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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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| 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/ TaqMan® HIV-1 real-time PCR platform. The reagents have been developed to ensure equivalent quantitation of group M subtypes of HIV-1. This test targets the highly conserved region of the HIV-1 gag gene. The reportable quantitative range of the assay is FDA approved at 48 to 10,000,000 copies/ml. |
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| Effective February 2009, NorDx will begin HCV RNA viral load testing on plasma or serum using the Roche COBAS AmpliPrep/ TaqMan® HCV real-time PCR platform. The reagents have been developed for the quantitation of the six HCV genotypes. This test targets the highly conserved 5' untranslated region of the HCV. The reportable quantitative range of the assay is FDA approved at 43 to 69,000,000 IU/ml. The limit of detection (LOD) is 18 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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| An in vitro diagnostic test used to differentiate among several common leukemias including: acute myeloid leukemia (AML), pre-B-cell acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL), and acute promyelocytic leukemia (APL). |
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| Clients may order HPV genotyping on patients that have tested positive for the HPV high risk screen (HPVHR, HPVH, or HPVHO). |
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| Human papilloma viruses are a group of more than 100 different viruses. Several high risk types of HPV have been associated with a variety of cancers including cervical, oral, anal, and penile cancers. This assay detects only these high risk HPV types. Low risk types of HPV associated with benign genital warts are not detected by this assay |
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