BD ProbeTec Amplified DNA Assays
Detect Chlamydia trachomatis and Neisseria gonorrhoeae
BD Diagnostics, Franklin Lakes, NJ, launches its BD ProbeTec™ Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Qx Amplified DNA assays. Running these molecular assays on the BD Viper™ system with XTR Technology enables labs to process a higher volume of tests automatically from swabs, LBC, or urine samples. The fully automated system can process up to 736 patient samples in a single work shift and requires minimal hands-on time for setup, sample extraction, workflow, and maintenance. When tested with the Viper system, the assays use ferric oxide, FOX™ Extraction, and strand displacement amplification technologies for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA. Menu under development includes HSV and a Vaginitis Panel.
BD Diagnostics
(800) 638-8663
www.bd.com
digene HPV Test
Based on Hybrid Capture 2 technology
The digene HPV test, from QIAGEN, German Town, Md, is based on the company’s proprietary Hybrid Capture® 2 technology. The technology uses probes that specifically target DNA from bacteria or viruses such as HPV, Chlamydia, and gonorrhea. If bacteria or a virus is present in the sampled cells, these probes find the target DNA when added to the sample and hybridize (bind) to it. These hybrids (target DNA bound by the probe) are then captured to allow detection. In this process, special antibodies and enzymes are added to the sample that—in the presence of captured hybrids—cause the emission of light that is measured by a computerized laboratory instrument.
QIAGEN
www.qiagen.com
OSOM Trichomonas Rapid Test
Provides results in 10 minutes or less
The OSOM® Trichomonas Rapid Test, from Genzyme Diagnostics, San Diego, is a CLIA-waived rapid test for the detection of Trichomonas vaginalis. Included in the CDC and ACOG guidelines, it is the only CLIA-waived rapid test for the diagnosis of Trichomonas vaginalis. The test provides objective results in 10 minutes or less with less than 1 minute of hands-on time. Antigen based, the test does not require organism motility in order to be accurate. It features a sensitivity of 83% versus culture.
Genzyme Diagnostics
(800) 332-1042
www.genzymediagnostics.com
RealTime Chlamydia/Gonorrhea Assay
Simultaneously detect gonorrhea and Chlamydia
Abbott, Des Plaines, Ill, now offers both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 system, a new, sensitive molecular diagnostic test and instrument to simultaneously detect gonorrhea and Chlamydia, including a new variant strain of Chlamydia recently discovered in Sweden. The test and instrument must be used together as a system for the detection of CT/NG from multiple specimen types, including urine, urethral, vaginal, and endocervical swabs.
Abbott
(800) 553-7042
www.abbott.comm
Qualitative Anti-HCV Immunoassay Test
The Elecsys Anti-HCV Immunoassay, from Roche Diagnostics, Indianapolis, is intended for in vitro qualitative determination of total antibodies to hepatitis C virus in human serum or plasma. The 18-minute test is designed for use with Roche’s electrochemiluminescence (ECL) technology and for three platforms: the stand-alone cobas e 411 analyzer for low-volume testing; and the cobas e 601 and MODULAR ANALYTICS E 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for mid-volume and high-volume testing, respectively. Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease.
Roche Diagnostics
(317) 521-2000
www.roche.com
APTIMA COMBO 2 Assay
Detects Chlamydia/Gonorrhea from urine and swab specimens
The APTIMA COMBO 2 Assay, from Gen-Probe, San Diego, utilizes target capture for the in vitro qualitative detection and differentiation of rRNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in endocervical and male urethral swab specimens, and in female and male urine specimens. The assay is a target amplification nucleic acid amplification test that can be run on the TIGRIS® DTS® Automated Analyzer or semiautomated instrumentation as specified. The test provides two results from one sample, increasing lab efficiency with single-tube testing. It is the only assay with urine specimen sensitivity equivalent to swab specimen. Additionally, excellent sensitivity and specificity has been demonstrated with vaginal swabs and Cytyc ThinPrep liquid Pap specimens.
Gen-Probe
(800) 523-5001
www.gen-probe.com
TREP-SURE EIA Screen
Enzyme immunoassay for Syphilis
Phoenix Bio-Tech Corp, Mississauga, Ontario, Canada, offers the TREP-SURE™ EIA Screen, a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema pallidum (Syphilis) antibodies in human serum or plasma. The assay detects all isotypes, essential for early detection, and features high sensitivity for all stages of Syphilis disease (> 99% in active Syphilis, > 90% in Darkfield Positive patients). Its specificity is > 99% with no cross-reactions, and the assay has high tolerance for potentially interfering substances such as lipids or hemoglobin. Requiring no predilution, 100 µL of sample can be added to the well directly from centrifuged blood clots. To reduce variations due to changes in temperature, incubations are carried out at 37ºC. Results can be fully integrated in a LIS through bar coding.
Phoenix Bio-Tech Corp
(905) 826-6330
www.phoenixbiotech.com
