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

++++
For Antithrombin testing, please read the HEMOSTAT ANTITHROMBINliquid
Hemostat Calibrator ([REF] 36102) instruction for use carefully.

Calibrator Plasma Limitations

The distilled water for reconstitution of the reagent must be free from
Package Size preservatives and free from bacterial or other contamination. Inadequate
[REF] 35500 4 × 1.0 ml Calibrator Kit quality of water may lead to unreliable results and reduced stability.
[IVD] Performance Characteristics
Intended Use Typical performance data can be found in the Verification Report,
HEMOSTAT CALIBRATOR is intended for the calibration of tests to assay accessible via
Prothrombin time (PT) and Antithrombin. www.human.de/data/gb/vr/co-cal.pdf or
Content www.human-de.com/data/gb/vr/co-cal.pdf
[CAL] 4 x 1 ml Calibrator (blue cap, lyophilized) If the performance data are not accessible via internet, they can be
Pooled human plasma obtained free of charge from your local distributor.
Sodium azide < 0.01%
Notes
The lot-specific analytical value of [CAL] for HEMOSTAT
The handling should always follow common good laboratory practice
THROMBOPLASTIN-SI, HEMOSTAT THROMBOPLASTINliquid and HEMOSTAT
requirements (*)! The validation criteria must be met!
ANTITHROMBINliquid is stated on the enclosed Analytical Value Sheet in
the kit. (*This includes: Proper caps being replaced on the vials and firmly tightened / Remove only
reagents required for a run from stock solutions if they could come into contact with other
Materials required but not provided contaminating solutions like patient specimens etc. / Stock solutions always have to be
- Distilled or deionized water without preservatives for reconstitution of returned to 2-8°C when not in use.
[CAL]
Microbial contamination of HEMOSTAT CALIBRATOR should be avoided,
- Sodium chloride 0.9 % (0.154 mol/l) (as [DIL]) for dilution of because it can lead to incorrect results.
reconstituted [CAL].
Safety Notes
Storage and Stability P234 Keep only in original container.
The components of HEMOSTAT CALIBRATOR are stable until the expiry P260 Do not breathe dust/fume/gas/mist/vapours/spray.
dates stated on the vial labels when stored at 2-8°C. After reconstitution,
P262 Do not get in eyes, on skin, or on clothing.
[CAL] is stable for 6 hours when stored at 20-25°C, in the original vial.
P281 Use personal protective equipment as required.
The reference curve is valid for the respective lot of the reagent employed
and has to be renewed after each change of lot. P303+P361+P353 IF ON SKIN (or hair): Take off immediately all
contaminated clothing. Rinse skin with water/shower.
Preparation and Test Procedure P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
HEMOSTAT CALIBRATOR can be used manually or on automated minutes. Remove contact lenses, if present and easy to do. Continue
coagulation analyzers. rinsing.
To establish a [CAL] reference curve with HEMOSTAT THROMBOPLASTIN- P337+P313 If eye irritation persists: Get medical advice/attention.
SI, HEMOSTAT THROMBOPLASTINliquid and HEMOSTAT ANTITHROMBINliquid P401 Store in accordance with local/regional/national/international
it is necessary to dilute [CAL] with 0.9% sodium chloride. regulations.
Fully Automated Testing and Manual Testing (PT) with HumaClot Junior P501 Dispose of contents/container in accordance with local/ regional/
national/international regulations.
(model HC1), Duo PLUS (model HC2) and Quattro (model HC4)
Reconstitute the contents of each [CAL] with 1 ml of distilled water (see All sera used for the manufacture of the calibrator have been checked on
Limitations/Notes). Keep it at room temperature (20-25°C) for 30 minutes. donor level for HCV and HIV-1/2 antibodies and HBsAg and found
Swirl the vial gently before use and do not shake. Avoid the contact of negative.
fluid with the stopper. For users in the European Union only: Please report any serious incident
The Application Sheets for HumaClot Pro, HumaClot Junior (model HC1), that has occurred in relation to the device to the manufacturer and the
Duo PLUS (model HC2), or Quattro (model HC4) can be obtained through competent authority of the Member State in which the user and/or the
your local distributor. The Application Sheets contain analyzer/assay patient is established.
specific handling and performance information which may differ from References
that provided in these Instructions for Use. Please also consult the WHO Expert Committee on Standardisation: WHO Technical Report
instruction manual of the instrument. Series. No. 889 (1999)
Manual Testing (PT) with HumaClot Junior and HumaClot Duo PLUS
Reconstitute the contents of each [CAL] with distilled or deionized water
(see Limitations/Notes) according to the below table “Examples for
reconstitution”. Keep it at room temperature (20-25°C) for 30 minutes.
CO-CAL INF 3550001 GB 03-2021-005 |
Swirl the vial gently before use and do not shake. Avoid the contact of
fluid with the stopper.
Examples for reconstitution for PT:
Examples of analytical values of Required reconstitution volume
[CAL] as indicated in the (distilled or deionized water)
Analytical Value Sheet
100% 1000 µl
97% 970 µl
95% 950 µl
90% 900 µl
For the calibration curve with manual testing, like on HumaClot Junior or
HumaClot Duoplus the reconstituted [CAL] has to be diluted with 0.9 %
sodium chloride [DIL] according to the dilution scheme below.
Dilution scheme for PT:
HEMOSTAT undiluted 1+1 1+3 1+7
CALIBRATOR
reconst. [CAL] 100% 50% 25% 12.5%
[CAL] + [DIL] 1000µl [CAL] 250µl [CAL] 250µl [CAL] 250µl [CAL]
+ 0µl [DIL] 100% + 250µl 50% + 250µl 25% + 250µl
[DIL] [DIL] [DIL]

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