Performance Data
Table 1 – Pathogen List
Herpes simplex
Herpes simplex
virus 1
virus 2
(HSV 1)
(HSV 2)
Mycoplasma
Neisseria
hominis
gonorrhoeae
(MH)
(NG)
Table 2 – Limit of Detection (per Test) Urine/Swab
HSV 1
HSV 2
188 / 188
602 / 602
viral particles
viral particles
MH
NG
1422 / 1422
111 / 111
CFU²
CFU²
¹ Elementary bodies
² Colony forming units
* 90 % positivity rate
Table 3 – Inclusivity
Chlamydia trachomatis
serotype A
Chlamydia trachomatis
serotype B
Chlamydia trachomatis
serotype Ba
Chlamydia trachomatis
serotype C
Chlamydia trachomatis
serotype D
Chlamydia trachomatis
serotype E
Table 4 – Exclusivity
Acinetobacter baumannii
Acinetobacter lwoffii
Atopobium vaginae
Bacteroides fragilis
Candida albicans
Candida glabrata
Candida krusei
(Issatchenkia orientalis)
Candida parapsilosis
Candida tropicalis
Chlamydophila pneumoniae
Citrobacter freundii
Cytomegalovirus (CMV/
HHV-5)
Enterobacter aerogenes
(Klebsiella aerogenes)
Enterobacter cloacae
Enterococcus faecalis
Enterococcus faecium
Chlamydia
trachomatis
(CT)
Treponema
pallidum
(TP)
CT
190 / 190
EB¹
TP
208 / 208
CFU²
Chlamydia trachomatis
serotype F
Chlamydia trachomatis
serotype G
Chlamydia trachomatis
serotype H
Chlamydia trachomatis
serotype I
Chlamydia trachomatis
serotype J
Chlamydia trachomatis
serotype K
Human papilloma virus 16
Human papilloma virus 18
Klebsiella oxytoca
Klebsiella pneumoniae
Lactobacillus acidophilus
Lactobacillus jensenii
Lactobacillus rhamnosus
Micrococcus luteus
Mobiluncus curtisii
Mobiluncus mulieris
Mycoplasma pneumoniae
Neisseria cinerea
Neisseria flavescens
Neisseria lactamica
Neisseria meningitidis
serogroup 29E
Neisseria meningitidis
serogroup A
46
Vivalytic STI Test
Haemophilus
Mycoplasma
ducreyi
genitalium
(HD)
(MG)
Ureaplasma
Trichomonas
urealyticum
vaginalis
(UU)
(TV)
HD
MG
2111 / 2111*
484 / 484
CFU²
CFU²
UU
TV
477 / 477
83 / 83
CFU²
CFU²
Chlamydia trachomatis
Swedish variant
Haemophilus ducreyi
Herpes simplex virus 1
Herpes simplex virus 2
Neisseria gonorrhoeae
Trichomonas vaginalis
Neisseria subflava
Peptostreptococcus
anaerobius
Prevotella intermedia
Proteus mirabilis
Proteus vulgaris
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
mecA-
Staphylococcus aureus
MRSA
Staphylococcus aureus
mecA+
Staphylococcus capitis
Staphylococcus epidermidis
Staphylococcus lugdunensis
Staphylococcus sciuri
Stenotrophomonas
maltophilia
Streptococcus agalactiae
(group B strep)
– Annex