Quality control and external quality assessment for the independent clinic-based evaluation of point-of-care testing to detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in eight countries

Table 2 Composition of the swabs prepared by NRL for quality control (QC) and external quality assessment (EQA) testing^b

Composition	CT only	NG only	CT/NG Duo	TV only	Negative
Concentration	4 × 10⁴ DNA copies/mL	4 × 10⁴ DNA copies/mL	4 × 10⁵ DNA copies/mL of both CT and NG	1/500 dilution of liquid culture^a	PBS only, no organisms
Internal control (baseline)	Uninfected Huh-7 cells, 2 × 10⁵ cells/mL

The QC samples consisted of the CT/NG Duo and the TV only swab samples. The EQA samples consisted of any combination of the five manufactured samples
CT Chlamydia trachomatis, NG Neisseria gonorrhoeae, TV Trichomonas vaginalis
^a designed to provide a target cycle threshold of between 30 and 35
^b Previous studies showed that (i) the concentrations provided in these samples showed an insignificant variation in Ct value when stored at -20 °C or 23-25 °C and (ii) the material was stable for at least 2 years when stored at 2-8 °C [15, 16]. According to the manufacturer, the TV material provided for this study was produced following the same process as described for CT/NG, however no validation data was provided

ISSN: 1471-2334