Therefore, several molecular technologies are now available for detecting HPV genotyping such as hybridization with RNA probes, DNA chip, PCR, and sequencing [9][10][11] genotypes. Whatever their merits, the two assays provide limited genotyping information.
Nowadays a lot of commercial kits are available to identify HR and LR HPVs in cervical cytology specimens in China [14][15][16][17]. Among them, the Tellgenplex HPV DNA test and the polymerase chain reaction-reverse dot blot (PCR-RDB) assay were the representative HPV genotyping assays which were widely used [14,18,19]. The main drawbacks of the PCR-RDB assay are time consuming. Meanwhile, the Tellgenplex HPV DNA test, based on flow cytometry fluorescence hybridization method, only takes less than four hours during the detection. Moreover, the Tellgenplex HPV DNA test has the advantage of being automated, and it can detect more HPV genotypes. In our study, we first evaluated the performance of the Tellgenplex HPV DNA test compared to the PCR-RDB assay for the molecular genotyping of HPV.

DNA isolation
The cervical swabs were placed in a standard transport medium and were oscillated with a swirl. Then, 1 mL of this suspension was used as described using the SNIPER assay according to the recommendation of the manufacturer. Then, 2 μL of HPV DNA used for the SNIPER™ HR HPV assay as described in the text. The rest 1 mL of suspension was used to extract HPV DNA using the

Statistical analysis
Only the genotypes detected by both assays were considered for comparison. SPSS for Windows, version 19.0 (SPSS Inc., Chicago, IL) were used for statistical analyses. P<0.05 was considered statistically significant. The concordance between the results of two different tests was estimated by the agreement rate, kappa coefficient, proportion of positive agreement (P pos) , proportion of negative agreement (P neg ), and McNemar's P value (in cases of more than ten positive results) P<0.05 was considered statistically significant.

Relative sensitivity and specificity of individual genotypes
The sensitivities and specificities for the four HPV genotypes (

HPV genotypes detected by only the Tellgenplex HPV DNA test
The Tellgenplex HPV DNA test could detect additional HPV genotypes compared to the PCR-RDB assay, including HPV genotypes 44 and 61. All HPV genotypes that could be detected by only the Tellgenplex HPV DNA test were confirmed by sequencing; HPV genotypes 44 (n=1), and 61 (n=1).

Discussion
In some hospitals in China, HPV DNA was routinely tested by the Tellgenplex HPV DNA test or the PCR-RDB assay [14,18,19]. and can be completed in less than 4 h. We decided to identify a better assay which will be widely used to monitor disease progression and to examine the impact of widespread vaccination on prevalent HPV types in the future.
Overall, there was a good agreement between the Tellgenplex HPV DNA test and the PCR-RDB assay in this study. The agreement rates of the two assays were high, ranging from 83.3% to 100.0%.
Analyzing k values showed that the two assays had almost perfect concordance between HPV PCR-RDB testing and sequencing [14].
Previous study has reported that a total coincidence of 90.5% between the Tellgenplex HPV DNA test and the HC II was determined with a kappa value of 0.88 [19].
The detection rates of the two assays for frequent HPV genotypes (16,  Overall, for the HR HPV genotypes 16, 18, and 33, the Tellgenplex HPV DNA test and PCR-RDB assays showed substantial agreement; for the HR HPV genotype 31, they showed moderate agreement.
The potential benefits of using the HPV genotyping assay for primary cervical cancer screening are increasingly apparent [20].
There currently had no study to evaluate the Tellgenplex HPV DNA test and the PCR-RDB assay for detecting the HPV genotyping. We selected samples with HPV-positive results by the SNIPER HR-HPV assay and then directly compared the results of the Tellgenplex HPV DNA test and the PCR-RDB assay.
In conclusion, the Tellgenplex HPV DNA test shows substantial agreement with the PCR-RDB assay. However, the Tellgenplex HPV DNA test had lower detection rates than the PCR-RDB assay for HPV genotypes 42, 73, and 81. The study showed that the PCR-RDB assay which could detect more multiple HPV genotypes in one sample showed more sensitivity and specificity than the Tellgenplex HPV DNA test, which makes it a useful and valid alternative for HPV genotyping in clinical laboratories.