BD ProbeTec Manual Del Usario página 20

CT Q x Assay Analytical Sensitivity:
The Limits of Detection (LODs) for the CT Q
extracted on the BD Viper System were determined to be < 15 CT elementary bodies (EB) per mL for neat and Q
urine and < 30 CT EB per mL for expressed vaginal and endocervical swab specimens. A correlation of EB to Inclusion-
forming units (IFU) suggests that the CT Q
to < 1 IFU per mL. 20 The CT Q
representing 15 CT serovars (A, B, Ba, C, D, E (2), F, G, H, I, J, K, LGV1, LGV2, and LGV3) with ≥ 95% proportion positive
at a concentration of 15 EB per mL in CT/GC Q
*Testing with CT serovar E included the nvCT strain, a new variant with a deletion in the cryptic plasmid.
CT Q x Assay Analytical Specificity:
DNA from 141 organisms listed in Table 12 was extracted on the BD Viper System and tested with the BD ProbeTec CT
Amplified DNA Assay. All potential cross-reactive species were tested at ≥ 1x10
Q x
x
CT Q Assay did not cross-react with any of the organisms tested.
Table 12: Potential Cross-reacting Microorganisms
Acinetobacter calcoaceticus Epstein Barr Virus ***
Acinetobacter lwoffi
Actinomyces israelii
Adenovirus***
Aeromonas hydrophilia
Alcaligenes faecalis*
Bacillus subtilis*
Bacteroides fragilis
Candida albicans*
Candida glabrata*
Candida tropicalis*
Chlamydia pneumoniae**** Lactobacillus brevis
Chlamydia psittaci*
Citrobacter freundii
Clostridium perfringens
Corynebacterium renale
Cryptococcus neoformans*
Cytomegalovirus**
Edwardsiella tarda
Enterobacter cloacae
Enterococcus faecalis
Enterococcus faecium
(n) number of strains tested in the BD ProbeTec CT Q
7
* Tested at > 1x10 cells or EB per mL; **Tested at > 1x10
equivalents per mL;**** tested at ≥ 1x10
CT Q x Interfering Substances
The performance of the BD ProbeTec CT Q
presence of potential interfering substances which may be encountered in swab and/or urine specimens. Potential
interfering substances were spiked into Q
and the absence of CT elementary bodies (30 CT EB/mL in urine matrix and 90 CT EB/mL in swab matrix). Results are
summarized in Table 13.
x
Assay with C. trachomatis serovar H in urine and swab specimens when
x assay LODs with serovar H in urine and swab specimens correspond
x Assay on the BD Viper System in extracted mode was able to detect 16 isolates
x Swab Diluent.
Escherichia coli
Flavobacterium
meningosepticum
Gardnerella vaginalis
Gemella haemolysans
Haemophilus influenzae
Herpes Simplex Virus **
Human papillomavirus
(16 and 18)***
Kingella kingae
Klebsiella pneumoniae
Lactobacillus acidophilus*
Lactobacillus jensenii*
Listeria monocytogenes
Mobiluncus mulieris
Moraxella lacunata*
Moraxella osloensis
Morganella morganii
Mycobacterium gordonae
Mycobacterium smegmatis
Peptostreptococcus
anaerobius
Peptostreptococcus
asaccharolyticus
5
TCID /mL
50
x Assay on the BD Viper System in extracted mode was evaluated in the
x
UPT urine and vaginal swab specimen matrices in both the presence
Peptostreptococcus
productus
Plesiomonas shigelloides
Propionibacterium acnes
Providencia stuartii
Pseudomonas aeruginosa
Salmonella minnesota
Salmonella typhimurium
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus agalactiae
Streptococcus mitis
Streptococcus mutans
Streptococcus pneumoniae* Neisseria weaverii (3)
Streptococcus pyogenes
Streptomyces griseus**
Trichomonas vaginalis**
Veillonella parvula
Vibrio parahaemolyticus
Yersinia enterocolitica
Branhamella catarrhalis (5)
Neisseria cinerea (2)
Neisseria elongata subsp.
glycolytica
x Assay
cells or viral particles per mL; ***Tested at ≥ 1x10
6
19
21
8 cells/mL except where noted. The
Neisseria elongata subsp.
nitroreduscens (2)
Neisseria elongata
Neisseria flava (4)
Neisseria flavescens (4)
Neisseria gonorrhoeae
Neisseria lactamica (7)
Neisseria meningitidis (12)
Neisseria mucosa (5)
Neisseria perflava (8)
Neisseria polysaccharea (2)
Neisseria sicca (5)
Neisseria subflava (15)
x UPT
6
genomic