Agreement for HPV genotyping detection between self-collected specimens on a FTA cartridge and clinician-collected specimens

Abstract

The current method of transporting self-collected cervicovaginal specimen for HPV DNA testing relies on liquid based medium, which is challenging and expensive to transport. A novel, dry storage and transportation device, Whatman indicating FTA™ Elute Cartridge, avoids some of the pitfalls of liquid-based medium. This method has been shown to be comparable to liquid-based collection medium, but relative performance of self-collected (SC) and clinician-collected (CC) samples onto FTA cards has not been reported. The objective of this study is to compare the analytic performance of self- and clinician-collected samples onto FTA cartridges for the detection of carcinogenic HPV using Linear Array. There was a 91% agreement, 69% positive agreement, and kappa of 0.75 between the clinician-collected and self-collected specimens for detection of any carcinogenic HPV genotype. When the HPV results were categorized hierarchically according to cervical cancer risk, there was no difference in the distribution of the HPV results for the clinician- and self-collected specimens (p = 0.7). This study concludes that FTA elute cartridge is a promising method of specimen transport for cervical cancer screening programs considering using self-collected specimen and HPV testing. Larger studies with clinical endpoints are now needed to assess the clinical performance.

Immunoglobulin heavy and light chains and T‐cell receptor beta and gamma chains PCR assessment on cytological samples. A study comparing FTA cards and cryopreserved lymph node fine‐needle cytology

“…As far as the possible use of FTA cards for biobanking, the storage time did not influence the efficacy of FTA cards storage because, as reported above, the DNA extraction and PCR were performed at different times during and no differences were observed in PCR robustness in relation to the collection times. Whereas the oldest samples of our series were 2‐years old, previous studies have assessed an effective DNA storing and preservation by the FTA card longer than 17 years . With reference to the accuracy of FNC/FC and IGHK/TCRBG PCR, both the methods show high sensitivity, specificity, predictive values of positivity and negativity in clonality testing.…”

Clinical Evaluation of Human Papillomavirus Detection by careHPVTMTest on Physician-Samples and Self-Samples using The Indicating FTA Elute® Card

“…Recently, the FTA card has been actively explored in cervical cancer screening as an alternative for the current liquid-based sample carrier (Gustavsson et al, 2009;Lenselink et al, 2009;Gustavsson et al, 2011). It was promising that good agreement between liquid-based sample carrier and the solid FTA card were found for several PCR-based HPV testing methods, such as GP5+/6+ and SPF (10) PCR/ DEIA/LiPA (25) (Gonzalez et al, 2012;Guan et al, 2013). However, PCR-based HPV detective methods are mostly expensive and without clinical significance for detecting precancerous cervical lesions.…”

HPV Testing from Dried Urine Spots as a Tool for Cervical Cancer Screening in Low-Income Countries

“…Due to the introduction and increasing availability of novel and powerful high-throughput molecular technologies, the optimization of methods for biological samples collection and storage has become a critical issue. These results highlight the potential use of DUS samples as an alternative means of biobanking, avoiding the high costs and logistical problems associated with the storage and transportation, especially where a cold chain is absent [ 19 , 24 ]. Finally, DUS have a small size and can be easily mailed to a reference laboratory.…”

“…Few studies have evaluated the use of dried samples on filter paper for the detection of HPV infection, and these investigations examined exclusively cervical brush samples [ 17 – 19 ]. No data are presently available about the use of urine samples on this type of medium.…”