BD ProbeTec Manual Del Usario página 2

ProbeTec

x
Q
English: pages 1 – 24
Français : pages 24 – 46
Patent Numbers: 5,270,184; 5,547,861; 5,648,211; 5,712,124; 5,744,311; 5,846,726; 5,851,767; 5,919,630; 6,010,857;
6,054,279; 6,077,669; 6,218,125; 7,371,531.
Pokyny vám poskytne místní zástupce spoleènosti BD. / Kontakt den lokale BD repræsentant for at få instruktioner. /
Kasutusjuhiste suhtes kontakteeruge oma kohaliku BD esindajaga. / ÅðéêïéíùíÞóôå ìå ôïí ôïðéêü áíôéðñüóùðï
ôçò BD ãéá ïäçãßåò. / A használati utasítást kérje a BD helyi képviseletétõl. / Naudojimo instrukcijø teiraukitës
vietos BD ágaliotojo atstovo. / Kontakt din lokale BD-representant for mer informasjon. / Aby uzyskaæ instrukcje
u¿ytkowania, skontaktuj siê z lokalnym przedstawicielstwem BD. / Contacte o seu representante local da BD para
obter instruções. / Inštrukcie získate u miestneho zástupcu spoloènosti BD. / Kontakta lokal Becton Dickinson-
representant för anvisningar. / Свържете се с местния представител на BD за инструкзии. / Contactaþi
reprezentantul dumneavoastrã local BD pentru instrucþiuni. / Talimatlar için yerel BD temsilcilerinize danıın. /
Obratite se svom lokalnom predstavniku kompanije BD za uputstva. / Для получения инструкций свяжетесь с
местным представителем компании BD.
INTENDED USE
The BD ProbeTec CT Q x
Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in
clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens
(in a clinical setting), and male and female urine specimens. The assay is indicated for use with asymptomatic and
symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
SUMMARY AND EXPLANATION
The World Health Organization estimates that 92 million new cases of infection due to Chlamydia trachomatis are
diagnosed each year. 1 In the United States, chlamydia is the most commonly reported infectious disease with over
1,000,000 cases in 2006, and case rates three fold higher among women than men.
have increased over the past decade in large part due to the expansion of screening programs for asymptomatic
individuals and the use of increasingly sensitive diagnostic tests. Seventy to 90% of chlamydia infections in women are
asymptomatic, with the result that long-term health problems can develop before a woman even knows she is at risk.
C. trachomatis can cause long-term sequelae such as pelvic inflammatory disease and infertility, in addition to the birth
of underweight babies. Fifty percent of C. trachomatis-infected men are also asymptomatic and, in the absence of
treatment, infection can result in acute urethritis or epididymitis and chronic proctitis. Transmission of C. trachomatis
occurs through sexual contact but can also take place in the birth canal leading to neonatal conjunctivitis and/or
chlamydial pneumonia.
Effective antibiotic treatment exists for chlamydial infections and the Advisory Committee on Human
Immunodeficiency Virus (HIV) and Sexually Transmitted Disease (STD) Prevention encourages active control programs
that target treatable STDs as a primary intervention in the HIV epidemic.
reduce transmission, the US Preventive Services Task Force has also published recommendations for screening young,
sexually active women and those who are older and considered at increased risk of infection.
The Chlamydiaceae are gram-negative, obligate intracellular bacteria that form characteristic intracellular inclusions
which can be observed in cell culture by fluorescence microscopy after antigen-specific staining is applied.
serovars of C. trachomatis are recognized comprising three groups, each of which is associated with a different disease
state: the trachoma serovars, A-C; the occulogenital serovars D-K; and the Lymphogranuloma venereum serovars,
L – L . Current methods for diagnosis of C. trachomatis infection include culture and immunological assays, as well as
1 3
the detection of nucleic acids by direct hybridization or amplification. Although historically culture has been the "gold
standard" for detection of C. trachomatis, the enhanced sensitivity of amplified methods has led to their increasing
adoption and in turn contributed to the rise in the number of reported cases of infection.
When used with the BD Viper System, the BD ProbeTec CT Q
oxide-based extraction of DNA from clinical specimens using BD FOX™ Extraction technology with the chemical
lysis of cells, followed by binding of DNA to para-magnetic particles, washing of the bound nucleic acid and elution
in an amplification-compatible buffer. When present, C. trachomatis DNA is then detected by Strand Displacement
Amplification (SDA) of a specific target sequence in the presence of a fluorescently-labeled detector probe.
PRINCIPLES OF THE PROCEDURE
The BD ProbeTec CT Q x
gonorrhoeae (CT/GC) Q
BD FOX Extraction. Specimens are collected and transported in their respective transport devices which preserve the
integrity of C. trachomatis DNA over the specified ranges of temperature and time.
Urine and swab specimens undergo a pre-warm step in the BD Viper Lysing Heater to dissolve mucus and homogenize
the specimen. After cooling, the specimens are loaded onto the BD Viper System which then performs all the steps
involved in extraction and amplification of target DNA, without further user intervention. The specimen is transferred
to an Extraction Tube that contains ferric oxide particles in a dissolvable film and dried Extraction Control. A high pH
is used to lyse the bacterial cells and liberate their DNA into solution. Acid is then added to lower the pH and induce
a positive charge on the ferric oxide, which in turn binds the negatively charged DNA. The particles and bound DNA
are then pulled to the sides of the Extraction Tube by magnets and the treated specimen is aspirated to waste. The
particles are washed and a high pH Elution Buffer is added to recover the purified DNA. Finally, a Neutralization
Buffer is used to bring the pH of the extracted solution to the optimum for amplification of the target.
The BD ProbeTec CT Q x
DNA using amplification primers and a fluorescently-labeled detector probe.
™
Chlamydia trachomatis (CT)
Amplified DNA Assay
Deutsch: Seiten
Español: páginas 72 – 95
Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses
4
Amplified DNA Assay is designed for use with the BD ProbeTec Chlamydia trachomatis/Neisseria
x specimen collection and transport devices, applicable reagents, the BD Viper System and
Amplified DNA Assay is based on the simultaneous amplification and detection of target
47 – 71
5 In order to prevent complications and
x Amplified DNA Assay involves automated ferric
8,9
U
2 Case rates for chlamydia infection
3,6
The reagents for SDA are dried in
8081408
2009/01
0344
3
7
Fifteen
8,9