The Simplexa HSV 1 & 2 direct molecular test running on the 3M Integrated Cycler is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis. The test uses a proprietary process that eliminates nucleic acid extraction, so clinicians can expect results within about an hour after providing a specimen for testing. Encephalitis is an inflammation of the brain oft en caused by the herpes simplex or other viruses. The Infectious Diseases Society of America (IDSA) recommends herpes simplex PCR testing on all CSF specimens in patients with encephalitis. HSV encephalitis occurs in all ages and during all seasons, with HSV-1 encephalitis more common in adults and HSV-2 encephalitis more common in newborn infants. Accurate determination of the virus-causing encephalitis can influence treatment decisions and outcomes. The moderate complexity categorization of the Simplexa HSV 1 & 2 Direct molecular test significantly broadens the potential clinical access to the technology. Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician’s offices, community hospitals, health clinics and integrated delivery networks. These facilities typically lack the personnel and technology to perform high complexity molecular diagnostic tests. Since the test can be performed in these moderate complexity labs, patient results may be obtained readily to help speed therapeutic decisions. Simplexa tests, designed for use on the 3M Integrated Cycler, employ realtime polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes. Simplexa HSV 1 & 2 Direct showed strong performance in clinical studies, with 100% and 98% sensitivity for detection of HSV-1 and HSV-2 respectively. The test was CE-marked for distribution to more than 30 countries in Europe in November 2013.
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Perfect for LN2 freezing and long-term cryogenic freezer storage, the computer printable durable label for ultra low temperatures provides immediate permanent adhesion to all cyrovials, tubes and liquid straws stored down to -196ºC. Available in any format including ‘cap & tube’ label sets, they allow variable data (lot numbers, barcodes etc) to be added ‘in minutes’ straight from a standard laser, inkjet or thermal transfer printer, saving time and eliminating the risk of smudged or illegible handwritten data, providing reliable sample identification for liquid nitrogen storage.

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Biohit is introducing an improved liquid method for H. pylori detection from biopsy samples, the Helicobacter pylori UFT300 quick test. The detection is based on the detection of bacterial urease activity in gastric biopsy specimens. A gastric mucosa colonized by H. pylori is invariably inflamed, and can lead to atrophic gastritis, which has been linked with peptic ulcer and gastric cancer, two of the most important diseases of upper gastrointestinal tract. The quick test is easy to storage and perform and results are ready in a few minutes enabling diagnosis and reporting at the point of gastroscopy.
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Specifically designed to replace multiple instrument specific controls the new Liquid Assayed Chemistry Premium Plus control from Randox uniquely combines 100 analytes including proteins, lipids, cardiac markers, drugs and immunoassays in a single vial to help clinical laboratories reduce valuable time and costs without compromising on performance or quality.

As a third party control laboratories are assured of a truly unbiased, independent assessment of performance.  With the added advantages associated with liquid controls and the availability of assayed target values for a range of platforms this control will enhance performance and productivity in any clinical laboratory.

• Liquid for user convenience
•  Assayed target values
• Comprehensive analyte menu
• Three clinically significant levels
• Seven day open vial stability

For more information please click here
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A multiparametric indirect immunofluorescence assay (IFA) for the simultaneous detection of infections with different old and new world hantaviruses has been developed and evaluated in an international study published in PLOS Neglected Tropical Diseases in April 2013. The IFA utilizes BIOCHIP Mosaics, with each substrate consisting of cells infected with one of the virus types Hantaan (HTNV), Puumala (PUUV), Seoul (SEOV), Saaremaa (SAAV), Dobrava (DOBV), Sin Nombre (SNV) or Andes (ANDV). In the evaluation study, 184 confirmed seropositive sera from six diagnostic centres worldwide and 89 control sera were analysed for specific antibodies of immunoglobulin classes IgG and IgM against hantaviruses using the IFA. The assay demonstrated an overall sensitivity of 100% for all serotypes with the exception of SNV (96%) and an overall specificity of at least 98% for each serotype. 99% of the patient sera exhibited IgG antibodies and 71% IgM antibodies. Notably, the IFA was able to distinguish PUUV and ANDV infections from those with murinae-borne hantaviruses such as DOBV and SEOV, thus providing useful additional information for therapeutic decision making. The authors note that many hantavirus patients are still clinically misdiagnosed as having influenza-like infections, renal failure or idiopathic acute respiratory distress syndrome. Accurate diagnosis is, however, essential given the mortality rates of up to 35% from hantavirus syndromes. The misdiagnosis rate combined with the increasing number of hantavirus infections worldwide demonstrates the need for simple and reliable tests which allow detection of all clinically relevant hantavirus serotypes. Analysis of specific antibodies is the method of choice for diagnosing hantavirus infections. By combining the most important pathogenic hantaviruses in one assay, this IFA system is suited to detect any hantaviral infection worldwide. The test is particularly suitable for serodiagnostic screening in regions where multiple serotypes are endemic.
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