April 2016 Product Focus – Rapid Testing (plus New Products)

By: MLO Staff   

Alere’s Alere i

MLO201604-ProductFocus_Alere_i_instrumentAlere i is a CLIA-waived point-of-care molecular platform. As a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases, this isothermal nucleic acid amplification technology provides molecular results in minutes, allowing for effective clinical decisions sooner. The Alere i features an intuitive and user-friendly touch screen system, requiring minimal training and fitting easily into any healthcare setting.


Alere’s Determine

MLO201604-ProductFocus_AlereComboAlere Determine HIV-1/2 Ag/Ab Combo is an FDA approved 4th generation rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. This test is CLIA- Waived for fingerstick whole blood. Determine has a test procedure of three simple steps, flexibility of multiple sample types, and proved overall clinical sensitivity of 99.9 percent.


Chembio’s DPP HIV 1/2 Assay

MLO201604-ProductFocus_ChembioDPPChembio has developed a NEXT GENERATION DPP assay using patented DPP technology for the rapid detection of HIV 1 and HIV 2 antibodies in oral fluid and all blood matrices. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test. The assay provides a patient-friendly swab for oral fluid sampling or a loop which requires only 10 µL of blood. The DPP SampleTainer specimen collection bottle is a safe, closed system for handling potentially infectious blood and oral fluid samples. FDA-approved and CLIA-waived for fingerstick and venous whole blood.


Meridian Bioscience’s ImmunoCard STAT! HpSA

MLO201604-ProductFocus_MeridianThe Meridian Bioscience ImmunoCard STAT! HpSA is a stool antigen test for the detection of H. pylori. HpSA results aid in the definitive diagnosis of active H. pylori infection, help in monitoring response during treatment, and can confirm eradication. The stool antigen test can be used with patients of all ages. It is patient-friendly as patients do not need to be off proton pump inhibitors, H2 blockers, or bismuth before testing.
Meridian Bioscience


Randox’s Rapid Tests

MLO201604-ProductFocus_Randox-HHH2025-ASORandox offers a wide range of high quality rapid tests which include: Anti-Streptolysin O (ASO); C-Reactive Protein (CRP); Rheumatoid Factor; Pregnancy Test; and Sypilis (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. Randox Rapid Tests can also be stored at room temperature for extended periods of time. The same-day results that rapid tests provide enable timely treatment interventions.




Roche’s cobas Liat System

MLO201604-ProductFocus_RocheThe U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test for use on the cobas Liat System. It is a CLIA-waived, real-time polymerase chain reaction (PCR) test that detects 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.





Sekisui Diagnostics’ OSOM Portfolio

MLO201604-ProductFocus_SekisuiSekisui Diagnostics has launched three new rapid tests to the OSOM portfolio. Providing accurate results with minimal hands-on time, OSOM Ultra Flu A&B and OSOM Ultra hCG Combo complement the existing Flu and hCG product lines, while the OSOM iFOB provides a new diagnostic option for fecal occult blood testing.
Sekisui Diagnostics



New Products

Inverted microscope

MLO201604-NewProduct_Olympus-CKX53The CKX53 is a next-generation inverted microscope designed for fast, efficient cell culture checking and documentation. Its imaging capabilities and user-friendly design reduce operator fatigue and improve cell culture throughput. The microscope provides excellent clarity and resolution, with a newly developed integrated phase contrast system that enables the operator to view samples at 4x, 10x, 20x, and 40x, without exchanging or re-centering the ring slit. Brightfield imaging is improved with an energy-efficient, long-life LED light source. In addition, the color temperature of the LEDs is optimized for cell culture observation to enhance color reproducibility when raising or lowering the brightness level. The microscope is 20 percent lighter than previous models so it can be moved as needed and placed on a sterile bench when aseptic conditions are required.


Micromanipulator with joystick

MLO201604-NewProduct_EppendorfThe TransferMan 4m micromanipulator features a DualSpeed joystick and functions to help speed up and facilitate the handling of sensitive samples. The micromanipulator therefore helps minimize exposure of sensitive cells to trauma or adverse conditions like room temperature or removal from CO2 atmosphere. The micromanipulator is a tool for applications, such as ICSI, PGD, and related techniques. In conjunction with the manual microinjectors of the Eppendorf CellTram family, it forms an ideal system for demanding cell manipulation procedures. The TransferMan 4m is classified in the United States as an assisted reproduction micromanipulator and microinjector medical device under 21 CFR 884.6150.


X-well slide cell culture system

MLO201604-NewProduct_SarstedtA new lumox x-well cell culture chamber with a 50µm ultra-thin, gas-permeable film base that combines imaging with superior cell growth. Compared to plastic or glass bases, the gas-permeable lumox film provides more effective gas exchange and homogeneous cell growth. It shows virtually no autofluorescence and higher light transmission for consistently high assay sensitivity and excellent microscopy and fluorescence-based imaging. The film is chemically resistant to a multitude of fixatives and stains and can be easily cut for cell isolation or storage after fixation and staining.


Portable all-in-one printer

MLO201604-NewProduct_PrimeraThis device is a small, lightweight and portable all-in-one printer. It’s perfect for people who need to print, scan, and copy while on-the-go. Its functionality to print, scan, and copy matches any full-size all-in-one printer. At just 2.6 lbs. (1.2kg) and about the size of a hardcover book, Primera Trio fits just about anywhere.

April 2016 Product Focus – Rapid Testing (plus New Products)
MLO Staff
By: MLO Staff
Medical Laboratory Observer (MLO) is the peer reviewed management source for lab professionals since 1969.