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Clinical Laboratory - Disease Topic Overview

Clinical laboratories are usually located within hospitals and are responsible for processing biochemical tests.

A lot can be discovered about the health of a patient by testing the components of their bodily fluids (blood, urine and faeces). The clinical laboratory is responsible for performing these tests in an accurate manner. The areas of testing include; haematology, microbiology, chemistry and immunology.¹

Microbiological tests are used to show the presence of bacteria, fungi, viruses and parasites in the human body.² This knowledge allows physicians to administer a more specific treatment with higher efficacy. This is of particular importance in a hospital setting where infection has occurred as complication following admission.

Biochemical tests are regularly used in medicine, both as a method for diagnosing and monitoring known metabolic disorders such as diabetes and hyperthyroidism, and to detect changes that could be the result of an underlying disease.³ Chemical tests to determine these include; acid-base tests to determine respiratory complications, fluid balance and electrolytes tests, renal function tests to determine the functioning of the glomeruli and tubules, presence of tumour markers, liver function tests and markers that determine myocardial injury.³ Most chemical tests are used to confirm a diagnosis and enable effective treatment plans to be implemented.

Immunodiagnostic and serodiagnostic tests measure the presence of antibodies in circulating blood and have been a gold-standard in detecting infection for years.⁴ In addition to disease detection, these tests are also able to detect Human Leucocyte Antigens (HLA) and determine a patient's Major Histocompatibility Complex (MHC). This is of particular importance in patients who are scheduled for organ transplant.⁴ This test determines whether a donor and recipient are compatible and therefore whether the organ is likely to be tolerated by the recipient's immune system.

1. Jones S.L. Clinical Laboratory Pearls. Lippincott, Williams and Wilkins. 2000 : 634 pages.
2. Nagoba B.S. et al. Clinical Microbiology. BI Publications Pvt Ltd. 2009 : 8-44.
3. Marshall W.J. et al. Clinical Chemistry. Elsevier Health Sciences. 2008 : 416 pages.
4. Fischback F.T. et al. A Manual of Laboratory and Diagnostic Tests. Lippincott, Williams and Wilkins. 2009 : 564-688.

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Latest Journal Publications

Archives of Gerontology and Geriatrics

Pneumonia is the second most common infection in long term care (LTC) residents and is a leading cause of death from infection in those groups of patients. Atypical presentations and fewer presenting signs and symptoms in older patients complicate diagnosis and delay initiation of adequate treatment. The aim of this study was to compare laboratory CRP levels to pneumonia severity scores, in prediction of short-term death from pneumonia. Diagnosis of pneumonia was performed according to the criteria of McGeer for the identification of pneumonia at an LTC facility. The severities of pneumonia and mortality prediction were assessed by three indices: PSI (pneumonia severity index), Missouri study index and the nursing home associated pneumonia (NHAP) severity index. A strong positive correlation was found between CRP levels and PSI (r=0.445, p<0.001), Missouri study index (r=0.315, p<0.001) and NHAP severity index (r=0.246, p=0.002). The initial values of CRP were significantly higher in patients with short term mortality and positively correlated with rate of death (r=0.493, p<0.001). By multivariate regression analysis, the variables that were independently and significantly associated with the rate of death included presence and duration of fever, respiratory rate, serum CRP and albumin levels, lymphocyte count, number of comorbid diseases, CHF, and DM (the R2 was 0.711 and 0.685 when adjusted). Because presentation of nursing home acquired pneumonia is not specific, it is suggested that CRP should be performed in every patient with a suspicion of pneumonia.

Journal of Medical Virology

In Southernmost Brazil HIV-1 subtypes B, C, and CRF31_BC co-circulates and, since 1996 with the implementation of free access to highly active antiretroviral treatment (HAART), this epidemic is under a quite characteristic selective pressure. The profile of mutations and polymorphisms in the protease (PR) and reverse transcriptase (RT) genes of HIV-1 from untreated patients living in Porto Alegre, Southernmost Brazil were evaluated in order to identify the subtypes and circulating drug resistant genotypes. Blood samples from 99 HIV-1 positive drugs-naïve patients were collected from 2006 to 2007 in Porto Alegre, Brazil. HIV PR and RT genes were amplified, sequenced, and subtyped. The HIV-1 genotyping was performed by partial sequence analysis of the pol in the HIV Drug Resistance Database of Stanford University. Phylogenetic analyses allowed to classify the HIV samples according to their subtypes: B (26.2%), C (39.4%), F (1.1%), CRF31_CB (19.2%), and URF (14.1%). Eight (8.1%) samples showed primary resistance mutations according to the Calibrated Population Resistance tool based in the 2009 Surveillance Drug Resistance Mutation list. Two samples presented resistance mutations to PI, three NRTI and three NNRTI. There was no significant association between presence of resistant genotypes and subtypes, but resistance mutations seem to be less frequent in the subtype C. In addition, this study describes for the first time the mutational profile of CRF31_BC to PI, NRTI, and NNRTI. Genetic analyses of HIV-1 from naïve patients are a promising and important method for surveillance of HIV infection.

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23^rd February 2012

NX 1207 (Recordati/Nymox) starts Phase III trial for BPH Men's Health, Andrology and Urology Page

Recordati and Nymox Pharmaceutical Corporation announced the start of activities aimed to the preparation of a European Phase III clinical trial for NX-1207, following the successful completion of a Scientific Advice meeting with the European Medicines Agency. NX-1207, is a Phase III investigational drug from Nymox and is currently in clinical development in the United States for the treatment of Benign Prostatic Hyperplasia (BPH). The pivotal controlled clinical trial will assess the efficacy and safety of a single TRUS-guided intraprostatic injection of NX-1207 in patients with lower urinary tract symptoms (LUTS) associated with BPH not adequately controlled by medical therapy.The drug is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs and involves little or no pain or discomfort. NX-1207 has successfully completed a series of blinded controlled multi-center U.S. clinical trials where a single dose of NX-1207 has been found to improve the signs and symptoms of BPH, with improvements about double those reported for currently approved BPH drugs, and without the side effects associated with those drugs, which can include sexual problems and blood pressure changes. Follow-up studies have shown evidence of long lasting benefit with a significant proportion of men reporting maintained improvement in BPH symptoms without other treatments for up to 7½ years.

Zelboraf (Daiichi Sankyo/Roche) is EU approved for BRAFV600 mutation Metastatic Melanoma Page

Plexxikon Inc., a member of Daiichi Sankyo Group,has announced that the European Commission has approved Zelboraf (vemurafenib) for the monotherapy treatment of adult patients with BRAFV600 mutation-positive unresectable or Metastatic Melanoma. The cobas 4800 BRAF V600 Mutation Test, a companion diagnostic used to identify patients with the BRAF mutation, is CE marked and commercially available in Europe. Zelboraf is designed to selectively inhibit the BRAF mutation that occurs in about half of all cases of melanoma. Zelboraf and its companion diagnostic have already been approved in the United States, Switzerland, Israel, Brazil, New Zealand and Canada. In the United States, Zelboraf is being co-promoted by Daiichi Sankyo, Inc. and Genentech, a member of the Roche Group. Roche promotes Zelboraf outside of the United States.

CHMP recommends Pixuvri (CTI Life Sciences) for Non Hodgkin's B-cell Lymphoma Oncology Page

The CHMP has given a conditional recommendation for the approval of Pixuvri (pixantrone dimaleate) from CTI Life Sciences for relapsed or refractory aggressive non-Hodgkin’s B-cell Lymphoma. The drug application at the FDA was withdrawn as additional information was requested. The drug is now scheduled to be considered at the FDA Advisory Comitteee meeting in April 2012.