HemosIL™

RecombiPlasTin 2G - 0020002950 (8 mL) / 0020003050 (20 mL) ENGLISH - Insert revision 09/2007
Intended use Additional reagents and control plasmas ACL Futura/ACL Advance Mean (PT seconds) CV % (Within run) CV % (Total)
A high sensitivity thromboplastin reagent based on recombinant human tissue factor The following are not supplied with the kits and may be purchased separately. Normal 12.5 1.1 1.9
(RTF) for the quantitative determination in human citrated plasma of Prothrombin Time Low Abnormal 23.8 1.6 1.9
(PT) on IL Coagulation and ELECTRATM Systems and Fibrinogen on IL Coagulation Americas and Pacific Rim Europe
Cat. No. Cat. No. High Abnormal 36.0 1.8 2.4
Systems only. The product is used for the evaluation of the extrinsic coagulation
pathway and the monitoring of Oral Anticoagulant Therapy (OAT). Calibration Plasma (IL Coagulation Systems) 0020003700 0020003700 ACL TOP Family Mean (PT seconds) CV % (Within run) CV % (Total)
Summary and principle Normal Control 0020003120 0020003110 Normal 11.9 0.8 2.2
Low Abnormal Control 0020003220 0020003210 Low Abnormal 22.0 0.8 3.1
The thromboplastin reagent included in the RecombiPlasTin 2G kit, after reconstitution High Abnormal Control 0020003320 0020003310 High Abnormal 34.0 0.9 3.1
with the RecombiPlasTin 2G Diluent, is a liposomal preparation that contains human Low Fibrinogen Control 0020004200 0020004200
RTF relipidated in a synthetic phospholipid blend and combined with calcium chloride, Factor Diluent (IL Coagulation Systems) 0009757600 0009757600 ACL Family Mean (Fibrinogen mg/dL) CV % (Within run) CV % (Total)
buffer and a preservative. The enhanced manufacturing process used for this reagent Owren’s Buffer (ELECTRA) 49738600 49738600 Normal 319 4.2 5.0
ensures an excellent lot to lot uniformity and better performance than thromboplastins Cleaning Solution 0009831700 0009831700 Low Fibrinogen Control 149 5.9 6.9
derived from natural sources.1 Due to its very high sensitivity, comparable to the Cleaning agent 0009832700 0009832700
International Reference Preparations, RecombiPlasTin 2G is especially suitable for ACL Futura/ACL Advance Mean (Fibrinogen mg/dL) CV % (Within run) CV % (Total)
monitoring Oral Anticoagulant Therapy.2,3 Since RTF does not contain any Quality control
Normal 229 3.0 3.1
contaminating coagulation factors, this PT reagent shows a high sensitivity to Normal and abnormal controls are recommended for a complete quality control Low Fibrinogen Control 157 3.7 4.5
deficiencies of Factors X, VII, V and II, which makes it particularly appropriate for program.6,7 Normal, Low and High Abnormal Controls for Prothrombin Time, Normal,
factors assay of the extrinsic pathway.3 Low Abnormal and Low Fibrinogen Control for Fibrinogen are designed for this program. ACL TOP Family Mean (Fibrinogen mg/dL) CV % (Within run) CV % (Total)
The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic levels of Each laboratory should establish its own mean and standard deviation and should Normal 296 1.4 2.4
heparin. In the PT test, the addition of the tissue thromboplastin (RecombiPlasTin 2G establish a quality control program to monitor laboratory testing. Controls should be Low Fibrinogen Control 135 2.9 3.6
reagent) to the patient plasma in the presence of calcium ions initiates the activation of analyzed at least once every 8 hour shift in accordance with good laboratory practice.
Correlation:
the extrinsic pathway. This results ultimately in the conversion of fibrinogen to fibrin, Refer to the instrument’s Operator’s Manual for additional information. Assay System slope intercept r Reference method
with formation of a solid gel.2,3 For the IL Coagulation Systems only, the Fibrinogen is Refer to Westgard et al for identification and resolution of out-of-control situations.8
quantitated (PT-based method) by relating the absorbance or light-scatter during PT ELECTRA 0.764 3.043 0.979 HemosIL RTF on ELECTRA
Results
clotting to a calibrator.4 PT ACL Family 0.791 2.786 0.989 HemosIL RTF on ACL Family
Patient results may be reported in the following unit: PT ACL Futura/ 0.808 2.890 0.991 HemosIL RTF on ACL Advance
Composition
PT: seconds, % activity, Ratio, INR ACL Advance
Each RecombiPlasTin 2G kit consists of: Fibrinogen “IL Coagulation Systems only”: mg/dL, g/L PT ACL TOP Family 0.801 2.714 0.992 HemosIL RTF on ACL TOP
RecombiPlasTin 2G (RTF): 5 x 8 or 20 mL vials of lyophilized recombinant human
tissue factor, synthetic phospholipids with stabilizers, preservative and buffer. Refer to the instrument’s Operator’s Manual for additional information. Fibrinogen ACL Family 0.935 6.104 0.987 Fibrinogen (PT-Fib based) on ACL
RecombiPlasTin 2G Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous Fibrinogen ACL Futura/ 0.971 10.933 0.978 Fibrinogen (PT-Fib based) on ACL
solution of calcium chloride, polybrene and a preservative. Limitations/interfering substances ACL Advance Futura/ACL Advance
PRECAUTIONS AND WARNINGS: PT results may be affected by many commonly administered drugs and further studies Fibrinogen ACL TOP Family 1.013 -3.630 0.997 Fibrinogen (PT-Fib based) on ACL TOP
Harmful if swallowed (R 22). Avoid contact with skin and eyes (S 24/25). Do not empty should be made to determine the source of unexpected abnormal results.
These precision and correlation results were obtained using specific lots of reagents
into drains (S 29). Wear suitable protective clothing (S 36). Fibrinogen assay results (PT-based method) may be affected by degradation products and controls. A difference in ISI assignment between the Prothrombin Time reagents
RecombiPlasTin 2G contains sodium azide that may form explosive azides in metal (fibrin or fibrinogen) in the plasma assayed.4 will impact the slope results when comparing clotting times in terms of PT seconds.
plumbing. Use proper disposal procedures. No interference on the ELECTRA (PT only), ACL Family and ACL Futura/ACL Advance
Systems up to: In a clinical study on an ACL TOP comparing this reagent to the commercially available
Enter the ISI value from the insert and establish the Mean of the PT Normal Range with HemosIL RecombiPlasTin kit, samples from 207 patients (119 normals and 88 abnormals,
each new lot. Heparin Hemoglobin Triglycerides Bilirubin including 61 patients on Oral Anticoagulant Therapy and 27 patients with various disease
This product is for in vitro diagnostic use. PT 1.0 U/mL 500 mg/dL 720 mg/dL 30 mg/dL states) were evaluated. For fibrinogen, thirteen samples were not included in
calculations due to no result from either the reference or test instrument, bringing the
Preparation FIB 1.0 U/mL 500 mg/dL 675 mg/dL 30 mg/dL total to n=194. The slope for PT seconds was 0.8137, for PT INR was 1.0838 and for
1. Allow each vial of RecombiPlasTin 2G and RecombiPlasTin 2G Diluent to equilibrate No interference on the ACL TOP Family up to: fibrinogen was 0.9805 and the correlation (r) for PT seconds was 0.9934, for PT INR
at 15-25°C for at least 15 minutes before reconstituting the lyophilized reagent with was 0.9945 and for fibrinogen was 0.9946.
the diluent. Heparin Hemoglobin Triglycerides Bilirubin
In an additional clinical study on an ACL 10000 comparing this reagent to the commercially
2. For the RecombiPlasTin 2G (Cat. No. 0020002950) pipette exactly 8 mL of diluent PT 1.0 U/mL 500 mg/dL 1000 mg/dL 30 mg/dL available HemosIL RecombiPlasTin kit, samples from 88 patients (20 normals and 68
(Cat. No. 0020002952) into the 8 mL vial of reagent (Cat. No. 0020002951). For the FIB 1.6 U/mL 500 mg/dL 1000 mg/dL 30 mg/dL patients on Oral Anticoagulant Therapy) were evaluated. The slope for PT seconds was
RecombiPlasTin 2G (Cat. No. 0020003050) pipette exactly 20 mL of diluent 0.7935, for PT INR was 0.9446 and for fibrinogen was 0.9431 and the correlation (r) for
(Cat. No. 0020003052) into the 20 mL vial of reagent (Cat. No. 0020003051). Expected values PT seconds was 0.9887, for PT INR was 0.9881 and for fibrinogen was 0.9832.
DO NOT pour the contents of the diluent vial into the vial of RecombiPlasTin A normal range study was performed using RecombiPlasTin 2G reagent.
2G. Fibrinogen Linearity:
Assay System N Range (units) System
3. Following reconstitution, replace the stopper and swirl gently. Make sure of the
complete reconstitution of the product. Keep the reagent at 15-25°C for 15 to 20 PT ELECTRA 130 9.8 - 12.2 (seconds) ACL Family, ACL Futura/ACL Advance 80 - 700 mg/dL
minutes and invert to mix before use. PT ACL Family 130 9.1 - 12.1 (seconds) ACL TOP Family 60 - 700 mg/dL
PT ACL Futura/ACL Advance 130 9.9 - 12.9 (seconds) Due to many variables which may affect results, each laboratory should establish its
Reagent storage and stability PT ACL TOP Family 130 9.4 - 12.5 (seconds) own Linearity Range.
Unopened reagents are stable until the expiration date shown on the vial, when stored Fibrinogen ACL Family 129 308 - 613 (mg/dL) Thromboplastin certification
at 2-8°C. Fibrinogen ACL Futura/ACL Advance 129 222 - 340 (mg/dL)
Fibrinogen ACL TOP Family 129 276 - 471 (mg/dL) Variable PT results may occur when samples are tested with thromboplastins of various
Stability after reconstitution: 10 days at 2-8°C, 5 days at 15-25°C in the original vial, sources and/or using different techniques (manual, semi/fully automated).10,11 The
10 days at 15°C on the ACL TOP Family, ACL Futura/ACL Advance, ACL ELITE/ELITE Ranges were calculated as recommended by CLSI document C28-A.9 These results ICSH (International Committee for Standardization in Haematology) and the ICTH
PRO/8/9/10000 and ELECTRA Systems and 10 hours at 15ºC on the ACL Classic were obtained using a specific lot of reagent. Due to many variables which may affect (International Committee on Thrombosis and Haemostasis) have proposed the ISI
(100 – 7000) with no stirring. clotting times, each laboratory should establish its own normal range. (International Sensitivity Index) as a standardization to calculate INR (International
Performance characteristics Normalized Ratio) and give comparable PT results for OAT patients.12 Each batch of
For optimal stability remove reagent from the system and store it at 2-8°C in the original RecombiPlasTin 2G reagent is calibrated against a House Standard with an ISI certified
vial. Precision against the correspondent international reference standard (RTF/95) according to the
Instrument/test procedures Within run and total (run to run and day to day) precision was assessed over multiple WHO recommendations.13,14
runs using both normal and abnormal samples. ISI values in the insert sheet are measured using IL Coagulation and ELECTRA
Refer to the appropriate IL/ELECTRA instrument’s Operator’s Manual and/or
Application/Reference Manual for the complete assay procedure instructions. ELECTRA Mean (PT seconds) CV % (Within run) CV % (Total) Systems. Results in INR are automatically given when the ISI value is entered in the IL
Coagulation Systems. The INR is calculated as follows:15
Specimen collection and preparation Normal 12.2 1.3 1.9
Low Abnormal 21.1 1.2 2.6 INR = (Patient’s PT/Mean of PT normal range)ISI
Nine parts of freshly drawn venous blood are collected into one part trisodium citrate. High Abnormal 31.3 1.3 3.4 The ISI values of this lot are reported in the last section of this insert sheet.
Refer to CLSI (formerly NCCLS) Document H21-A4 for further instructions on specimen Therapeutic range
collection, handling and storage.5 ACL Family Mean (PT seconds) CV % (Within run) CV % (Total)
For OAT indications16 and duration of treatment make reference to local guidelines.
Normal 11.7 0.6 1.5
Low Abnormal 21.6 1.0 1.9
High Abnormal 32.9 1.1 2.6

303582 R0 09/2007
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
Instrumentation Laboratory SpA - V.le Monza 338 - 20128 Milano (Italy)
HemosIL™
RecombiPlasTin 2G - 0020002950 (8 mL) / 0020003050 (20 mL) ENGLISH - Insert revision 09/2007

Bibliography / Literatur / Bibliografía / Bibliographie / Bibliografia /Bibliografia

1. Tripodi A, Arbini A, Chantarangkul V, Mannucci PM. Recombinant tissue factor as substitute for 10. Van Rijin JLML, Schmidt NA, Rutten WPF. Correction of Instrument - and Reagent-Based
conventional thromboplastin in the prothrombin time test. Thromb. Haemost. 1992; 67(1): 42-45. in Difference in Determination of the International Normalized Ratio (INR) for Monitoring
2. Rizza CR, Walker W. One-stage prothrombin time techniques. In: Bang NU, Beller FK, Deutsch E, Anticoagulant Therapy, Clinical Chemistry. 1989; 35 (5): 840-843.
Mammen EF, eds. Thrombosis and bleeding disorders. nd
New York: Academic Press, 1971. 11. Ray MJ, Smith IR. The Dependence of the International Sensitivity Index on the Coagulometer used
3. Quick AJ. Hemorrhagic Diseases and Thrombosis. 2 Ed., Philadelphia: Lea and Febiger; 1966. to Perform the Prothrombin Time, Thromb. Haemost. 1990; 63 (3): 424-429.
4. Rossi E, Mondonico P, Lombardi A, Preda L. Method for the determination of functional (clottable) 12. ICSH/ICTH Recommendations for Reporting Prothrombin Time in Oral Anticoagulant Control,
fibrinogen by the new family of ACL coagulometers. Thromb. Res. 1988; 52: 453-468. Thromb. Haemost. 1985; 53 (1): 155-156.
5. Clinical and Laboratory Standards Institute/NCCLS. Collection, Transport and Processing of Blood 13. WHO Expert Committee on Biological Standardization. 33rd Report, WHO Technical Report Series
Specimens for Testing Plasma-Based Coagulation Assays, Fourth Edition, CLSI/NCCLS Document 687; p. 81-105, Geneva, WHO, 1983.
H21-A4; Vol. 23 No. 35. 14. Tripodi A, Chantarangkul V, Negri B, Clerici M, Mannucci PM. International Collaborative Study for
6. Clinical and Laboratory Standards Institute/NCCLS. One Stage Prothrombin Time (PT) Test and the Calibration of a Proposed Reference Preparation for Thromboplastin, Human Recombinant,
Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline, CLSI/NCCLS Document Plain. Thromb. Haemost. 1998; 79(2): 439-443.
H47-A; Vol. 16 No.3. 15. Poller L, Hirsch J. A simple system for the derivation of International Normalized Ratios for the
7. Zucker S, Cathey MH, and West B. Preparation of Quality Control Specimen for Coagulation, reporting of prothrombin time results with North American thromboplastin reagents.
Am. J. Clin. Pathol. 1970; 53: 924-927. Am. J. Clin. Pathol. 1989; 61: 166-169.
8. Westgard JO, and Barry PL. Cost-Effective Quality Control; Managing the Quality and Productivity of 16. Hirsh J, Dalen JE, Deykin D, Poller L. Oral anticoagulants: mechanism of action, clinical
Analytical Process, AACC Press 1986. effectiveness and optimal therapeutic range. Chest 1992;102(4):312S-326S.
9. Clinical and Laboratory Standards Institute/NCCLS. How to Define and Determine Reference
ACL, ACL Futura, ACL TOP and ELECTRA are registered trademarks of Instrumentation Laboratory.
Intervals in the Clinical Laboratory; Approved Guideline, CLSI/NCCLS Document C28-A; Vol. 15 No. 4.
© 2002 Instrumentation Laboratory

Symbols used / Verwendete Symbole / Símbolos utilizados / Symboles utilisés / Simboli impiegati / Símbolos utilizados

In vitro diagnostic medical device Batch code Use by Temperature limitation Consult instructions for use Control Biological risks Manufacturer Authorised representative
In-vitro Diagnostikum Chargen-Bezeichnung Verwendbar bis Festgelegte Temperatur Beilage beachten Kontrollen Biologisches Risiko Hergestellt von Bevollmächtigter
De uso diagnóstico in vitro Identificación número Caducidad Temperatura de Consultar la metódica Control Riesgo biológico Fabricado por Representante autorizado
Dispositif mèdical de diagnostic in de lote Utilisable jusqu’à Almacenamiento Lire le mode d’emploi Contrôle Risque biologique Fabricant Mandataire
vitro Désignation du lot Da utilizzare prima del Températures limites de Vedere istruzioni per l’uso Controllo Rischio biologico Prodotto da Rappresentanza autorizzata
Per uso diagnostico in vitro Numero del lotto conservation Consultar as instruções de Fabricado por Representante autorizado
Data límite de Controlo Risco biológico
Dispositivo médico para utilização Número de lote utilização Limiti di temperatura utilização
em diagnóstico in vitro Límite de temperatura

303582 R0 09/2007
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
Instrumentation Laboratory SpA - V.le Monza 338 - 20128 Milano (Italy)