What the panel detects
The panel covers bacteria, a protozoan, a yeast and two viruses that cause sexually transmitted or vaginal infections:
- Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and Mycoplasma genitalium
- Gardnerella vaginalis, Ureaplasma urealyticum, Ureaplasma parvum and Mycoplasma hominis
- Candida albicans and Treponema pallidum
- Herpes simplex virus types 1 and 2
How multiplex real-time PCR works
Real-time PCR copies a short, specific stretch of each organism's DNA and measures the copies as they form, using fluorescent probes. In a multiplex test, several probes with different fluorescent colours are read in the same tube, so one reaction reports several targets. This kit uses three reaction mixes (A, B and C), each reading four targets, plus an internal control.
Quality controls built into the test
An internal control in every reaction helps monitor reaction validity: if the internal control is absent when no target is detected, the test is repeated. A uracil-DNA glycosylase (UDG) system in the master mix removes DNA carried over from earlier runs, reducing false positives from laboratory contamination. Positive and negative controls are run with each batch.
When laboratories use it
The instructions for use list these situations: unprotected sexual contact with multiple partners, symptoms of a sexually transmitted infection, a partner with a known infection, and premarital health screening. Results are qualitative (detected or not detected).
Specimens and instruments
Validated specimens are vaginal swabs and urine. The kit runs on the Bio-Rad CFX96 and on QuantStudio 5 and 7 systems. It is labelled for research use only (RUO) in its instructions for use and is not for clinical diagnosis or patient management.