BD ProbeTec Manual Del Usario página 11

5. Tightly recap the tube using the black pierceable cap.
6. Repeat for each desired area.
7. After all swabs have been collected, expressed in diluent, process according to the Pre-warming Procedure and
then follow the Test Procedure.
*Recommended areas to test include: Instrument deck: Pipette Tip Station Covers (2); Tube Processing Station: Tube
Alignment Block and Fixed Metal Base; Deck Waste Area, Priming and Warming Heaters/Stage; Extraction Block; Plate
Sealing Tool; Tip Exchange Stations (2); Instrument Exterior: Upper Door Handle; Lower Door Handle; Waste Liquid
Quick Release Valve; LCD Monitor (Touchscreen); Keyboard/Scanner; Staging Area; Locking Plate and Fixed Metal Base;
Accessories: Tube Lockdown cover, BD Viper Lysing Rack/Table Base; BD Viper Lysing Heater; Metal Microwell Plates;
Timer; Laboratory Bench Surfaces.
If an area gives a positive result or if contamination is suspected, clean the area with fresh 1% (v/v) sodium
hypochlorite, DNA AWAY, or 3% (w/v) hydrogen peroxide. (Do not use hydrogen peroxide from a bottle that has
remained open for longer than 8 days). Make sure the entire area is wetted with the solution and allowed to remain
on the surface for at least 2 min or until dry. If necessary, remove excess cleaning solution with a clean towel. Wipe the
area with a clean towel saturated with water and allow the surface to dry. Retest the area. Repeat cleaning process
until negative results are obtained. If the contamination does not resolve, contact BD Technical Services for additional
information.
LIMITATIONS OF THE PROCEDURE
1. This method has been tested only with endocervical, vaginal, male urethral swab specimens, and male and female
urine specimens. Performance with other specimen types has not been assessed.
2. Optimal performance of the test requires adequate specimen collection and handling. Refer to the "Specimen
Collection and Transport" sections of this insert.
3. Endocervical specimen adequacy can only be assessed by microscopic visualization of columnar epithelial cells in
the specimen.
4. Collection and testing of urine specimens with the BD ProbeTec CT Q
replace cervical exam and endocervical sampling for diagnosis of urogenital infection. Cervicitis, urethritis, urinary
tract infections and vaginal infections may result from other causes or concurrent infections may occur.
5. The BD ProbeTec CT Q
first catch random urine specimens (the first 20 – 60 mL of the urine stream).
6. The effects of other potential variables such as vaginal discharge, use of tampons, douching, and specimen
collection variables have not been determined.
7. A negative test result does not exclude the possibility of infection because test results may be affected by
improper specimen collection, technical error, specimen mix-up, concurrent antibiotic therapy, or the number of
organisms in the specimen which may be below the sensitivity of the test.
8. As with many diagnostic tests, results from the BD ProbeTec CT Q
conjunction with other laboratory and clinical data available to the physician.
9. The BD ProbeTec CT Q
10. The BD ProbeTec CT Q
for other medico-legal indications. Additional testing is recommended in any circumstance when false positive or
false negative results could lead to adverse medical, social, or psychological consequences.
11. The BD ProbeTec CT Q
acids from C. trachomatis may persist following antimicrobial therapy.
12. The BD ProbeTec CT Q
the magnitude of the positive assay signal (MaxRFU) and the number of cells in an infected sample.
13. The predictive value of an assay depends on the prevalence of the disease in any particular population. See Table 5
for hypothetical predictive values when testing varied populations.
14. Because the Positive Control for the BD ProbeTec CT/GC Q
C. trachomatis and N. gonorrhoeae, correct positioning of the microwell strips is important for final results
reporting.
15. Use of the BD ProbeTec CT Q
procedure and the BD Viper System.
16. The reproducibility of the BD ProbeTec CT Q
and seeded CT/GC Q
C. trachomatis alone or C. trachomatis plus N. gonorrhoeae.
17. Performance has not been established for urine specimens in Q
within the black lines on the fill window (approximately 2.0 mL to 3.0 mL) are used.
18. The performance of the BD ProbeTec CT Q
with swab specimens was evaluated for interference by blood, gynecological lubricants, and spermicides. The
performance with urine specimens was evaluated for interference by blood and commonly used over-the-counter
pain relievers. No interference was observed with any of the substances at the concentrations tested.
19. The patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not
otherwise indicated.
20. The patient-collected vaginal swab specimen application is limited to healthcare facilities where support/
counseling is available to explain procedures and precautions.
21. The BD ProbeTec CT Q
patients at home.
22. The performance of vaginal swab specimens has not been evaluated in patients less than 17 years of age.
23. The performance of vaginal swab specimens has not been evaluated in pregnant women.
x Amplified DNA Assay for male and female urine specimen testing should be performed on
x Amplified DNA Assay does not detect plasmid-free variants of C. trachomatis.
x Amplified DNA Assay should not be used for the evaluation of suspected sexual abuse or
x Amplified DNA Assay cannot be used to assess therapeutic success or failure since nucleic
x Amplified DNA Assay provides qualitative results. No correlation can be drawn between
x
Amplified DNA Assay is limited to personnel who have been trained in the assay
x Swab Diluent to simulate urine specimens. These specimens were inoculated with either
x
x Amplified DNA Assay has not been validated for vaginal swab specimens collected by
x Amplified DNA Assay should be interpreted in
x Amplified DNA Assays is used in testing for both
x Amplified DNA Assay was established using seeded simulated swabs
x UPT when fill volumes other than those falling
Amplified DNA Assay on the BD Viper System in extracted mode
10
x Amplified DNA Assay is not intended to