Roche CoaguChek XS System Bedienungsanleitung PDF herunterladen

Cat. No. 04625315160

48 Test Strips, 1 Code Chip

0 4625706001(01)

V1/R1 (black) – 2006-09

CoaguChek

XS PT Test

This is a CLIA waived system. These test strips are to be used with the CoaguChek XS

System. A certicate of CLIA waiver is required to perform the test in a waived setting.

For more information on how to obtain a certicate, visit www.cms.hhs.gov/clia.

Purpose

The CoaguChek XS System is intended for use by professional healthcare provid-

ers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole

blood.

Caution: These test strips are for use outside the body only. Do not eat the test

strips.

Before You Start Testing

If you are new to the CoaguChek XS System, watch the CoaguChek XS System Video

and read the CoaguChek XS System Getting Started guide before testing.

Storing the Test Strips

Store the test strips in their container, with the cap closed. You can store the test

strips at room temperature or in the refrigerator (2 to 30°C or 36 to 86°F). When stored

properly, the test strips can be used up until the expiration date printed on the test

strip container.

Dispose of the test strips if they are past their “Use By” date.

Handling the Test Strips

When you are ready to test, remove 1 test strip from the container. Do not open a vial

of test strips or touch a test strip with wet hands or gloves. This may damage the test

strips. Close the container tightly.

You must use the test strip within 10 minutes of removing it from the container. Other-

wise, 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 ngerstick. Optionally,

you may use a capillary tube to collect the ngerstick blood sample. You may also use

the CoaguChek XS System to test venous blood. See Optional Testing Methods in the

CoaguChek XS System User Manual for more information. When collecting any type of

sample, follow universal blood collection precautions and guidelines.

Step 1: Getting Ready to Test

Gather supplies:

• CoaguChek XS Meter

• CoaguChek XS PT Test Strip

• Test Strip Code Chip

• Lancet (Follow the manufacturer’s instructions to prepare the lancet for use.)

If you are using test strips from a new, unopened box, you will need to change the

Test Strip Code Chip. The 3-number code on the test strip container must match the

3-number code on the code chip. To install the code chip, follow the instructions in

the Code Chip section of the CoaguChek XS System User Manual.

Put the meter on a at surface, like a table or countertop, that will not vibrate or move

during testing, as this can result in an error message.

Step 2: Testing Blood from a Fingerstick

Getting a Good Drop of Blood

Increasing the blood ow in the nger will help you get a good drop of blood. Before

you lance the nger, try the following techniques until you see that the ngertip has

good color:

• Warm the hand by having the patient hold it under his or her armpit, use a hand

warmer, and/or wash the hand with warm water.

• Have the patient hold his or her arm down to the side, so that the hand is below

the waist.

• Massage the nger from its base.

• If needed, immediately after lancing, gently squeeze the nger from its base to

encourage blood ow.

Procedure

1. Wash the patient’s hands with warm, soapy water or wipe the nger with alcohol.

Allow the patient’s nger to dry completely before performing the ngerstick.

2. Take a test strip out of the container. Close the container tightly.

3. Insert a test strip as far as you can. The meter turns on.

4. Conrm that the number displayed matches the number on the test strip con-

tainer, then press M. If the numbers are different, make sure you are using the

code chip that came with the test strips you are using.

5. An hourglass appears as the meter warms up, which takes about 30 seconds.

6. When the meter is warmed up, a ashing test strip and blood drop symbol appear

and the meter begins a countdown. You have 120 seconds to apply blood to the

test strip.

7. Use the lancet to perform a ngerstick.

8. Apply 1 drop of blood to the top or side of the target area. You must apply blood

to the test strip within 15 seconds of lancing the nger.

9. Do not add more blood. Do not touch or remove the test strip when a test is in

progress.

10. The result appears in about 1 minute. Record the result.

11. Properly dispose of the used lancet and test strip.

12. Turn the meter off.

If you need to redo a test, use a new lancet, a new test strip, and a different nger.

Technical Information

How the Test Works

The CoaguChek XS PT Test, used as directed with the CoaguChek XS Meter, will

provide an electrochemical measurement of prothrombin time following activation of

blood coagulation with human recombinant thromboplastin. In simple terms, blood

works with the chemicals in the test strip to make a small electric current in the test

strip that measures blood-clotting time.

Contents of the Test Strip

The test strip contains reagent (human recombinant thromboplastin 1.5 U), as well as

stabilizers, preservatives, and additives.

Limitations of Procedure

• The CoaguChek XS PT Test uses only fresh capillary or non-anticoagulated venous

whole blood. Plasma or serum cannot be used.

• Use only plastic syringes without anticoagulants or additives. Glass tubes or sy-

ringes must not be used.

• The blood drop must be a minimum of 10 µL in volume. Low sample volume will

cause an error message.

• Never add more blood to test strip after test has begun or perform another test

using the same ngerstick.

• When a patient is on intravenous infusion therapy, do not collect sample from arm

receiving the infusion line.

• Hematocrit ranges between 25-55% do not signicantly affect test results.

• Testing performed with the following in vitro spiked samples or native blood

samples (Triglycerides) indicated no signicant effect on test results:

• Bilirubin up to 30 mg/dL

• Lipemic samples containing up to 500 mg/dL of triglycerides

• Hemolysis up to 1000 mg/dL

• The results are unaffected by heparin concentrations up to 0.8 U/mL.

• The CoaguChek XS PT Test is insensitive to low molecular weight heparins

(LMWH) up to 2 IU anti-factor Xa activity/mL.

• The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies

(LA) can potentially lead to prolonged clotting times, i.e., elevated INR values. A

comparison to an APA-insensitive laboratory method is recommended if the pres-

ence of APAs is known or suspected.

• In rare cases, patients with long clotting times (>8 INR) may receive an “ERROR 7”

message on the meter display. If this error message appears again when the test is

repeated, the result must be checked using another method.

Expected Results

The CoaguChek XS Meter displays test results in units equivalent to laboratory

plasma measurements. Results may be displayed in the International Normalized

Ratio (INR=(PT/Mean Normal PT)

ISI

), seconds, and % Quick (a unit used mainly by

healthcare professionals in Europe).

Each lot of test strips is calibrated to a reference lot that is traceable to the WHO

International Reference Preparations. Normal INR levels vary from person to person.

When the CoaguChek XS PT Test was performed using the CoaguChek XS Meter on

121 normal, healthy, warfarin-free individuals using venous and capillary samples,

97% of the INRs ranged from 0.9 to 1.1. For the purpose of providing universal INR

results, the Mean Normal Prothrombin Time (MNPT) has been established as 12 sec-

onds for healthy volunteers and the International Sensitivity Index (ISI) for the system

has been established as 1.

The physician must determine the best INR level depending on the reason for

anticoagulant treatment and how each individual responds to treatment (based on

Prothrombin Time). Each physician should establish expected values for his or her

patient population or individual patients.

Differences in reagents, instruments, and pre-analytical variables can affect pro-

thrombin time results. These factors should be considered when comparing different

prothrombin time test methods.

Unusual Results

If the meter displays an error message, refer to the Error Messages section of the

CoaguChek XS System User Manual. If the meter displays an unusual test result (other

than an error message), check the following items:

Accuracy: 710 venous samples were collected from 355 outpatients at three external

sites. The INR of each sample was compared to the INR of a venous plasma sample

measured on a Sysmex Analyzer using Dade Innovin (ISI = 1.02). The patient clinical

conditions included (number of patients): normal - not on warfarin (62), atrial bril-

lation (174), valve replacement (35), stroke/TIA (28), DVT (16), other heart-related

disorders (4), other clotting disorders (6), other (30).

Venous Data:

N Slope Intercept Correlation

Site 1 232 1.129 -0.10 0.983

Site 2 230 1.111 -0.11 0.971

Site 3 248 0.984 -0.03 0.986

All 710 1.034 -0.02 0.974

• Is the correct code chip in the meter? The 3-number code on the test strip con-

tainer must match the 3-number code on the code chip.

• Is the meter set up with the correct date and time?

Certain drugs may affect results by affecting warfarin pharmacology. The potential ef-

fect of a drug interaction with warfarin or the effect of underlying diseases (e.g., liver

disease, congestive heart failure) must be considered when interpreting a result.

Also, changes in the patient’s diet can cause unusually low or high results.

Any unusual result should always be followed up with appropriate coagulation stud-

ies and inquiries to dene the cause of the unusual result.

If the result does not match the clinical symptoms, repeat the patient test to rule out

procedural error.

Performance Characteristics

Measuring Range: The CoaguChek XS System has a reportable range of 0.8 to 8.0

INR.

Sensitivity: The CoaguChek XS PT Test is sensitive to various clotting factors as de-

termined by in vitro tests. Single factor depleted plasma was combined with a normal

plasma pool to produce a series of diluted plasma samples. These plasma samples

were then tested using three representative lots of the CoaguChek XS PT Test across

sixteen CoaguChek XS meters. The results, as seen in the graph below, represent the

typical CoaguChek XS PT Test sensitivity to Factors II, V, VII, and X.

CoaguChek XS Factor Sensitivity

INR

3.0

2.5

2.0

1.5

1.0

0.5

0.0

100 75 50 25 12.5 6.25

Factor II Factor V Factor VII Factor X ....... Normal Range

.......

% Factor

Venous Data from All Sites

710 Samples from 355 Patients

Dade Innovin INR

CoaguChek XS INR

0 1 2 3 4 5 6 7 8 9

y = 1.034x - 0.02

Slp Cl (1.017, 1.053)

Int Cl (-0.04, 0.01)

Correlation = 0.974

1 2

Inhaltsverzeichnis

Seite 1 - XS PT Test

Cat. No. 0462531516048 Test Strips, 1 Code Chip0 4625706001(01)V1/R1 (black) – 2006-09CoaguChek® XS PT TestUSThis is a CLIA waived system. These test

Seite 2 - Limited Warranty

0 4625706001(01)R1 (black)The following U.S. patents have been granted or are pending for the CoaguChek XS System (meter and test strips): 6,662,439;

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