Fully Automated Intact PINP
A fully automated magnetic particle chemiluminescent assay for intact amino-terminal propeptide of type I
procollagen (PINP). The assay can be used to quantitatively measure intact PINP in human serum or plasma
as an indicator of osteoblastic activity in bone. IDS-iSYS Intact PINP is to be used as an aid in the management
of osteoporosis treatment.
A consensus group from the International Osteoporosis Foundation (IOF) recommends the use of bone turnover markers
for monitoring of anti-resorptive agents and prediction of fracture risk in postmenopausal osteoporosis1. The amino-terminal
propeptide of type I procollagen (PINP) is probably the most specific and sensitive marker of bone formation2. PINP is a
particular useful marker for monitoring the efficacy of osteoporosis therapy with anabolic agents3,4 but it is also one of the
best bone turnover markers for monitoring the efficacy of anti-resorptive therapy5,6. The IOF and the International Federation
of Clinical Chemistry and Laboratory Medicine (IFCC) experts recommend that s-PINP and s-CTX are used as reference
analytes for bone turnover markers in observational and intervention studies7.
Features and Benefits
Detects only trimeric “intact PINP” isoform – which provides an accurate bone formation indicator in renal
impaired patients5.
Excellent correlation to existing Intact PINP RIA method – eliminates costly radioactive licensing and waste disposal.
Combining the Intact PINP with the established IDS-iSYS CTX-I (CrossLaps®) assays from a single sample tube –
provides an effective tool in the monitoring of osteoporosis treatment and identifying patients at increased risk7-9.
Specifications
Format
Calibrators
Controls
Limit of Quantitation*
Dynamic Range
Specificity
Minimum Sample Volume
Sample Type
Reagent Stability
Calibration Stability
Time to 1st Result
Precision*
Automated acridinium ester magnetic particle chemiluminescence
Lyophilised, 2 each of 2 concentration levels, 1 mL
Lyophilised, 2 each of 3 concentration levels, 1 mL
<1.0 ng/mL
2 - 230 ng/mL
Intact PINP
100%
rat/mouse PINP
<0.01%
PIINP
<0.03%
N-MID® Osteocalcin
<0.02%
20 μL plus dead volume
Human serum (including serum collected in serum separator tubes)
Human plasma (collected in potassium EDTA, lithium heparin, sodium heparin, or ammonium heparin)
The IDS-iSYS PINP assay reagent cartridge may be stored on-board the IDS-iSYS System
for a maximum of 7 days; 28 days after opening at 2 - 8 °C
The calibration of IDS-iSYS PINP assay is stable for a maximum of 3 days
34 minutes
Mean
Mean
Within Run
Total**
Sample ID
N
(ng/mL)
(nmol/L)
SD
%CV
SD
%CV
1
2
3
* Representative data; results in individual laboratories may vary from these data.
** Total is an accumulation of within run, between run and between day.
80
80
80
14.3
44.6
101
16.8
64.5
186
0.4
1.3
3.0
2.6
3.0
3.0
0.6
2.4
4.5
4.2
5.3
4.4
Method Comparison
IDS-iSYS vs. Orion UniQ Intact PINP RIA
IDS-iSYS vs. Orion UniQ Intact PINP RIA - Renal Impaired Samples
250
y = 0.86x -1.9
r = 0.98
n = 363
200
IDS-iSYS Intact PINP (ng/mL)
IDS-iSYS Intact PINP (ng/mL)
250
150
100
50
0
y = 0.83x - 0.5
r = 0.99
n = 68
200
150
100
50
0
0
50
100
150
200
0
250
50
Orion UniQ Intact PINP RIA (ng/mL)
100
150
200
250
Orion UniQ Intact PINP RIA (ng/mL)
A total of 363 samples were compared against Orion UniQ Intact PINP RIA. Linear
regression analysis was performed on the comparative data. The IDS-iSYS PINP assay
has good correlation against the Orion UniQ Intact PINP RIA.
In healthy individuals, the circulating PINP form is predominantly the trimeric intact with almost
non-detectable monomers. Under certain conditions, especially in haemodialysis patients, the
proportion of monomeric form is elevated5. 68 renal impaired samples were compared against
the Intact PINP assays. Good correlation was observed between the Intact PINP methods.
Total PINP vs. Orion UniQ Intact PINP RIA - Renal Impaired Samples
Total PINP vs. IDS-iSYS Intact PINP - Renal Impaired Samples
400
400
300
Total PINP (ng/mL)
300
Total PINP (ng/mL)
y = 2.00x - 20.4
r = 0.94
n = 68
y = 1.71x - 24.5
r = 0.95
n = 68
200
100
100
0
200
0
50
100
150
200
Orion UniQ Intact PINP RIA (ng/mL)
0
250
0
50
100
150
200
250
IDS-iSYS Intact PINP (ng/mL)
The same 68 renal impaired samples were compared against Intact PINP and automated Total PINP assay. The comparison studies indicated the automated Total PINP method
give higher values than Intact PINP
Ordering Information
Product Name
Description
IDS-iSYS Intact PINP
IDS-iSYS Intact PINP
Reagent Pack:
Control Set:
Code
100 tests
3 levels
IS-4000
IS-4030
Contact Details
United Kingdom:
Nordic:
Immunodiagnostic Systems Limited (IDS Ltd)
10 Didcot Way, Boldon Business Park,
Boldon, Tyne & Wear, NE35 9PD, UK
Tel: +44 (0) 191 519 0660 Fax: +44 (0) 191 519 0760
Email: [email protected] www.idsplc.com
Immunodiagnostic Systems Nordic a/s (IDS Nordic a/s)
Marielundvej 30, 2. Sal, 2730 Herlev, Denmark
Tel: +45 44 84 0091
Email: [email protected] www.idsplc.com
United States of America:
References
Immunodiagnostic Systems Inc (IDS Inc)
8425 N. 90th Street, Suite 8,
Scottsdale, AZ 85258, USA
Tel: 480.278.8333 Fax: 480.836.7437
Email: [email protected] www.idsplc.com
Germany:
Immunodiagnostic Systems GmbH (IDS GmbH)
Mainzer Landstrasse 49, 60329, Frankfurt am Main, Germany
Tel: +49 (0) 69 3085 5025 Fax: +49 (0) 69 3085 5125
Email: [email protected] www.idsplc.com
France:
Immunodiagnostic Systems France SAS
153 avenue d’Italie, 75013, Paris, France
Tél: +33 (0)1 40 77 04 50 Fax: +33 (0)1 40 77 04 55
Email: [email protected] www.idsplc.com
1.
2.
3.
4.
5.
6.
7.
8.
9.
Delmas PD et al. Osteoporos Int 2000; 11(6):S2–S17.
Melkko et al. Clin Chem 1996; 42:947-954.
Chen et al. J Bone Miner Res 2005; 20:962-970.
Finkelstein JS et al. J Clin Endocrinol Metab 2006; 91:2882-2887.
Koivula et al. Ann Clin Biochem 2010; 47 (1), 67.
Burnett-Bowie S et al. J Clin Endocrinol Metab 2009; 94:2915-21.
S. Vasikaran et al. Osteoporos Int 2010; 22(2):391-420.
Reginster J-Y et al. Bone 2004; 34:344-351.
Scariano J et al. Clin Biochem 2001; 34:639-644.
IS-4000TSIntl
Issue: 1
Date: 28.03.11
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