INSTRUCTION FOR USE

Dia-TT
THROMBIN TIME REAGENT

Cat. No.: 51036 12 x 3 ml

PREPARATION
PRODUCT NAME Dia-TT reagent is dissolved with the required
Dia-TT thrombin time reagent. amount of distilled water, which is indicated on
the label. Keep the reagent at room temperature
INTENDED USE
(20-25C) for at least 30 minutes for proper
(For In Vitro Diagnostic Use Only)
reconstitution. Swirl the vial gently, horizontally
Dia-TT is a freeze-dried reagent used for
more times (5-10) before using it, but do not
determination of Thrombin Time (TT).
shake. Wait until the reagent reaches the working
SUMMARY AND PRINCIPLE temperature!
The TT test is designed for the assessment of
SPECIMENS
fibrin formation. The TT is only affected by
Dia-TT test requires freshly decalcified plasma.
factors that interfere with thrombin or fibrinogen.
To obtain it, mix nine parts of freshly drawn
The TT is elevated in DIC (FDPs interfere with
venous blood with one part trisodium citrate
polymerisation), low fibrinogen levels,
(3,2%; 109mmol/L). The use of higher
dysfibrinogemia and heparin (very sensitive)
concentration of trisodium citrate (3,8%;
only.
129mmol/L) is not recommended. Mix the blood
PRINCIPLE carefully and centrifuge plasma before testing.
The Dia-TT test is performed by adding thrombin The measurement must be performed within 4
to plasma. The added thrombin directly clots hours. Do not store the sample at 2-8C. Refer to
fibrinogen of tested plasma. Clinical and Laboratory Standards Institute
(CLSI) guidelines H21-A5.
ACTIVE INGREDIENTS
Dia-TT is a freeze-dried, human thrombin in TEST PROCEDURE
buffered medium with calcium and preservative. Dia-TT test is a one-stage TT test, which can be
used with semi-automated coagulation analysers
PRECAUTIONS
(Coag 4D) according to the protocol detailed
 Person installing the Dia-TT reagent must be a
below. The duplicated measurement is
trained laboratory professional!
recommended.
 By calculating with inappropriate data or using
the supplied data improperly, erroneous results 1. Adding sample into cuvette 100l
may occur! 2. Sample incubation 2min
 Dia-TT reagent, due to its ingredients should be 3. Adding TT reagent into cuvette 100l
handled with care by observing the precautions
4. Simultaneously start the timer ~1min
recommended for biohazards material!
 Reagent coming into contact with specimens Normal control is recommended for verified
and other materials should be handled as if measuring. Each laboratory should establish its
capable of transmitting infection and should be own quality control program. In case of
disposed of with proper precautions! determination by any other coagulometer, please
 Avoid microbial contamination of the reagent follow the instructions of the manual.
otherwise erroneous results may occur!
 Each donor unit used in the preparation of this STORAGE AND STABILITY
reagent tested with HBsAg, anti-HIV 1-2, anti- Dia-TT reagent in intact vial is stable until the
HCV, anti-TP screening tests and found to be expiration date given on the vial, when stored at
non-reactive. 2-8C. Stability after opening in the original vial
 All reagents, waste and utilized disposable is shown in below table:
laboratory equipment should be considered as T (C) 20-25 15-19 2-8
hazardous waste! Their handling and disposal
Day 3 7 15
should be done according to the valid hazardous
material processing regulation.
 Do not use the reagent beyond the expiration
date printed on the label!

Date of issue: 15.09.2017. 1/2 Version: 5

 INSTRUCTION FOR USE
EXPECTED RESULTS DIAGON LTD.
Baross u. 48-52, 1047 Budapest, Hungary
Dia-TT test results can be reported in the
Tel.: +36 1 3696500
following units, lot specific sheet in the box will Fax.: +36 1 3696301
help in the calculation: Web: www.diagon.com
1. Seconds, which means the observed E-mail: diagon@diagon.com
clotting time.
2. Ratio (Ratio=TT/MNTT), which means SYMBOLS
the clotting time of the sample divided by the Manufacturer Use-by date
mean normal TT (MNTT). Method dependent
Batch code Catalogue number
MNTT value in the value sheet is only for
information, because it depends on the measuring Do not use if package Fragile, handle
circumstances and population. is damaged with care
Every laboratory should determine its own MNTT Keep dry Temperature limit
value and reference range. Our reference range is Consult instruction
Biological risks
the following on Diagon analysers (Coag Line): for use
In vitro diagnostic
Reference Mean Range from Range to Caution
medical device
Second 18,5 15,6 22,2 Contains sufficient
This side up
for <n> tests
LIMITATIONS CE mark
The result of TT test with Dia-TT reagent may be
influenced by drugs and other pre-analytical
interfering agents. The potential limits of these
parameters were tested on Diagon analysers
(Coag Line) with the following result:
Hemoglobin Triglicerid Bilirubin
3,4 g/L 4 mmol/L 240 μmol/L

PERFORMANCE CHARACTERISTICS
The reproducibility test of Dia-TT reagent on
automated coagulometer gives the following
results:
Intra-Assay Inter-Assay
Sample 1 1
n 10 10
Mean (sec) 26,8 26,0
CV (%) 2,006 2,882

MATERIALS REQUIRED BUT NOT

PROVIDED
 One level of control for quality control (Dia-
CONT I-II; Cat. No.: 91020, 91010).
 Optical or mechanical coagulation analyser for
measuring, Diagon analysers (Coag Line) are
recommended.
BIBLIOGRAPHY
1. CLSI: Collection, Transport, and Processing of Blood
Specimens for Testing Plasma-Based Coagulation Assays and
Molecular Hemostasis Assays; Approved Guideline- Fifth
Edition. CLSI document: H21-A5; 28:5; 2008.
2. Latallo ZS: Thrombin clotting assays. (Nils U. Bang
NU, Beller FK, Deutsch E, Mammen EF: Thrombosis and
Bleeding Disorders: Theory and Methods.) Academic Press,
New York; 183; 1971.

Date of issue: 15.09.2017. 2/2 Version: 5