International Corporation
life. science. discovery. ™
CE Marked
In Vitro
Diagnostics
Anti-RNA
Polymerase III
•Aids in the diagnosis of Systemic
Sclerosis (SSc)
• For in-vitro diagnostic use
• Semi-quantitative ELISA kit
• High Sensitivity
Anti-RNA polymerase III antibody is a highly specific marker for SSc.1
A recent large cohort study reported that 13.2% of more than 2,000 patients
with SSc were positive for anti-RNA polymerase III antibodies,2 a
higher prevalence than had been previously reported.3,4
Lungs
The presence of the anti-RNA polymerase III (RNAP III) antibodies is
strongly associated with a poor patient prognosis.3 Patients with
anti-RNA polymerase III are more likely to develop rapidly progressive
renal failure than SSc patients lacking RNAP III antibodies. In addition,
anti-RNA polymerase III may be associated with an increased cancer risk
among SSc patients.2,4
Heart
Kidneys
Skin
Clinical consistency with immunoprecipitation (Gold standard)
Immunoprecipitation
positive
Japan
S.Korea
"Anti-RNA Polymerase III ELISA Kit"
USA*
Total
negative
positve
17
3
negative
0
245
positve
28
1
negative
2
165
positve
64
-
negative
73
-
positive
109
4
negative
11
162
*All sera from US lab were positive for anti–RNA polymerase III (anti–RNAP III) antibody by immunoprecipitation assay.
Sensitivity
Specificity
Positive predictive value
Negative predictive value
91%
99%
96%
97%
15A Constitution Way, Woburn MA 01801,USA
•
T: 800.200.5459 F: 781.939.6963
•
mblintl.com
Anti-RNA polymerase III antibody titers in SSc and control patients
600
Anti-RNAP III antibody (U/mL)
Systemic Sclerosis (SSc)
Systemic sclerosis (SSc) or systemic scleroderma
is a chronic multisystem connective tissue disease.
Prevalence of SSc varies worldwide, and recent
studies reported to be 88 to 443 cases per
1,000,000 people.5 SSc can be subcategorized into
several subsets.
Antinuclear antibodies (ANA’s) are present in sera
of nearly all patients with SSc. The three major
characteristic autoantibodies of SSc target to
topoisomerase I (Scl-70), centromere proteins like
CENP-B, and RNA polymerase III. The detection
of these antibodies is strongly supportive for the
diagnosis of SSc and prediction of its subsets.
500
400
300
200
100
0
SSc diffuse
SSc limited
Non SSc
Normal
In 2013, these SSc-related autoantibodies have been
incorporated into new classification criteria for SSc
provided by the American College of Rheumatology
(ACR) and European League Against Rheumatology
(EULAR).6
SSc Subsets
Clinical features
• Skin manifestations are restricted to the hands and the distal forearms
• Formerly identified as CREST * syndrome
Limited SSc
• Association with autoimmune hepatitis (AIH) and primary biliary
cirrhosis (PBC)
• Skin manifestations are also present in the proximal extremities and
trunk of the body
Diffuse SSc
• Worse prognosis and faster disease progression than Limited SSc
• Association with renal crisis (rapidly progressive renal failure)
SSc without
skin involvement
Overlap syndrome
Internal organs involvement only
Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and
inflammatory myopathy are associated with SSc
*CREST syndrome: Calcinosis, Raynaud’s phenomenon, Esophageal dysmotility, Sclerodactyly, and Telangiectasias
1. Kuwana M, et al. Arthritis Rheum. 37: 75-83, 1994 [PubMed: 8129766] • 2. Moinzadeh P, et al. Res. Ther. 16: R53, 2014 [PubMed: 24524733] • 3. Satoh T, et al.
Rheumatology. 48: 1570-1574, 2009 [PubMed: 19808694] • 4. Airo‘ P, et al. Rheumatol. 38: 1329-1334, 2011 [PubMed: 21459934] • 5. Barnes J, et al. 24: 165-170,
2014 [PubMed: 22269658] • 6. van den Hoogen F, et al. Ann. Rheum. Dis. 72: 1747-1755, 2013 [PubMed: 24092682]
Code No.
RG-7836EC-D
Product
Size
Anti-RNA Polymerase III ELISA Kit
48 well
For sale in the EU only. Not for sale in the U.S
15A Constitution Way, Woburn MA 01801,USA
•
T: 800.200.5459 F: 781.939.6963
•
mblintl.com
MC-IVD-006 4/16