November 2015 Product Focus – Rapid Testing

Chembio’s DPP HIV 1/2 Assay

Chembio’s CLIA-waived DPP HIV 1/2 Assay detects HIV antibodies in oral fluid or blood and uses the company’s patented Dual Path Platform (DPP) technology, which offers excellent sensitivity and specificity. The product’s unique SampleTainer specimen collection bottle is a safe, closed system for collecting potentially infectious samples. The oral swab is soft and patient-friendly. The DPP HIV 1/2 Assay is FDA-approved and CLIA-waived. Chembio’s DPP HIV 1/2 and HIV 1/2 STAT-PAK Assays are both manufactured in the United States.

For more information, please visit: http://chembio.com/products/human-diagnostics/dpp-hiv-12-assayx/

Hemosure’s One-Step Immunological Fecal Occult Blood Test

Hemosure’s One-Step Immunological FOB Test (iFOBT) for colorectal cancer screening employs a combination of monoclonal and polyclonal antibodies to selectively identify hemoglobin in test samples with a high degree of sensitivity, with the objective of detecting and diagnosing diseases that result in the lower GI bleeding, such as colorectal cancers and large adenomas that bleed. This allows for cancer detection at an early stage and thus reduces the mortality. Positive results for even minimally elevated levels of hemoglobin can be seen in the test as early as five minutes. Tests have a 24-month expiration from the date of manufacture when kept at room temperature. With higher sensitivity and specificity and no dietary or drug restrictions, the iFOBT lowers the rate of false positives or negatives due to greater patient compliance and results remaining unaffected by animal blood or iron reagents.

For more information, please visit: http://hemosure.com/hospital-laboratory/products/

Randox’s range of rapid tests

Randox offer a wide range of high-quality rapid tests which include Anti-Streptolysin O (ASO); C-Reactive Protein (CRP); Rheumatoid Factor, Pregnancy Test; and Syphilis (RPR and TPHA). These tests are based on agglutination, immuno-dot, immuno-chromatographic or immuno-filtration techniques. Each test is quick and easy to perform (two minutes to two hours) requiring little or no additional equipment, and is designed for use with an individual or limited number of samples, which make the tests more economical than ELISAs in low-throughput laboratories. Randox rapid tests can also be stored at room temperature for extended periods of time. These rapid tests provide same-day results, enabling timely treatment interventions.

For more information, please visit: http://www.randox.com/reagents/rapid-tests-serology

Roche’s cobas Influeza A/B Test

Roche has announced that the FDA has granted CLIA waiver for the cobas Influenza A/B test for use on the cobas Liat System. This CLIA-waived, real-time PCR test can detect influenza A and B in ~20 minutes. Coupled with the CLIA waived cobas Strep A test, the cobas Influenza A/B test can now be used by healthcare providers in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics, and other healthcare facilities. The CLIA-waived cobas Influenza A/B test for the cobas Liat PCR System offers an effective, new diagnostic tool to clinicians for the upcoming flu season and provides fast diagnosis and treatment for patients in primary and urgent care settings.

For more information, please visit: https://usdiagnostics.roche.com/en/instrument/cobas-liat.html

Thermo Scientific’s UltraVision Quanto Detection System

Thermo Scientific’s UltraVision Quanto offers innovative micro-polymer technology that provides speed and economy while achieving high sensitivity and enhanced reactivity. Primary incubation times for most prediluted antibodies are at 20 minutes. Polymer incubation time is only 10 minutes. Cytoplasmic, membrane, and even challenging nuclear markers yield ideal results. The UltraVision Quanto system enhances the detection of antigens expressed at low levels without the background staining of traditional label polymer kits. The UltraVision Quanto system provides an IHC detection system that combines speed, economy, and sensitivity to achieve superior and consistent results.

For more information, please visit: http://www.thermoscientific.com/en/product/ultravision-quanto-detection-system-hrp-dab.htmt

Verax Biomedical’s Platelet PGD Test

Verax Biomedical recently gained FDA clearance for expanded platelet safety measure testing indications. Verax Platelet PGD test is thus cleared for all commonly available U.S. platelet types. It is the company’s first product for the detection of bacterial contamination in platelets and has been cleared by the FDA as a Safety Measure for leukoreduced apheresis platelets within 24 hours prior to transfusion. Use of the PGD test within 24 hours of transfusion offers the opportunity to interdict and prevent the transfusion of a proportion of severely contaminated units that pose a serious risk to patient safety. The test is also FDA cleared as a QC test for leukoreduced and non-leukoreduced whole blood-derived platelets pooled within four hours of transfusion.

For more information, please visit: http://www.veraxbiomedical.com/products/platelet-pgd-test.asp

Hardy Diagnostics PYR Test Kit

Hardy Diagnostics’ new PYR Test Kit is a colorimetric method for the presumptive identification of group A streptococci, group D enterococci, some species of coagulase-negative staphylococci, and other genera of Enterobacteriaceae in an easy-to-use card format. It’s a rapid method for detecting enzymatic activity in certain groups of bacteria. The new format is a simplified mechanism for performing multiple tests simultaneously. Quick and convenient, the new card format is easier to handle than individual disks and presents a cost-effective aid in the rapid detection of potentially pathogenic bacterial infections in healthcare settings. The new format includes filter paper impregnated with l-pyroglutamic acid betanaphthylamide and is used in conjunction with the PYR Reagent, p-dimethylaminocinnamaldehyde, to yield a bright pink to cherry red color on PYR positive strains. The card can be used to perform three tests at a time and aids in the presumptive identification of pure cultures.

For more information, please visit: https://catalog.hardydiagnostics.com/cp_prod/product/z175-pyr-test-kit-100-tests-with-20ml-chromogenic-developer-on-paper-disks-by-hardy-diagnostics-prefer-to-ship-ground-test-disks-strips-reagents

Carolina Liquid Chemistries Corp.

Carolina Liquid Chemistries Corp. (CLC) recently completed its branded line of chemistry analyzers, which completes its all-new family of instruments. The FDA cleared the CLC1600 as part of the CLC6410 family for use with a variety of methods. CLC, known for providing clinical laboratories with instruments and over 80 reagents that aid in diagnosing and treating patients, now offers the CLC720i, CLC800, CLC1600, and the CLC6410. The CLC1600 meets the needs of a high-volume clinical laboratory, while offering current technology typically not available on older analyzers. The CLC1600 produces up to 900 photometric tests per hour and 1200 tests per hour when including electrolytes. Advanced features of the CLC1600 include user-friendly, intuitive Windows 7 Pro software and sample wheel with 140 positions. The CLC1600 can hold 66 two-part reagents or 132 single-part reagents. The analyzer accommodates reagents with up to four parts. This instrument can save time and decrease operational cost, while increasing productivity.

For more information, please visit: http://carolinachemistries.com/CLC/index.cfm/hurl/idsPageID=133/Type=/Carolina-Liquid-Chemistries-Home