UniQ RIA

PINP - aminoterminal propeptide of type I procollagen - is a specific type I collagen metabolite which is liberated into the blood stream during the formation of new bone. Its concentration is directly related to the rate of bone turnover. In metabolic bone diseases such as osteoporosis, PINP is a sensitive indicator for identifying patients with a high rate of bone turnover and, consequently, at high risk of fracture. PINP is a useful parameter for monitoring the effectiveness of anti-resorptive and anabolic treatment.

ICTP - carboxyterminal telopeptide of type I collagen - is a crosslinked product of collagen degradation, which is released from bone when it is being degraded under pathological conditions.

ICTP can be used to monitor diseases involving pathological degradation of bone, such as cancers that metastasise to bone, rheumatoid arthritis and multiple myeloma.

PIIINP - aminoterminal propeptide of type III procollagen - is liberated into the circulation during soft tissue formation. Changes in PIIINP levels reflect the involvement and altered metabolism of type III collagen, which is common in many connective tissue disorders.

PIIINP can be used to assess and monitor fibrotic processes in liver diseases, thus avoiding the need for liver biopsies. It is also useful for monitoring growth hormone therapy in children with growth disorders. PIIINP gives prognostic information on cardiac disease and reflects the healing process.

UniQ tests provide you with

A specific and sensitive means for assessing the metabolism of bone and soft tissues.

PINP

• Monitoring the effect of osteoporosis treatment
• Selecting the most effective treatment
• Monitoring patient compliance
• A dynamic marker showing the rate of bone turnover
• Changes in bone turnover seen in a couple of months

ICTP

• Early detection of skeletal bone metastases in breast, lung and prostate cancers
• Detection of minor changes in bone turnover much earlier than bone scan
• Reveals osteolytic bone lesions in multiple myeloma years before they are radiologically detectable
• Early detection of rheumatoid patients needing intensified treatment

PIIINP

• Monitoring of fibrosis, especially in the liver and heart
• Patient-friendly, non-invasive method for monitoring methotrexate treated psoriatics
• Bringing cost savings to health economy by decreasing the need for liver biopsies
• Prognostic marker in cardiac failures

Test results should never be used alone, without a complete clinical evaluation.

UniQ PINP RIA registered in the USA. UniQ PIIINP RIA and UniQ ICTP RIA are not registered in the USA.

Collagen is the most common protein in the human body. It provides structural support to bone, skin, muscle and tendons. Monitoring the metabolism of collagen from serum samples can be used to detect and manage a range of different bone and soft tissue disorders.

Increased serum concentrations of ICTP are seen in conditions associated with increased lysis of bone, such as multiple myeloma, osteolytic metastases, rheumatoid arthritis and immobilisation. PINP measurements provide a sensitive tool for assessing increased bone turnover in postmenopausal women and may be particularly useful for monitoring the effect of antiresorptive and anabolic therapy on bone metabolism. Liver fibrosis and cirrhosis of various aetiologies increase serum concentrations of PIIINP. PIIINP provides a non-invasive means of monitoring the effect of methotrexate treatment on the livers of psoriasis patients.

In osteoporosis the gold standard measurement is bone mineral density, which is a static measure of the patient’s current bone status and therefore does not give information about the rate of bone turnover. This, on the contrary, can be achieved by measuring PINP. Monitoring the effect of an osteoporosis treatment with bone mineral density takes usually two years before a significant response can be detected. With the UniQ PINP kit the information is available in a couple of months.

Breast, lung and prostate cancer often metastasize to bone. In the follow-up of cancer patients early detection of metastases is critically important. UniQ ICTP is an early serum marker of skeletal metastases providing valuable information of the progression of the disease.
Measuring ICTP in multiple myeloma, a malignant bone disease, gives valuable information about prognosis. Selection of a most efficient treatment in rheumatoid arthritis can be done by measuring serum ICTP.

Liver fibrosis induced by methotrexate treatment of psoriatic patients can be monitored, instead of an expensive and high risk liver biopsy, by measuring serum PIIINP at regular intervals. Measuring serum PIIINP is a patient-friendly and health economical way of monitoring liver fibrosis.
In chronic hepatitis C patients with advanced fibrosis, PIIINP gives valuable information about changes in fibrosis during and after antiviral therapy, as well as provides prognostic information.
The measurement of PIIINP as a marker of cardiac extra cellular matrix turnover has value as a prognostic predictor. High baseline serum PIIINP concentrations are associated with an increased risk of death and death+hospitalization.

The UniQ PINP kit is intended to be used as an aid in the management of postmenopausal osteoporosis. Short-term changes in PINP are associated with longer-term changes in bone mineral density in postmenopausal women. Monitoring PINP concentrations during osteoporosis treatment provides a rapid assessment of a patient’s response to osteoporosis therapy.

UniQ ICTP is an early marker of bone metastases in breast, lung and prostate cancer. It becomes elevated months before lesions become radiologically detectable.

The UniQ PIIINP test provides a means of monitoring development of fibrosis, especially in the liver and heart, in a patient-friendly and cost-effective way.

Marketing and sales materials

UniQ Bone and Tissue Markers Family Brochure (EN)

UniQ PINP RIA Monitoring of osteoporosis treatment (EN)

UniQ PIIINP RIA Application Sheet Liver Fibrosis (EN)

UniQ PIIINP RIA Application Sheet Cardiac Disease (EN)

UniQ ICTP RIA Application Sheet Bone Metastases (EN)

Stories

Monitoring treatment of methotrexate in psoriasis patients (EN)

The value of PINP measurements in the diagnosis and treatment of osteoporosis (EN)

Use of the UniQ® ICTP RIA kit in monitoring bone metastasis of cancer (EN)

Instructions for use

(For informative use only. Kindly always refer to the latest package insert in the kit.)

UniQ PINP RIA IFU (GB, DE, FR, NL, ES, IT, CZ, PL, SE, NO, DK), 67034

UniQ PIIINP RIA IFU (GB, DE, FR, NL, ES, IT, CZ, PL, SE, NO, DK), 68570

UniQ ICTP RIA IFU (GB, DE, FR, NL, ES, IT, CZ, PL, SE, NO, DK), 68601

Safety Data Sheet

Can you measure changes in cartilage metabolism with the UniQ Bone & Tissue markers?

Cartilage is mainly composed of type II collagen. As our assays measure type I and type III collagen, none of the assays can be used for measuring changes in cartilage metabolism.

Are there any substances in blood that can react with the UniQ Bone & Tissue Marker assays?

The only substances in blood that could be expected to react with the collagen assays are other peptide fragments. The antiserums used in the UniQ PINP, PIIINP and ICTP assays do not cross react with antigens used in other UniQ Collagen assays. The PINP assay has a low cross reactivity (2.7%) with Col1, a small molecular weight monomeric degradation product of the PINP propeptide.

What types of test tube should be used when running the UniQ RIA kits?

We recommend using polystyrene test tubes for the UniQ PINP RIA and ICTP RIA assays. For UniQ PIIINP RIA both polystyrene and polypropylene test tubes can be used.

How are the collagen markers cleared from the blood circulation? Are there any conditions which can affect their clearance from the patient?

PINP and PIIINP are cleared from the circulation through a specialised part of the reticulo-endothelial system, the endothelial cells of the liver. These cells bind and internalise the propeptides by receptor-mediated endocytosis using scavenger receptors. Severe liver disease can affect the clearance of PINP and PIIINP. As renal insufficiency does not affect the concentration of the propeptides they are very useful for monitoring changes in collagen metabolism in patients with renal failure.
ICTP is cleared from the circulation through the kidneys. Renal insufficiency does not greatly affect the circulating concentration of ICTP because a glomerular filtration rate of two-thirds of the normal rate is still sufficient to remove ICTP. When the glomerular filtration rate is 50 ml/min/1.73 m² or less, the ICTP concentration in blood becomes elevated.

What is the molecular weight of PINP, ICTP and PIIINP?

The molecular weight of the PINP antigen is approximately 35,000 Dalton, whereas PIIINP is about 42,000 Dalton. The propeptide fragments found in blood are about the same size.
For the ICTP antigen, it is more difficult to give an exact weight: depending on the mode of determination (amino acid sequencing or SDS-Page), the molecular weight varies between 8,800 and 13,000 Dalton. The ICTP antigen is purified from mature bone through enzymatic digestion, so therefore the exact size of the antigen might also somewhat vary from time to time. Generally, you could say that the ICTP antigen used in the kit is around 10,000 Dalton. In blood, the ICTP fragment is probably somewhat smaller.

How should serum samples be stored and how stable are the collagen markers in samples?

The collagen markers are very stable in serum samples. Samples can be kept at room temperature for some days without significantly affecting the concentration of the markers and may be stored for up to 5 days at 2...8 °C. Storage for longer periods should be at temperatures of at least -20 °C. Freezing and thawing (4 times) does not affect the quality of the sample.

Can the UniQ Bone & Tissue Markers be detected in cell culture medium?

In cell cultures of fibroblasts, PINP and PIIINP are produced. As the propeptide assays do not distinguish between free propeptide and propeptide still bound to the helical procollagen structure, the assays can measure both these forms of propeptide which are commonly found in cell cultures. The trivalently cross-linked ICTP structure is not likely to be found in fibroblast cultures. If osteoclasts are cultured on bone slices, the ICTP fragment is, however, likely to be found in the cell culture medium in response to degradation of old, mineralised bone matrix.

Can PINP, ICTP and PIIINP be found in urine and different biological fluids?

Aidian has developed the kits for serum use. There are, nevertheless, publications and research works where the kits have been used with other human fluids. Aidian has not validated the kits for other than serum, and does not have reference values available for other biological fluids than serum.
None of the markers can be detected in urine, as the fragments recognised by the assays are not found in urine due to their metabolism in the liver or the kidneys.
In the list below we have collected some information about other human biological fluids. The information in the list is indicative only.

Can the human UniQ Bone & Tissue Marker assays be used for assessing collagen metabolism in animals?

Aidian has developed and validated the kits for human serum use. There are, nevertheless, publications and research works where the kits have been used with various animal samples. Aidian does not have reference values available for other sample material than human serum. In the list below there is data collected from publications. The information in the list is indicative only.

Yes implies that the cross-reaction between the antibody used in the assay and the animal antigen should be sufficient to allow the assay to be used for that animal. No means that the antibody and the animal antigen may cross-react, but not enough to produce values in the range of the assay, or then that there seems to be no cross-reaction at all. Blank cells denote no information received.

What is the best way to process the results of UniQ assays?

The best way to process the results is to use spline function curve fitting with a linear Y-axis and a logarithmic X-axis.

What is the amount of radioactivity in the kits?

The amount of radioactivity in each UniQ kit is less than 200 kBq.