Publication focus: Whatman FTA and HPV genotyping

Agreement for HPV genotyping detection between self-collected specimens on a FTA cartridge and clinician-collected specimens.Guan Y. et al. J Virol Methods. 2013 Apr;189(1):167-71.

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.

•Following washing of paper pieces taken from the FTA Elute cassette and elution of DNA in 50

ml of water in the prescribed method, a 10 ml aliquot was removed for PCR and genotyping

using the Roche HPV Linear Array (LA) test per the manufacturer’s instructions.

•Samples are kept dry at ambient temperature on the FTA Elute card, avoiding cost and

logistical challenges associated with transporting flammable & bio-hazardous liquid material.

•The small card size (7.3 cm × 3.8 cm) makes the FTA cartridge suitable for transportation by

regular mail.

•The disclosing purple indicator dye turns white where the sample is applied following clinician

or self-collection of cervicovaginal specimen, providing confidence in the procedure.

•For improved access, It will be important to pair the FTA device with DNA testing protocols

that can work in laboratory settings including those in non-urban low-resource settings.

•Of note, one non-PCR, signal amplification test, Hybrid Capture 2, performed poorly

compared to the PCR-based method using FTA devices. This suggests that further protocol

development may be needed to use non-PCR DNA testing methods.

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Regulatory Note: The study/data quoted in the paper above were not GEHC studies and GEHC makes no claims on the FTA or FTA Elute

instructions for use regarding any down-stream testing of the sample. The down-stream testing and any validation of these tests is

the responsibility of the end-user.

The Polymerase Chain Reaction (PCR) is covered by patents owned by Roche Molecular Systems and F Hoffmann-La Roche Ltd. All third

party trademarks are the property of their respective owners.  FTA is a trademark of GE Healthcare companies.