digene High-Risk HPV hc2 Test
Detects all 13 high-risk HPV types
The digene High-Risk HPV hc2 Test, from QIAGEN, Germantown, Md, is an in vitro nucleic acid hybridization assay utilizing antibody capture and qualitative chemiluminescent signal detection of HPV types based on signal amplification. The test is suitable for high- or low-volume testing applications. The test uses an RNA probe cocktail to detect all 13 high-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/ 59/68), which are highly carcinogenic. It analyzes HPV DNA high-risk groups in cervical specimens, and it has been approved for use with hc2 DNA Collection Device, HC Cervical Sampler, Specimen Transport medium, and Cytyc ThinPrep Pap Test PreservCyt Solution. This test has the highest clinical sensitivity proven by extensive clinical validation and is both FDA-approved and CE-marked.
Cervista HPV Tests
Includes HPV high-risk and HPV 16/18 tests
Hologic Inc, Bedford, Mass, has received FDA premarket approval for both the Cervista™ HPV high-risk (HR) and the Cervista HPV 16/18 tests. Cervista HPV HR is designed to detect the 14 high-risk types of HPV known to cause cervical cancer and has been approved to screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The Cervista HPV 16/18 test genotypes HPV types 16 and 18 and is approved to be used conjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology results to assess the presence or absence of specific high-risk HPV types. Both tests have been approved to be used in combination with other testing to screen women 30 years and older to assess the presence or absence of high-risk HPV types.
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.
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