(155 days)
The BD ProbeTecT™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay, when tested with the BD Viper™ System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae 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 (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath™ Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePath™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
The BD ProbeTec GC O* Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently-labeled detector probe. The reagents for SDA are dried in two separate disposable microwells: the Priming Microwell contains the amplification primers, fluorescently-labeled detector probe, nucleotides and other reagents necessary for amplification, while the Amplification Microwell contains the two enzymes (a DNA polymerase and a restriction endonuclease) that are required for SDA. The BD Viper™ System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents. After a brief incubation, the reaction mixture is transferred to a corresponding, pre-warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally-controlled fluorescent readers. The presence or absence of N. gonorrhoeae DNA is determined by calculating the peak fluorescence (Maximum Relative Fluorescent Units (MaxRFU)) over the course of the amplification process and by comparing this measurement to a predetermined threshold value.
In addition to the fluorescent probe used to detect amplified N. gonorrhoeae target DNA, a second labeled oligonucleotide is incorporated in each reaction. The Extraction Control (EC) oligonucleotide is labeled with a different dye than that used for detection of the N. gonorrhoeae -specific target and is used to confirm the validity of the extraction process. The EC is dried in the Extraction Tubes and is rehydrated upon addition of the specimen and extraction reagents. At the end of the extraction process, the EC fluorescence is monitored by the BD Viper System and an automated algorithm is applied to both the EC and N. gonorrhoeae -specific signals to report results as positive, negative, or EC failure.
BD ProbeTec™ Neisseria gonorrhoeae (GC) Q* Amplified DNA Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (BD SurePath Specimens) |
|---|---|---|
| Clinical Performance | ||
| Sensitivity | Sufficient for diagnosis, as demonstrated by comparison to PIS. | Asymptomatic: 100.0% (32/32) (95% C.I.: 89.1% - 100.0%) |
| Symptomatic: 100.0% (19/19) (95% C.I.: 82.4% - 100.0%) | ||
| Total: 100.0% (51/51) (95% C.I.: 93.0% - 100.0%) | ||
| Specificity | Sufficient for diagnosis, as demonstrated by comparison to PIS. | Asymptomatic: 99.8% (1123/1125) (95% C.I.: 99.4% - 100.0%) |
| Symptomatic: 100.0% (539/539) (95% C.I.: 99.3% - 100.0%) | ||
| Total: 99.9% (1662/1664) (95% C.I.: 99.6% - 100.0%) | ||
| PPV | (Not explicitly defined, but results indicate high PPV) | Asymptomatic: 93.5% |
| Symptomatic: 100.0% | ||
| Total: 96.9% | ||
| NPV | (Not explicitly defined, but results indicate high NPV) | Asymptomatic: 100.0% |
| Symptomatic: 100.0% | ||
| Total: 100.0% | ||
| Analytical Performance | ||
| Limit of Detection (LOD) | Detection of N. gonorrhoeae at low concentrations. |
§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).