++++ Change of ¼ ++++ Please read marked text carefully!

++++
Hemostat Thromboplastin-SI If the Application Sheets are not accessible via internet, they can be
obtained free of charge from your local distributor. The Application Sheets
Determination of Prothrombin Time (PT) contain analyzer/assay specific handling and performance information.
Please also consult the user manual of the respective instrument.
Package Size
[REF] 31002 6 x 2 ml Manual Testing on HumaClot Junior and HumaClot DuoPlus
31003 6 x 10 ml Perform duplicate testing of samples and controls.
[IVD] HumaClot Junior
HumaClot DuoPlus
Intended Use
Pre-warm [RGT] to 37°C before use (stir during use) and pre-warm test
HEMOSTAT THROMBOPLASTIN-SI (PT-SI) is a highly sensitive reagent
tubes.
intended for the manual and automated determination of prothrombin
time (PT). Prolongation of the PT indicates either acquired or congenital Pipette Plasma/ Control into pre-warmed test 100 μl
disorders that affect coagulation factors I, II, V, VII and X. The PT has been tube.
widely accepted as the means to monitor patients on oral anticoagulant Incubate 3 min. at 37°C.
therapy, due to the reduction in the activity of vitamin K dependent Add pre-warmed [RGT] 200 μl
clotting factors (II, VII, IX, X, Protein C and S). HEMOSTAT
THROMBOPLASTIN-SI can be used to assay coagulation factors in the Start timer with addition of [RGT]. Record time required for clot
extrinsic and common pathways of coagulation. formation.

Test Principle Quality Control

The one-stage PT measures the clotting time of plasma after adding a Routine quality control is indispensable in coagulation testing.
source of tissue factor (thromboplastin) and calcium. The recalcification of HEMOSTAT CONTROL PLASMA NORMAL (CPN) and HEMOSTAT CONTROL
plasma in the presence of tissue factor generates activated factor Xa, with PLASMA ABNORMAL (CPA) should be run in conjunction with patient
the consequent formation of thrombin and ultimately an insoluble fibrin plasmas. CPN is a normal plasma, whereas CPA is adjusted to mimic
clot. moderately deficient plasmas.
Contents Results: The results can be reported in seconds, in Prothrombin ratio, in %
[REF] [RGT] [BUF] of norm or as INR.
31002 6 x 2 ml 6 x 2 ml Seconds: Calculate the mean time of duplicate PT determination for each
plasma and report to the nearest 0.1 second.
31003 6 x 10 ml 6 x 10 ml
Prothrombin Ratio (PR): To obtain the Prothrombin ratio, the reaction
[RGT] Thromboplastin reagent (lyophilised)
time of the sample is divided by the reaction time of the normal plasma
Rabbit brain extract >10%
pool.
Sodium azide <0.01%
PTpatient [s]
[BUF] CaCl2
PR = 
Sodium azide <0.01%
PTnormal plasma pool [s]
Material required but not provided HEMOSTAT CALIBRATOR can be used as a normal plasma pool (please
[REF] 35500 HEMOSTAT CALIBRATOR refer to the table “Examples of Reconstitution” in the HEMOSTAT
[REF] 35001 HEMOSTAT CONTROL PLASMA NORMAL CALIBRATOR instruction for use (IFU)). Alternatively, a normal plasma pool
of apparently “healthy” donors can be prepared.8
[REF] 35002 HEMOSTAT CONTROL PLASMA ABNORMAL
% of norm: To report results in % of norm a calibration curve is required.
Sodium chloride 0.9 % (0.154 mol/l) Prepare a calibration curve using HEMOSTAT CALIBRATOR. Alternatively
Reagent Preparation the calibration curve can be generated with a normal plasma pool
Reconstitute 1 vial of [RGT] with the entire content of 1 vial of [BUF] of the prepared from apparently “healthy” donors, declaring the Prothrombin
same lot. Keep [RGT] warm at 37°C for at least 30 minutes for proper time as 100%.
reconstitution. Swirl the vial gently, horizontally more times (5-10) before Establishment of the Reference Curve - Fully Automated Testing
use, but do not shake. Refer to the HEMOSTAT CALIBRATOR IFU and the user manual or the
Note Application Sheets of the instrument.
In case of doubt, using a pipette to transfer the buffer into the reagent vial Establishment of the Reference Curve – Manual Testing
for reconstitution will provide better control over the transferred volume. Generate a calibration curve diluting the HEMOSTAT CALIBRATOR (for
Storage and Stability correct reconstitution please refer to the table “Examples for
When stored at 2...8°C unopened vials are stable until the expiry date. Reconstitution” in the HEMOSTAT CALIBRATOR IFU) or a normal plasma
pool with sodium chloride (0,154 mol/l):
Stability of [RGT] after reconstitution
Dilution Scheme
Temperature 37°C 20…25°C 15…19°C 2…8°C
HEMOSTAT undiluted 1+1 1+3 1+7
Time 8 hours 1 day 5 days 12 days
CALIBRATOR or normal
Store at 2...8°C when not in use. Do not freeze reconstituted [RGT]. plasma pool
Specimen Collection % of norm 100% 50% 25% 12.5%
Use 3.2% sodium citrate as anticoagulant. The use of higher concentration INR: The interdependency of the Prothrombin time of the used
of trisodium citrate (3.8 %; 129 mmol/l) is not recommended. Obtain Thromboplastin and instrument can be corrected through the
venous blood by clean venipuncture. Immediately mix 9 parts of blood determination of the “International Normalized Ratio (INR). For this
with 1 part of anticoagulant. Avoid foaming the specimen. purpose the Prothrombin ratio can be converted into internationally
Specimen Processing comparable values by means of the “International Sensitivity Index (ISI)”.
Centrifuge the blood specimen for 15 minutes at 1500 x g to yield platelet INR = PRISI
poor or platelet free plasma. Remove plasma using a plastic pipette and The ISI-value for HEMOSTAT THROMBOPLASTIN-SI is stated in the lot-
store in a plastic tube. Cover specimens to prevent pH changes that may specific Table of Assigned Values.
affect test results.
Reference Range
Specimens maintained at 18...25°C must be tested within 24 hours. Do
For normal plasma a range of PT = 10-14 seconds can be expected.
not store plasma at 2...8°C, because it may undergo cold activation
resulting in significant shortening of the PT. For longer periods of time, Each laboratory should establish its own normal range using instrumen-
plasma should be frozen at -20°C for up to 2 weeks or at -70°C for up to 12 tation, blood collection methods, and testing techniques commonly used
months. Thaw samples rapidly at 37°C, swirl gently and test immediately. in that laboratory. The normal range should be re-established with any
Do not re-freeze. change in instrumentation, blood collection techniques, anticoagulant
and should be at least verified when changing to new lots of reagents.
Test Procedure
HEMOSTAT THROMBOPLASTIN-SI can be used manually or on automated Limitations
coagulation analyzers. The PT may be prolonged by substances including corticosteroids, EDTA,
oral contraceptives, asparaginase, clofibrate, erythromycin, ethanol,
Fully Automated Testing and Manual Testing on HumaClot Junior model tetracycline and anticoagulants, such as heparin and warfarin.
HC1, HumaClot Duo model HC2 and HumaClot Quattro
The Application Sheets can be accessed via www.human.de/aps-coag/
The PT may be shortened by substances including antihistamines,
butabarbital, caffeine, oral contraceptives, phenobarbital and vitamin K.
Performance Characteristics
Typical performance data can be found in the Verification Report at
www.human.de/data/gb/vr/co-ptsi.pdf or
www.human-de.com/data/gb/vr/co-ptsi.pdf
If the performance data are not accessible via internet, they can be
obtained free of charge from your local distributor.
Safety Notes
[RGT] [BUF]
P260 Do not breathe dust/fume/gas/mist/vapours/spray.
P262 Do not get in eyes, on skin, or on clothing.
P281 Use personal protective equipment as required.
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all
contaminated clothing. Rinse skin with water/shower.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if present and easy to do. Continue
rinsing.
P337+P313 If eye irritation persists: Get medical advice/attention.
P401 Store in accordance with local/regional/national/international
regulations.
P501 Dispose of contents/container in accordance with local/regional/
national/international regulations.

CO-PTSI INF 3100201 GB 01-2020-015 |

Human Gesellschaft für Biochemica und Diagnostica mbH

Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
Telefon +49 6122-9988-0 · Telefax +49 6122-9988-100 · e-Mail human@human.de