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Roche #04625315160 - Coaguchek XS Test Strips Vials 2x24/BX

Roche #04625315160 - Coaguchek XS Test Strips Vials 2x24/BX
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Product Description

Roche 04625315160 - Coaguchek XS Test Strips Vials 2x24/BX

CoaguChek XS PT Test

The CoaguChek XS Pro System is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy. The CoaguChek XS Pro System uses fresh capillary or non-anticoagulated venous whole blood. The term "System(s)" hereafter will refer to both the CoaguChek XS Pro System and the CoaguChek XS Plus System.

Before You Start Testing If you are new to the CoaguChek XS Pro System, watch the CoaguChek XS Pro System Training DVD and read the CoaguChek XS Pro System Getting Started Guide and CoaguChek XS Pro System User Manual. Read the CoaguChek XS Pro PT Controls package insert and this entire insert.

Storing the Test Strips Store the test strips in their original container, with the cap closed. You can store the test strips at room temperature or in the refrigerator (2-30 C or 36-86 F). When stored properly, the test strips can be used until the expiration date printed on the test strip container. Discard the test strips if they are past the expiration date on the container.

Handling the Test Strips When you are ready to test, open the test strip container and remove 1 test strip. Immediately close the container. Make sure it seals tightly. IMPORTANT: Do not open a container of test strips or touch a test strip with wet hands or wet gloves. This may damage the test strips. You must use the test strip within 10 minutes of removing it from the container. Otherwise, you may get an error message, and you will have to repeat the test.

Sample Collection and Preparation The steps that follow apply to collecting a blood sample from a fingerstick. Optionally, you may use a nonanticoagulated plastic capillary tube to collect the fingerstick blood sample. You may also use the CoaguChek XS Pro System to test venous blood. See the CoaguChek XS Pro System User Manual for more information. When collecting any type of sample, follow universal blood collection precautions and guidelines.

Technical Data

Accuracy: 811 venous samples were collected from 412 outpatients at three external sites. The INR of each sample was compared to the INR of a venous plasma sample measured on a Dade Sysmex 560 Analyzer using Dade Innovin (ISI = 1.02). The patient clinical conditions included (number of patients): not on warfarin (61), atrial fibrillation (163), valve repair/replacement (44), stroke/TIA (5), DVT (75), pulmonary embolism (22), cardiovascular accident (15), other heartrelated disorders (9), other clotting disorders (13), other (5). The results are as follows:

Venous Data:

Accuracy: 822 capillary samples were collected from 413 outpatients at three external sites. Capillary blood samples were assayed on the CoaguChek XS Plus Meter with the CoaguChek XS PT Test and venous samples were measured on a Dade Sysmex 560 Analyzer with Dade Innovin (ISI = 1.02). The results are as follows:

Precision: Whole blood precision was determined for venous and capillary blood from sample duplicates collected at three sites. The following results represent whole blood precision for venous and capillary blood.

Built-In Controls and Diagnostics The CoaguChek XS Pro System has quality control functions integrated into the meter and test strips, so you do not have to run quality control tests with liquid quality controls. A two-level, on-board quality control test is performed within the test chamber as part of every blood test. For more information about the built-in quality control functions, see the CoaguChek XS Pro System User Manual. Roche Diagnostics has available optional liquid quality controls 04625382160 for the CoaguChek XS Pro System. These controls are provided to assist with meeting regulatory compliance requirements, as applicable to your facility. Frequency and necessity of liquid quality control tests are at the discretion of each individual facility.