New Infectious Disease Assays
Lyme, Syphilis, and ToRCH IgG assays
The AtheNA Multi-Lyte® menu, from Alere, Waltham, Mass, has recently expanded to include three new FDA-cleared infectious disease assays: Lyme, Syphilis, and ToRCH IgG. Borrelia VlsE-1/pepC10 is intended for use as a first-tier test to detect qualitative levels of B. burgdorferi antibodies. Combining the VlsE-1 IgG and pepC10 IgM antigens provides an increased sensitivity for detecting early Lyme disease. ToRCH IgG detects IgG antibodies to five individual antigens including Toxoplasma gondii, Rubella, and Cytomegalovirus as an aid in the assessment of serological status, and, for sexually active adults and expectant mothers, as an aid for diagnosing HSV-1 and HSV-2. Treponema pallidum IgG detects IgG antibodies to the T. pallidum bacteria as an aid in the diagnosis of Syphilis infection.
Protein Spin Purification Kit
Available with nickel- or cobalt-chelating resin
The HOOK™ 6X His Protein Spin Purification kit from G-Biosciences, Maryland Heights, Mo, is used for the rapid purification of soluble, His-tagged proteins. It is available with either nickel-chelating resin or cobalt-chelating resin for immobilized metal affinity chromatography. Cobalt chelating resin has a lower binding affinity for 6X His tags, compared to nickel chelating resin, which results in less nonspecific binding and may result in slightly lower yields. The spin format is optimized to yield ~1 mg/50 mL culture of soluble His tagged protein, with a purity of 80% to 90%, dependent on expression levels, resin type, conformation, and solubility characteristics of the protein.
Solution to treat, clean, and prepare protein samples
PAGE-Perfect™ from G-Biosciences, Maryland Heights, Mo, removes all interfering agents from protein solutions. Samples can be reproducibly resolved on SDS-polyacrylamide gels with higher band visibility, greater protein resolution, and no band distortion. PAGE-Perfect offers a method for treating, cleaning, and preparing protein samples for loading on electrophoresis gels. It is also available to clean and concentrate protein samples that give poor protein spot resolution during 2D electrophoresis.
Nasal, throat, and cheek swab sample kits
Fluoresentric Inc, Park City, Utah, releases the Direct-2-PCR™ sample kits for nasal, throat, and cheek swab diagnostic health tests. The sample-preparation method requires less than 1 minute of hands-on time per sample. It also reduces pipetting steps per sample and lowers plastic consumable costs by 25% to 50%. The kit produces PCR-ready DNA and RNA simultaneously. The resulting sample is ready for any type of genetic test ordered for that sample: viral or host genotyping, pathogen detection, as well as quantitative testing applications. The prepared samples are compatible with one-step real-time PCR, two-step real-time PCR, and DNA conventional and real-time PCR amplification chemistries and instruments.
Detection of Trichomonas vaginalis and Trichomonas foetus
ViroStat Inc, Portland, Me, introduces a set of new monoclonal antibodies, which may aid in their rapid detection of Trichomonas vaginalis and Trichomonas foetus. Validated applications of these antibodies include immunoflourescence staining, ELISA, and lateral flow. Diagnosis of these parasites commonly involves visual examination of microscopic smears (wet mount). More recently, culture methods have been introduced. However, these can take several days for a result.
Real-time PCR in vitro diagnostic test
The Detect-Ready MRSA kit from Molecular Detection Inc, Wayne, Pa, is a qualitative real-time PCR in vitro diagnostic test for the direct detection of MRSA, MSSA, and methicillin-resistant non-S. aureus nasal colonization to aid in the prevention and control of these infections in hospitals and other health care settings. Detect-Ready kits are off-the-shelf room temperature-stabilized and require no refrigeration. Detect-Ready kits are compatible with multiple real-time PCR platforms currently found in clinical laboratories, including the Roche LightCycler®, QIAGEN Rotor-Gene®, and Cepheid SmartCycler®. The Detect-Ready MRSA panel has received the CE mark certification for sales in the European Union. It is currently available in the UK, Germany, Ireland, Switzerland, Spain, Austria, and Australia.
Molecular Detection Inc
Products for newborn, pregnancy screening applications
Cerilliant Corp, Round Rock, Tex, introduces 14 certified Snap-N-Spike® solutions of hormones monitored by LC-MS/MS for pregnancy or newborn screenings. New products for newborn screening applications include 1.0 mg/mL concentrations of 178-Hydroxyprogesterone, Cortisol, 11-Deoxycortisol, Dehydroepiandrosterone (DHEA), and DHEA 3-sulfate sodium salt in methanol, and 100 µg/mL concentrations of 21-Deoxycortisol and the internal standard DHEA-D5 in methanol. New certified spiking solutions for pregnancy or female hormones diagnostic testing consists of 1.0 mg/mL concentrations of Estrone, Estriol, and 178-Ethynylestradiol in methanol and 17ß-Estradiol and Progesterone in acetonitrile with 100 µg/mL concentrations of internal standards 17ß-Estradiol-D5 and Progesterone-D9 in acetonitrile. These certified solutions are suitable for critical quantitative applications in clinical and endocrinology settings. The shelf-stable format allows laboratories to eliminate weighing operations and provides the ability to spike a certified concentration of analyte into their matrix of choice at the concentration desired just before use.
Measures intact parathyroid hormone levels
The VITROS® intact Parathyroid Hormone (iPTH) Assay from Ortho Clinical Diagnostics, Rochester, NY, has received FDA 510(k) clearance. The iPTH Assay measures intact parathyroid hormone levels and utilizes one protocol for both routine and intraoperative testing with results available in 18 minutes. It is designed to be run in a fully automated, random access format on the VITROS ECi/ECiQ and 3600 Immunodiagnostic Systems, and can also be run on the VITROS 5600 Integrated System to combine clinical chemistry, routine, and infectious disease immunoassay testing on a single platform. Measuring intact parathyroid hormone levels aids in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
Ortho Clinical Diagnostics
HIV Test for Newborns
High-sensitivity, low-cost HIV testing
HiSens™ HIV, the new HIV-1 p24 Ag Ultra kit from PerkinElmer Life Sciences, Waltham, Mass, is a solution for high-sensitivity, low-cost HIV testing. Due to the absence of such tests, many infants born of HIV-positive mothers have themselves been infected with the disease only after birth—for example, as a result of breast feeding. Reliable testing at birth means that those children identified as HIV negative can be protected from infection later. The presence of p24 antigen correlates well with viral replication and is potentially suitable for detection of HIV-1 in newborns since it is not dogged by the problem of false positives caused by antibodies received from an infected mother. The test is available for research or testing purposes only.
PerkinElmer Life Sciences