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WARNING
Hazard components in cartridge F 09 G300 078
• Lysis Buffer
Guanidinium chloride; guanidine hydrochloride
• Elution Buffer
Hydrogen peroxide-Urea (1:1)
• Extraction Wash Buffer
reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and
2-methyl-2H-isothiazol-3-one (3:1)
Hazard statements
H302 Harmful if swallowed.
H315 Causes skin irritation.
H317 May cause an allergic skin reaction.
H319 Causes serious eye irritation.
H412 Harmful to aquatic life with long lasting effects.
Precautionary statements
P261
Avoid breathing dust/fume/gas/mist/vapours/spray.
P280
Wear protective gloves/protective clothing/eye
protection/face protection.
P302+P352
IF ON SKIN: Wash with plenty of soap and water.
P333+P313
If skin irritation or rash occurs: Get medical advice/attention.
P362+P364
Take off contaminated clothing and wash it before reuse.
P501
Dispose of contents/container to local/regional/ national/
international regulations.
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
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
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
– Annex
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