TY - JOUR
T1 - Performance of the ResistancePlus MG diagnostic test for Mycoplasma genitalium using samples collected with Hologic Aptima Specimen Collection kits
AU - Murray, Gerald L.
AU - Danielewski, Jennifer
AU - Bradshaw, Catriona S.
AU - Williamson, Deborah A.
AU - Birnie, Joshua
AU - Su, Jenny P.
AU - De Petra, Vesna
AU - Tan, Lit Y.
AU - Wee, Rachel
AU - MacHalek, Dorothy A.
AU - Read, Tim R.H.
AU - Garland, Suzanne M.
PY - 2020
Y1 - 2020
N2 - Introduction. Mycoplasma genitalium is a sexually transmitted organism with high levels of resistance to the recommended first-line therapy, azithromycin. The ResistancePlus MG test concurrently detects M. genitalium, and the presence of macrolide-resistance mutations (MRM). European, UK and Australian guidelines recommend a diagnostic test that reports MRM to optimize treatment through resistance-guided therapy. Hence, for samples collected for use on other platforms, reflex testing using the ResistancePlus MG test would be beneficial. Aim. To validate the ResistancePlus MG assay using samples collected in Aptima buffer for testing on the Hologic Panther. Methodology. Positive (n=99) and negative (n=229) clinical samples collected in Aptima buffer were extracted on the MagNA Pure 96 (Roche Diagnostics), and tested with the ResistancePlus MG test on the LightCycler 480 II (Roche Diagnostics). Results were compared to matched samples collected using standard sample collection (urine or swab resuspended in PBS), with positive percent agreement (PPA), negative percent agreement (NPA) and Cohen's Kappa statistic. Results. The ResistancePlus MG test had high performance with a 200 μl input volume (PPA/NPA for M. genitalium detection, 92.9 % [95 % confidence interval (CI): 85.5-96.9]/100 % [95 % CI: 97.9-100], MRM detection, 96.9 % [95 % CI: 88.2-99.5]/85.7 % [95 % CI: 66.4-95.3]) and for 1 ml input volume (PPA/NPA for M. genitalium detection, 95.9%/96.6%, MRM detection, 98.4%/90.3%). Samples remained positive after storage at room temperature beyond the manufacturer-recommended storage of <60 days (mean storage time for 1 ml extraction: 129 days). Conclusion. Samples collected using Aptima collection kits are suitable for reflex testing using the ResistancePlus MG test, allowing detection of macrolide resistance.
AB - Introduction. Mycoplasma genitalium is a sexually transmitted organism with high levels of resistance to the recommended first-line therapy, azithromycin. The ResistancePlus MG test concurrently detects M. genitalium, and the presence of macrolide-resistance mutations (MRM). European, UK and Australian guidelines recommend a diagnostic test that reports MRM to optimize treatment through resistance-guided therapy. Hence, for samples collected for use on other platforms, reflex testing using the ResistancePlus MG test would be beneficial. Aim. To validate the ResistancePlus MG assay using samples collected in Aptima buffer for testing on the Hologic Panther. Methodology. Positive (n=99) and negative (n=229) clinical samples collected in Aptima buffer were extracted on the MagNA Pure 96 (Roche Diagnostics), and tested with the ResistancePlus MG test on the LightCycler 480 II (Roche Diagnostics). Results were compared to matched samples collected using standard sample collection (urine or swab resuspended in PBS), with positive percent agreement (PPA), negative percent agreement (NPA) and Cohen's Kappa statistic. Results. The ResistancePlus MG test had high performance with a 200 μl input volume (PPA/NPA for M. genitalium detection, 92.9 % [95 % confidence interval (CI): 85.5-96.9]/100 % [95 % CI: 97.9-100], MRM detection, 96.9 % [95 % CI: 88.2-99.5]/85.7 % [95 % CI: 66.4-95.3]) and for 1 ml input volume (PPA/NPA for M. genitalium detection, 95.9%/96.6%, MRM detection, 98.4%/90.3%). Samples remained positive after storage at room temperature beyond the manufacturer-recommended storage of <60 days (mean storage time for 1 ml extraction: 129 days). Conclusion. Samples collected using Aptima collection kits are suitable for reflex testing using the ResistancePlus MG test, allowing detection of macrolide resistance.
KW - Antibiotic resistance
KW - Aptima
KW - Diagnostic test
KW - Mycoplasma genitalium
KW - Quantitative PCR
UR - http://www.scopus.com/inward/record.url?scp=85080046183&partnerID=8YFLogxK
U2 - 10.1099/jmm.0.001140
DO - 10.1099/jmm.0.001140
M3 - Article
C2 - 31958047
AN - SCOPUS:85080046183
VL - 69
SP - 244
EP - 248
JO - Journal of Medical Microbiology
JF - Journal of Medical Microbiology
SN - 0022-2615
IS - 2
ER -