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| NorDx, (Northern Diagnostic Laboratories), the largest reference laboratory in the state of Maine and a member of MaineHealth, today announces the acquisition of Sysmex® XN-Series Automated Hematology Analyzers. |
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| Because of their low sensitivity, enzyme immunoassay (EIA) tests are no longer recommended for detection of C. difficile toxin in stool specimens. Recent reports indicate that molecular assays like the polymerase chain reaction (PCR) provide sensitivities and specificities comparable to toxigenic culture, the current "gold standard", and provide significantly shorter turnaround times. |
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| Effective April 2011, NorDx will begin using version 2.0 of the IVD HBV real-time PCR test for quantitative HBV viral load testing. The expanded quantitative range of the assay is 20 to 170,000,000 IU/ml. |
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| The Philadelphia chromosome results from a translocation on [t (9;22)(q34;q11.2)] that fuses the ABL proto-oncogene on chromosome 9 to the BCR (breakpoint cluster region) gene on chromosome 22. In chronic myelogenous leukemia (CML), the great majority of breakpoints occur within the 5.8 Kb major breakpoint cluster region (M-BCR). The BCR-ABL transcript is translated into a 210kD fusion protein (p210). This BCR-ABL fusion transcript is quantified relative to the normal ABL transcripts using real time RT- PCR. |
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| The Flu A/B RT-PCR screen test detects and differentiates between Influenza A and B viruses. If Influenza A virus is detected, the test will reflex to Influenza A subtyping to differentiate between the novel 2009 H1N1 and seasonal Influenza A viruses (H1 and H3). Molecular-based assays demonstrate higher sensitivity and specificity than other screening methods. |
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| HPV genotyping will be performed using the Cervista HPV 16/18 IVD test. HPV genotyping can be ordered on patients that have tested positive for the HPV high risk screen (HPVHR, HPVH, or HPVHO). |
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| The Centers for Medicare and Medicaid Services (CMS) has issued through their National Coverage Determinations (NCDs) guidelines pertaining to lipid testing. They state that: The serum LDL cholesterol concentration may be calculated using the Friedenwald formula (LDL=total cholesterol - HDL -triglycerides/5). However, if the triglyceride level is greater than 400 mg/dL, the LDL should be measured directly. Further, the calculation may not accurately determine the LDL level in alcoholic patients. These patients may also require direct measurement of the serum LDL. |
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| The National Kidney Disease Education Program (NKDEP) is an initiative of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), U.S. Department of Health & Human Services (DHHS). The NKDEP strongly encourages clinical laboratories to automatically report eGFR when serum creatinine is reported. An eGFR calculated from serum creatinine is a practical way to detect, evaluate, and manage people with chronic kidney disease (CKD), especially people with risk factors for CKD—diabetes, hypertension, cardiovascular disease, or family history of kidney disease—in whom CKD might otherwise go undetected and untreated. |
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| Effective January 1, 2005, the volume of whole blood necessary for the performance of Factor V Leiden testing is reduced to a minimum of 0.5 mL of whole blood in an EDTA tube. |
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| NorDx will perform HIV-1 RNA viral load testing using the Roche COBAS® AmpliPrep/ COBAS® TaqMan® HIV-1 Test, version 2.0. The updated version of this RT-PCR assay offers increased sensitivity and improved ability to quantify HIV-1 groups M and O. The quantitative range of this updated version of the assay is 20 to 10,000,000 copies/ml. |
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