BD Affirm VPIII Anleitung

A ffirm™ VPIII
B
Microbial Identification Test
English: pages 1 – 8
français : pages 9 – 16
Deutsch: Seiten 17 – 24
Contact your local BD representative for instructions. / Свържете се с местния представител на BD за инструкзии. / Pokyny
vám poskytne místní zástupce společnosti BD. / Kontakt den lokale BD repræsentant for at få instruktioner. / Επικοινωνήστε με
τον τοπικό αντιπρόσωπο της BD για οδηγίες. / Kasutusjuhiste suhtes kontakteeruge oma kohaliku BD esindajaga. / Ota yhteys
lähimpään BD:n edustajaan ohjeiden saamiseksi. / Kontaktiraj lokalnog predstavnika BD za upute. / A használati utasítást kérje
a BD helyi képviseletétől. / Нұсқаулар үшін жергілікті BD өкілімен хабарласыңыз. / Lai saņemtu norādījumus, sazinieties
ar vietējo BD pārstāvi. / Naudojimo instrukcijų teiraukitės vietos BD įgaliotojo atstovo. / Neem contact op met uw plaatselijke
BD-vertegenwoordiger voor instructies. / Kontakt din lokale BD-representant for mer informasjon. / Aby uzyskać instrukcje
użytkowania, skontaktuj się z lokalnym przedstawicielstwem BD. / Contacte o representante local da BD para instruções. /
Pentru instrucţiuni, contactaţi reprezentantul local BD. / Для получения указаний обратитесь к местному представителю
компании BD. / Inštrukcie získate u miestneho zástupcu spoločnosti BD. / Obratite se svom lokalnom predstavniku kompanije
BD za uputstva. / Kontakta närmaste BD-representant för anvisningar. / Talimatlar için yerel BD temsilcinizle temasa geçin. / За
інструкціями зверніться до місцевого представника компанії BD.
INTENDED USE
The Affirm™ VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida
species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of
vaginitis/vaginosis.
SUMMARY AND EXPLANATION
Vaginitis, one of the most common problems in clinical medicine, accounts for more than 10 million office visits each year.
main categories of vaginitis are bacterial vaginosis (BV), yeast vaginitis (candidiasis) and T. vaginalis vaginitis (trichomoniasis). BV is
the most common vaginal infection, and accounts for 15 to 50% of vaginitis/vaginosis depending upon the patient population.
G. vaginalis is no longer thought to be the only etiologic agent of BV, it is still considered to be one of the major bacteria contributing to
the infection which involves an increase in anaerobic bacteria and reduction in the normal Lactobacillus flora. The complications of BV
can be especially significant in pregnant women, resulting in increased risk of adverse pregnancy outcome,
and birth. 7,8 In addition, recent data suggest BV-associated bacteria in the endometrium may be etiologic agents of endometritis and
pelvic inflammatory disease, independent of Neisseria gonorrhoeae and Chlamydia trachomatis infection.
the development of post-hysterectomy cuff cellulitis.
in varied clinical settings. 3
lifetime, with 40 to 50% experiencing a second episode. Approximately 5% of the adult female population suffers from recurrent, often
intractable yeast infection. 3
annually worldwide. 11 In the United States, an estimated 3 million women contract trichomoniasis each year.
for T. vaginalis are more likely to have pre-term rupture of membranes,
factor for the development of post-surgical gynecologic infections.
post-hysterectomy cuff cellulitis.
Laboratory methods for the identification of these organisms include microscopic evaluation, amine test, Gram stain, pH and culture.
PRINCIPLES Of ThE PROCEDURE
The Affirm VPIII Microbial Identification Test is based on the principles of nucleic acid hybridization. In nucleic acid hybridization tests,
complementary nucleic acid strands align to form specific, double-stranded complexes called hybrids.
The test uses two distinct single-stranded nucleic acid probes for each organism, a capture probe and a color development probe, that
are complementary to unique genetic sequences of the target organisms. The capture probes are immobilized on a bead embedded in a
Probe Analysis Card (PAC), which contains a separate bead for each target organism. The color development probes are contained in a
multi-well Reagent Cassette (RC).
During sample preparation, the sample is treated with the Lysis Solution (L) and heated. This process ruptures the walls of the
organism, releasing the nucleic acid analyte. A second solution, the Buffer Solution (B), is added. This solution stabilizes the nucleic
acid and establishes the stringency conditions necessary for specific hybridization. At this point, the sample is added to the first well of
the Reagent Cassette (RC) along with the PAC, and automated processing begins. The BD MicroProbe™ Processor moves the PAC
from one well of the Reagent Cassette (RC) to another. Hybridization occurs on the PAC beads in the first and second wells of the
Reagent Cassette (RC). Hybridization of the analyte to the capture probe on the bead occurs in well 1, and the hybridization of the color
development probes occurs in well 2. All unbound sample components and probes are washed away in well 3. Enzyme conjugate binds
to the captured analyte in well 4. Unbound conjugate is washed away in wells 5 and 6. In well 7, the indicator substrate is converted to
a blue-colored product if bound enzyme conjugate is present on the bead. The final step is reading the results of color development on
each of the target organism beads and controls.
REAGENTS
Materials Provided
Probe Analysis Cards (PAC) (24 or 120 tests): Individually packaged cards, wrapped in an absorbent paper towel moistened with
a solution containing sodium azide (0.1%, w/v) as a preservative. Each card contains the following five beads: Negative Control,
Trichomonas, Gardnerella, Candida, and Positive Control.
Italiano: pagine
Español: páginas
10
Three quarters of all adult women will experience at least one episode of vaginal candidiasis during their
Trichomoniasis, a non-reportable sexually transmitted disease, has been estimated to affect 180 million
16
25 – 32
33 – 40
Vaginal candidiasis is the second most common form of vaginal infection seen
7 as well as pre-term labor and birth.
14,15 In addition, T. vaginalis is a risk factor for the development of
670160JAA(02)
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2015-04
1 The three
2,3 While
4,5 including pre-term labor
9 BV is also a risk factor for
12 Pregnant women positive
13 T. vaginalis is a risk
6