Lyme disease is an infectious disease caused by spirochaete bacteria from the genus Borrelia. The infection is transmitted by the bite of an infected tick and symptoms usually appear one week later. Symptoms include headache, fever, muscle soreness, unexplained fatigue and rash (erythema migrans). Following requests from participants, RCPAQAP Serology issued two Lyme Disease pilot surveys in 2015. After the successful pilot surveys, the Lyme Disease module was introduced in 2016.
In 2015 two Lyme Disease pilot surveys were distributed to 14 participants for testing as per routine laboratory protocols. Participants included six Australian and eight international laboratories. The first survey consisted of six specimens and the second survey consisted of two specimens. In 2016 the Lyme Disease module has been distributed to 14 participants (seven Australian and seven international), consisting of 2 surveys featuring 4 specimens. We have reviewed the pilot surveys and will review the first survey for 2016 in June when the survey closes.
For the detection of Lyme Disease, most participants used Lyme IgG and IgM or total antibody screening assays for the pilot surveys. Just over half the participants used a western blot in order to confirm their screening assay results. The majority of participants showed agreement of results for the screening assays in these studies. There was 100% agreement for the screening assay and western blot results for the negative specimens. For the positive specimens there was more variation in the results, particularly with the western blots, however this appeared to be kit related.
The introduction of a Lyme Disease QAP has facilitated the comparison of the different methods and algorithms used to detect Lyme Disease both in Australia and overseas, this and the QAP challenges will help improve laboratory testing.