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IMMULITE 2000 Anti-CCP IgG
Clinical
Non-
Status
Reac
Reac Sensitivity Specificity
Positive
201
56
Negative
1
199
References
1) Yelin E, Callahan LF. The economic cost and
social and psychological impact of
musculoskeletal conditions. Arthritis Rheum.
1995;38:1351-62. 2) Kroot EJJA, de Jong BAW,
van Leeuwen MA, et al. The prognostic value of
anti-cyclic citrullinated peptide antibody in
patients with recent-onset rheumatoid arthritis.
Arthritis Rheum. 2000;43:1831-5. 3) Bizzaro N,
Mazzanti G, Tonutti E, et al. Diagnostic accuracy
of the anti-citrulline antibody assay for
rheumatoid arthritis. Clin Chem. 2001;47-1089-
93. 4) Visser H, Cessie S, Vols K, Breedveld F,
Hazes J. How to diagnose rheumatoid arthritis
early. Arthritis Rheum. 2002;46:357-65.
5) Girbal-Neuhauser E. Durieus JJ, Arnaud M, et
al. The epitopes targeted by the rheumatoid
arthritis-associated anti-filaggrin autoantibodies
are postranslationally generated on various sites
of (pro)filaggrin by deimination of arginine
residues. J Immunol. 1999;162:585. 6) Vincet C,
Simon M, Sebbag M, et al. Immunoblotting
detection of autoantibodies to human epidermis
filaggrin: a new diagnostic test for rheumatoid
arthritis. J Rheumatol. 1998;25:838-46.
7) Silveira I.G., Burlingame R.W., von Muhlen
C.A., Bender A.L. and Staub, H.L. (Feb 2007).
"Anti-CCP antibodies have more diagnostic
impact than rheumatoid factor (RF) in a
population tested RF." Clin. Rheumatol. DOI
10.1007/s10067-007-0601-6. 8) Avouac J,
Gossec L, Dougados M (July 2006). "Diagnostic
and predictive value of anti-cyclic citrullinated
protein antibodies in rheumatoid arthritis: a
systematic literature review." Ann. Rheum. Dis.
65 (7): 845–51. 9) Data on file at
Siemens Healthcare Diagnostics. 10) CLSI.
Protocols for the Determination of Limits of
Detection and Limits of Quantitation; Approved
Guideline. CLSI document EP17-A Vol. 24 (No.
34). CLSI, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898, USA, 2004.
11) Clinical and Laboratory Standards Institute
(formally NCCLS). Evaluation of Precision
Performance of Clinical Devices; Approved
Guideline. Wayne PA: Clinical and Laboratory
Standards Institute; 1999. NCCLS Document
EP5-A. 12) Arnett FC, Edworthy SM, Bloch DA,
et al. The American Rheumatism Association
1987 revised criteria for the classification of
rheumatoid arthritis. Arthritis Rheum
1988;31(3):315-24. 13) Centers for Disease
Control. Update: Universal precautions for
prevention of transmission of human
immunodeficiency virus, hepatitis B virus and
other bloodborne pathogens in healthcare
settings. MMWR, 1988;37:377–82, 387–8.
IMMULITE 2000 Anti-CCP IgG (PIL2KPI-15, 2022-02)
78.2%
99.5%
14) Clinical and Laboratory Standards Institute
(formerly NCCLS). Protection of Laboratory
Workers From Occupationally Acquired
Infections; Approved Guideline - Third Edition.
Wayne, PA: Clinical and Laboratory Standards
Institute; 2005. NCCLS Document M29-A3.
15) Federal Occupational Safety and Health
Administration, Bloodborne Pathogens
Standard, 29 CFR 1910.1030.
Technical Assistance
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Tables and Graphs
Precision (U/mL) – Serum Pool
Within-Run
Mean
3
SD
4
%CV
1
2.77
0.25
2
4.93
0.21
3
8.92
0.34
4
38.6
1.58
5
148
5.54
1
Intra-Assay,
Deutsch. Precision:
3
4
Mittelwert,
SD (Standardabweichung),
5
CV (Variationskoeffizient).
1
Intraensayo,
Español. Precision:
3
4
5
Media,
DS,
CV.
1
Intraessai,
Français. Precision:
3
4
5
Moyenne,
SD,
CV.
1
Intra-serie,
Italiano. Precision:
4
SD (Deviazione Standard),
Variazione).
1
Entre-ensaios,
Português. Precisão:
3
Média,
4
Desvio padrão,
5
Coeficiente de
variação.
1
2
Total
5
SD
%CV
9.0
0.51
18.5
4.3
0.45
9.1
3.8
0.53
5.9
4.1
2.21
5.7
3.7
8.15
5.5
2
Gesamt,
2
Total,
2
Total,
2
Totale,
3
Media,
5
CV (Coefficiente di
2
Total,
7
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