COAGUCHEK XS PT Test, 24 hours

Area of application

With CoaguChek XS PT test you can determine your prothrombin time.This is particularly useful if you have blood clotting disorders or are taking anticoagulant medications.The test is suitable for self-administration and is also known as a quick test or under the abbreviation PT.

Mode of action

The CoaguChek XS PT test consists of 24 test strips suitable for the in vitro quantitative determination of prothrombin time of capillary whole blood or non-anticoagulated venous whole blood using a CoaguChek XS/XS Plus/XS Pro device.The test principle is based on an electrochemical measurement of the prothrombin time after activation of blood coagulation with recombinant human thromboplastin.Each test strip contains a test field with a prothrombin reagent.Once the blood is applied, the reagent is dissolved and an electrochemical reaction occurs, which is converted into a clotting time value.This value is shown on the device display in INR-units.

The test strips contain a reagent in dried form, the reactive components of which consist of thromboplastin, a recombinant human tissue factor (hrTF), and a peptide substrate.When the blood sample is applied, the thromboplastin activates the coagulation cascade, resulting in the formation of thrombin.At the same time, the measuring device begins measuring time.The enzyme thrombin cleaves the peptide substrate, which generates an electrochemical signal.Depending on the time of its occurrence, this signal is converted into the coagulation units INR, % Quick and seconds by a corresponding algorithm and shown on the display after 60 seconds.

Measuring range and therapeutic range

The measurement results on the CoaguChek XS/XS Plus/XS Pro device can be displayed in the following units: INR (International Normalized Ratio), % Quick and seconds.The measuring ranges are as follows: 0.8-8.0 INR (5-120% Quick).Your individual therapeutic range will be determined by your treating doctor.The association between INR and % Quick may vary slightly depending on the test strip lot of CoaguChek XS PT Test.

Procedure for measurement results outside the therapeutic range

If the measurement results are unusually low or high, the test must be repeated.If the measurement result is still outside the therapeutic range specified by the doctor, the treating doctor must be notified immediately and an agreement must be made regarding further (anticoagulation) measures in order to prevent a risk from too strong anticoagulation (risk of bleeding) or too little anticoagulation (risk of thrombosis).

Notes on PTself-determination

If PTself-determination is carried out by the patient in addition to treatment by the doctor, the following must be noted: PTself-determination supports medical control, but cannot replace it.The PTself-determination gives the anticoagulated patient more security in everyday life.The measurement results obtained should be entered in a diary (patient pass) and presented to the doctor regularly.This makes it easier for the doctor to assess the quality of the therapy setting.

Sample material

Use only fresh capillary blood or venous whole blood without anticoagulants (heparin, EDTA, citrate, oxalate or other substances).If you use capillaries, please only use the special CoaguChek capillary tubes.

Storage and shelf life

The test strips should be stored at 2-30°C.If stored at room temperature or in a refrigerator, the test strips can be kept until the expiry date stated on the package or test strip container.Do not use test strips beyond the stated expiry date.Close the tube tightly again immediately after removing a test strip.This is necessary so that the remaining test strips do not become unusable due to external influences such as humidity.

Materials supplied

- Test strips and 1 code chip

Additional materials required

- CoaguChek XS Plus device or CoaguChek XS Pro device or CoaguChek XS device
- CoaguChek XS PT Controls
- Lancing device, e.g. CoaguChek XS Softclix
- Lancets (CoaguChek Softclix Lancet or Accu-Chek Safe-T-Pro Plus)

The CoaguChek XS Softclix lancing device was specially developed for self-control by the patient.It is not suitable for use in the clinic or for testing different people due to the risk of infection. Healthcare professionals performing testing on multiple patients must be aware that there is a potential risk of infection.Any object that comes into contact with human blood represents a potential source of infection.

Dosage

Recommended use of CoaguChek XS PT Test: You can carry out a measurement with CoaguChek XS PT Test if necessary.Just a drop of blood from the fingertip is enough.Please also note the application instructions in the enclosed package leaflet.

Notes

No prescription is required for this product.

Manufacturer

Roche Diagnostics Deutschland GmbH, Sandhofer Straße 116, 68305 Mannheim