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The CoaguChek Pro APTT test is for the quantitative determination of the activated partical thromboplastin time (APTT) of freshly drawn whole blood. It is intended for health care professional use only.

The APTT is used to evaluate intrinsic pathway function. The APTT is sensitive to deficiencies of factors VIII, IX, XI, and XII, prekallikrein, high molecular weight kinogen, as well as common pathway factors (II, V, X, and fibrinogen). The APTT is useful as a screening test for coagulation function, since it is sensitive to all coagulation factors except VII, platelet factor III and calcium. Additionally, the APTT is used to monitor the effectiveness of heparin therapy. Many diseases and drugs can prolong or prevent coagulation by altering the balance of clotting factors involved in coagulation. The APTT test is initiated by inserting a CoaguChek Pro APTT test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the APTT. The displayed result is equivalent to laboratory plasma APTT results. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.

The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® test principle is based on the competitive principle. Total duration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions.

The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (ph 1 - 2). Bilirubin + diazonium ion acid -> Azobilirubin The intensity of the color of the azobilirubin formed is proportional to the total bilirubin concentration and can be measured photometrically.