To improve the quality of laboratories in HPV detection and typing we run the program of external quality control - EHEQAS.
EHEQAS was founded in 2006 and by 2015 already 23 laboratories from 7 European countries are participating. Batches of 5-7 samples are sent from the coordinator to participants 1-2 times per year. Samples are either real patient samples (including cervical cell pellets) or prepared from international standards as standalone dilutions or mixtures with real patient samples. Samples that are not international standards are pre-tested by reference laboratories and only samples for which there is a high level of agreement between reference laboratories are used. To test for reproducibility, samples are used in duplicate in the same and in different rounds. Linearity is evaluated by different dilutions of the same sample in the same and in different rounds. Results are evaluated and consensus results are issued and announced to participants in a confidential way. Marks are awarded to participants based on defined rules that reflect the clinical value of the result (e.g. higher penalty for errors regarding types 16 and 18). Certificates of competence that reflect the performance of a laboratory during the past 4 years are issued.
Until now 205 samples have been tested in 20 rounds: 57 negative, 57 single infections, 91 co-infections. 31 different types (6, 11, 16, 18, 31, 33, 34, 35, 39, 40, 42, 43, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 66, 68, 70, 73, 81, 82, 83, 84) were detected during the period 2006-10 and the same 31 types were also fully represented during the period 2011-15. Laboratories using IVD tests made significant errors in HPV detection and typing, depending on the skills of laboratory personnel and on whether they correctly followed manufacturer’s instructions.
There is a gradual increase in the number of participants and in the quality of their performance. EHEQAS improves quality with the coordinating team providing feedback to participants on how to improve their methodology. EHEQAS assesses the quality of laboratories in: (a) detecting a shift in sensitivity and specificity in time. (b) HPV typing (high- or low-resolution). Successful participation in EHEQAS is extremely helpful to high-quality HPV labs that also verify or validate their methods: success in an EQA is a prerequisite for granting ISO15189 accreditation.