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 BD Probetec™ ET CT/GC Reagent Pack, 384 Tests |
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| Cat. # | Desc. | Qty. | Unit |
| 440705 | BD Probetec™ ET CT/GC Reagent Pack, 384 Tests | 1 | EA |
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The BD ProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper™ instrument.
| Catalog # | Description | Quantity | Unit |
| 440705 | BD Probetec™ ET CT/GC Reagent Pack, 384 Tests | 1 | EA |
The BD ProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper™ instrument. The BD ProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper™ instrument. Chlamydia trachomatis and Neisseria gonorrhoeae infections are the most common sexually transmitted bacterial diseases in the United States. Approximately 4 million new chlamydia cases are estimated to occur each year in the United States with worldwide estimates of approximately 50 million new cases annually.1-3 The incidence of chlamydial infections in women in the US in 1996 was 186.6 per 100,000. The total number of chlamydial infections and gonorrhea cases reported in the US in 1996 were 490,080 and 325,883, respectively.2 Chlamydiae are gram-negative, obligate intracellular bacteria. They form characteristic intracellular inclusions which can be observed in cell culture by light microscopy after special staining is applied.4 Chlamydia trachomatis causes cervicitis, urethritis, salpingitis, proctitis and endometritis in women and urethritis, epididymitis and proctitis in men. Acute infections are reported more frequently in men because women often have no symptoms of infection. It has been estimated that 70 – 80% of women and up to 50% of men who are infected experience no symptoms. Many chlamydial infections in women remain untreated which may result in low-grade inflammation in the Fallopian tubes, a leading contributor to infertility. This organism can also be transmitted in the birth canal, potentially resulting in infant conjunctivitis and/or chlamydial pneumonia in newborns.4,5 Neisseria gonorrhoeae are gram-negative, oxidase positive diplococci which can be observed in Gram-stained smears of urethral discharges, usually within neutrophils. Culture of N. gonorrhoeae can be difficult because the organism does not survive long outside its host and is highly susceptible to adverse environmental conditions such as drying and extreme temperatures.6 Neisseria gonorrhoeae causes acute urethritis in males, which if untreated can develop into epididymitis, prostatitis, and urethral stricture. In females, the primary site of infection is the endocervix. An important complication in females is development of pelvic inflammatory disease which contributes to infertility.7 Asymptomatic infections occur often in females but infrequently in males. The current methods for detection of C. trachomatis and/or N. gonorrhoeae include culture, immunoassays, nonamplified probes, and amplified probes.4,6,7 The development of amplified methods has demonstrated two advantages over non-amplified methods: increased sensitivity, and applicability to a variety of sample types. Historically, culture has been the "gold standard" for detection of C. trachomatis. However, the culture yield varies widely among laboratories, and culture in routine practice is less sensitive than amplified methods. Combining results from multiple methods of CT detection improves accuracy for evaluating new tests in that infected and uninfected patients can be more reliably identified. For identification of GC, optimized culture methods continue to be the standard for diagnosing patients with gonococcal infections. The BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when used with the BD ProbeTec ET System, utilize homogeneous Strand Displacement Amplification (SDA) technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of C. trachomatis and N. gonorrhoeae DNA in clinical specimens.8-10 Chlamydia trachomatis and Neisseria gonorrhoeae infections are the most common sexually transmitted bacterial diseases in the United States. Approximately 4 million new chlamydia cases are estimated to occur each year in the United States with worldwide estimates of approximately 50 million new cases annually.1-3 The incidence of chlamydial infections in women in the US in 1996 was 186.6 per 100,000. The total number of chlamydial infections and gonorrhea cases reported in the US in 1996 were 490,080 and 325,883, respectively.2 Chlamydiae are gram-negative, obligate intracellular bacteria. They form characteristic intracellular inclusions which can be observed in cell culture by light microscopy after special staining is applied.4 Chlamydia trachomatis causes cervicitis, urethritis, salpingitis, proctitis and endometritis in women and urethritis, epididymitis and proctitis in men. Acute infections are reported more frequently in men because women often have no symptoms of infection. It has been estimated that 70 – 80% of women and up to 50% of men who are infected experience no symptoms. Many chlamydial infections in women remain untreated which may result in low-grade inflammation in the Fallopian tubes, a leading contributor to infertility. This organism can also be transmitted in the birth canal, potentially resulting in infant conjunctivitis and/or chlamydial pneumonia in newborns.4,5 Neisseria gonorrhoeae are gram-negative, oxidase positive diplococci which can be observed in Gram-stained smears of urethral discharges, usually within neutrophils. Culture of N. gonorrhoeae can be difficult because the organism does not survive long outside its host and is highly susceptible to adverse environmental conditions such as drying and extreme temperatures.6 Neisseria gonorrhoeae causes acute urethritis in males, which if untreated can develop into epididymitis, prostatitis, and urethral stricture. In females, the primary site of infection is the endocervix. An important complication in females is development of pelvic inflammatory disease which contributes to infertility.7 Asymptomatic infections occur often in females but infrequently in males. The current methods for detection of C. trachomatis and/or N. gonorrhoeae include culture, immunoassays, nonamplified probes, and amplified probes.4,6,7 The development of amplified methods has demonstrated two advantages over non-amplified methods: increased sensitivity, and applicability to a variety of sample types. Historically, culture has been the "gold standard" for detection of C. trachomatis. However, the culture yield varies widely among laboratories, and culture in routine practice is less sensitive than amplified methods. Combining results from multiple methods of CT detection improves accuracy for evaluating new tests in that infected and uninfected patients can be more reliably identified. For identification of GC, optimized culture methods continue to be the standard for diagnosing patients with gonococcal infections. The BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when used with the BD ProbeTec ET System, utilize homogeneous Strand Displacement Amplification (SDA) technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of C. trachomatis and N. gonorrhoeae DNA in clinical specimens.8-10 The BD ProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae positive and negative control set is provided separately. One positive and one negative control must be included in each assay run and for each new reagent kit lot number. Controls may be randomly positioned. The CT/GC positive control will monitor for substantial reagent failure only. The CT/GC negative control monitors for reagent and/or environmental contamination. The positive control has both cloned CT and GC target regions that are not necessarily representative of organism target DNA detected by the assay nor do they represent specimen matrices (urine and epithelial cell suspensions) indicated for use with the BD ProbeTec ET System. These controls may be used for internal quality control or users may develop their own internal quality control material, as described by CLSI C24-A3.15 Additional controls may be tested according to guidelines or requirements of local, state, and/or federal regulations or accrediting organizations. Refer to CLSI C24-A3 for additional guidance on appropriate internal quality control testing practices. The positive control contains 750 copies per reaction of pCT16 linearized plasmid and 250 copies per reaction of pGC10 linearized plasmid. Both organisms have multiple copies of the target. The BD ProbeTec ET amplification reaction volume is 100 μL of rehydrated control. Because the CT/GC positive control is used for both CT and GC testing, correct positioning of the microwell strips is important for proper result reporting. Refer to Section H of the "Test Procedure" for correct microwell strip positioning. The CT/GC positive and CT/GC negative control must test as positive and negative, respectively, in order to report patient results. If controls do not perform as expected, the assay run is considered invalid and patient results will not be reported by the instrument. If the QC does not meet the expected results, repeat the entire run using a new set of controls, new microwells, and the processed specimens. If the repeat QC does not provide the expected results, contact Technical Services. (See "Interpretation of Results.") Refer to Section F of the "Test Procedure" for directions on preparing the controls. Once the controls have been prepared, continue with testing as described in Section G of the "Test Procedure." A separate Amplification Control (AC) is an option for inhibition testing and is available in the CT/GC/AC Reagent Pack. When the CT/GC/AC Reagent Pack is used, the AC must be included for each patient sample and control. The Amplification Control microwells contain ≥ 1000 copies per reaction of pGC10 linearized plasmid that should be amplified in the sample matrix. The amplification control is designed to identify samples that may contain amplification inhibitors that could prevent detection of CT or GC DNA if present. (See "Interpretation of Results.") Each BD ProbeTec ET CT/GC Reagent Pack contains: Chlamydia trachomatis (CT) Priming Microwells, 4 x 96: For in vitro Diagnostic Use 1. This reagent pack is for testing endocervical and male urethral swabs and male and female urine specimens with the BD ProbeTec ET System. 2. For collection of endocervical swab specimens, only the BD ProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit and the BD ProbeTec ET CT/GC Amplified DNA Assay Collection Kit for Endocervical Specimens have been validated. 3. For collection of male urethral swab specimens, only the BD ProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit and the BD ProbeTec ET CT/GC Amplified Assay Collection Kit for Male Urethral Specimens have been validated. 4. For urine specimens, only the BD ProbeTec ET Urine Processing Pouch (UPP), the BD ProbeTec Urine Preservative Transport (UPT), and unpreserved (neat) urine have been validated. 5. The BD ProbeTec Urine Preservative Transport (UPT) Kit contains NAP Guard™ (≥742.5 mM K2EDTA). NAP Guard may be irritating to the eyes, skin and respiratory system. In case of contact with eyes, rinse opened eye immediately with plenty of water and seek medical advice if symptoms persist. After contact with skin, wash immediately with plenty of soap and water. If inhaled, seek medical attention in case of problems. 6. Laboratories may validate other swab or urine collection and transport devices for use with the BD ProbeTec ET CT/GC assays according to the "Verification and Validation Procedures in the Clinical Microbiology Laboratory," Cumitech 31, B.L. Elder et al., American Society for Microbiology, Washington D.C., February, 1997. 7. Do not test the CT/GC Diluent tube from the BD ProbeTec ET CT/GC Amplified Assay Collection Kits if received in the laboratory without the swab present. A false negative test result may occur. 8. Use only the BD ProbeTec ET Pipettor and BD ProbeTec ET Pipette tips for the transfer of processed samples to Priming Microwells and the transfer of samples from the Priming Microwells to the Amplification Microwells. 9. Do not interchange or mix kit reagents from kits with different lot numbers. 10. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions" 11-14 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. 11. Use established laboratory practices when disposing of used pipette tips, sample tubes, Priming Microwells and other disposables. Discard disposables carefully. Seal and dispose of waste containers when they are 3/4 full or daily (whichever comes first). 12. The BD ProbeTec ET Diluent (CT/GC) and CT/GC Diluent tube contain dimethyl sulfoxide (DMSO). DMSO is harmful by inhalation, contact with skin or if swallowed. Avoid contact with eyes. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with skin, wash immediately with plenty of water. 13. Reagent pouches containing unused Priming Microwells and Amplification Microwells MUST be carefully resealed after opening. Verify that a desiccant is present prior to resealing the reagent pouches. 14. The plate containing the Amplification Microwells MUST be properly sealed with the Amplification Sealer prior to moving the plate from the BD ProbeTec ET Priming and Warming Heater to the BD ProbeTec ET Instrument. Sealing ensures a closed reaction for amplication and detection and is necessary to avoid contamination of the instrument and work area with amplification products. Do not remove sealing material from microwells at any time. 15. Priming Microwells with residual fluid (after transfer of fluid from the Priming Microwells to the Amplification Microwells) represent a source of target contamination. Carefully seal Priming Microwells with plate sealer prior to disposal. 16. To prevent contamination of the work environment with amplification products, use the disposal bags provided in the Reagent Packs to dispose of tested Amplification Microwells. Make sure the bags are properly closed before disposal. 17. Although dedicated work areas are not required because the BD ProbeTec ET design reduces the possibility of amplicon contamination in the testing environment, other precautions for controlling contamination, particularly to avoid contamination of specimens during processing, are necessary. 18. Because of the potential for false positivity with some non-gonococcal Neisseria found in the respiratory tract (see "Limitations of the Procedure," #19), contamination of reagents and specimens with respiratory aerosols should be avoided. 19. CHANGE GLOVES after removing and discarding caps from lysed samples and controls to avoid crosscontamination of specimens. If gloves come in contact with specimen or appear to be wet, immediately change gloves to avoid contaminating other specimens. Change gloves before leaving work area and upon entry into work area. 20. In the event of contamination of the work area or equipment with samples or controls, thoroughly clean the contaminated area with ELIMINase, DNA AWAY or 1% (v/v) sodium hypochlorite with Alconox and rinse thoroughly with water. Allow surface to dry completely before proceeding. 21. In case of a spill on the Lysing Rack: The rack may be immersed in ELIMINase, DNA AWAY or 1% sodium hypochlorite with Alconox for 1 - 2 min. Do not exceed 2 min. Thoroughly rinse the rack with water and allow to air dry. 22. Clean the entire work area – counter tops and instrument surfaces – with ELIMINase, DNA AWAY or 1% (v/v) sodium hypochlorite with Alconox on a daily basis. Thoroughly rinse with water. Allow surfaces to dry completely before proceeding with additional testing. 23. Contact Technical Services in the event of an unusual situation, such as a spill into the BD ProbeTec ET instrument or DNA contamination that cannot be removed by cleaning. | |||||||||||
Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.
