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CheckoutOsteoporosis Screening Test - Instructions
Self Test – For Home Use
IN-VITRO DIAGNOSTIC USE ONLY - NOT
FOR INTERNAL USE
Why do this test?
The intended use of this test is to monitor the amount of a specific chemical produced by cells involved in maintenance of bone tissue, it is generated by a protein known as bone collagen excreted in freshly voided early morning urine samples provided by the user of this screening kit. Increased levels of the chemical (known as Dpd*) measured in early morning urine samples are a reliable indicator of increased cellular activity and changes in bone tissue. Regular measurement allows the effectiveness of treatment such as HRT and specialised dietary regimes to be assessed easily and reliably over time.
- Because Osteoporosis can make you more susceptible to fractures of the hip, spine and wrist.
- Because there is now an accurate test for the detection of Osteoporosis using a urine sample.
- Because Osteoporosis is a disease that can be prevented and treated given early detection.
* (see further down this document for further information on the term Dpd)
Please note that this product is a screening test and should not be used in isolation either to diagnose or exclude the presence of the condition known as osteoporosis.
OSTEOPOROSIS ADVICE
Bone is a living tissue that is constantly being renewed and destroyed in a process called resorption.
This cycle of resorption ensures that maintenance of healthy bone. Special cells called OSTEOCLASTS assist in bone resorption or destruction, whilst cells called OSTEOBLASTS form new bone. When the new bone is formed it is coated with minerals, living cells and a protein called Collagen. The complete process of regeneration and replacement takes about 100 days.
As a by-product of the process of resorption substances called bone markers are excreted in urine, and can be measured by this test. The more bone marker that is excreted in the urine, the higher the risk of bone loss and fracture.
It is the measurement of bone marker that is used as an indicator of bone loss. As more bone is lost, the bone marker level in the urine increases. Osteoporosis is a disease where there is a low bone density, and high deterioration of bone tissue. Both men and women can suffer from Osteoporosis and are susceptible to fractures of the hip, spine and wrist.
This test should be seen in the context of a wider programme of clinical determination and management, including the use of ultra-sound scans, these can be arranged through your GP (General Practitioner) .
This test relies upon detection in a biological system therefore it is possible that it may not be 100% accurate in every case. Occasionally the test may produce a false positive or a false negative result. As with all screening tests therapeutic decisions should not be basedon any single result or method. In the case of unexpected results or symptoms, consult your doctor or pharmacist for advice.
A single result in isolation may not be clinically conclusive.
Check that your kit contains:
- Plastic pouch with snap top seal and two pockets.
- A plastic postal tube, lined with an absorbent material in case of leakage
- A urine sample bottle with a screw top
- Client Information Form
- Results Interpretation leaflet
- Postage paid envelope addressed to:
TDL
60 Whitfield Street
London
W1E 4BR
- Check that the test reference number on the sample bottle and client information form are the same, if not then do not proceed. Contact the supplier for a replacement test.
The number is unique and has been allocated to you. Please keep a note the reference number used on the client information form in case you need to contact us.
INSTRUCTIONS FOR USE
Please read these carefully before proceeding
(Not
recommended for persons under 18 years of age)
Please take the time to read this information sheet telling you about Osteoporosis, particularly regarding the advice as to what you should do when you receive your results.
A urine specimen is required to test for Osteoporosis. The laboratory is closed on Sundays, so to minimise the chances of any delay in processing your sample, we advise that you collect a urine sample in the morning, Monday to Wednesday and post it as soon as possible after collection.
The urine sample must not be kept at room temperature for longer than necessary – if there is likely to be any delay in posting, please place it in the fridge (not freezer). The sample must be processed within 4 days.
Collecting the urine sample
Do not collect until at least one hour has elapsed since you last passed urine, it may be easier to collect it first thing in the morning.
- Remove the screw top from the sample collection bottle. Start to urinate into the bottle, making sure that you catch the first drops of urine you pass. Continue until the bottle is about three quarters full (approx 20mls of urine), then finish urinating into the toilet. The urine sample must be the first of second sample of the day.
- Screw the top back onto the bottle tightly to avoid leakage during transport.
- Write your name, date and time of collection of the sample on the bottle in the space provided.
- Complete the client information form with your name, address etc. and especially the date and time of collection of the sample.
- Place the bottle into the plastic tube, close by pressing the plastic ends together firmly.
- Place the plastic tube into one side of the plastic pouch and place the client information form in the pouch on the other side. Seal the pouch by pressing the edges of the plastic together to seal.
- Place the plastic pouch inside the plastic postal envelope and seal by peeling of the dividing plastic strip and press the edges on the adhesive to seal.
- This envelope is pre-addressed and pre-paid. Post it as soon as you can.
Interpretation of Results
An early morning urine sample will be tested using one a number of biochemical markers currently available to help determine Osteoporosis by monitoring the minute levels of chemicals associated with bone resorption using a bone marker deoxpyruidinoline (Dpd)
(*Resorption is the process of bone loss produced resulting from cellular activity occurring in the bones).
Dpd bone marker assays and the results obtained should not be regarded as a single diagnostic test. Factors such your age and family history and the results of other clinical investigations should also be taken into consideration when assessing the likelihood of Osteoporosis being present. A formal diagnosis should only be made in consultation with your GP or other healthcare professionals who will be able to provide further information on the treatment and management of the condition.
Results obtained:
The results of the test supplied by the laboratory analysis are printed on the result form as a simple two digit numeric value indicating the level or amount of Dpd detected in the urine sample tested.
Results will conform (or fit) in to distinct bands;
Firstly a band termed the “normal range” (the normal range is shown separately for both men and women on the results form).
Alternatively the results (Dpd level) obtained may be outside of the normal range indicating either higher or lower levels of Dpd in the test sample.
The results from the laboratory are sent to you directly and you should use the ‘results interpretation’ leaflet enclosed,. as well as answering some of the most frequently asked questions relating to the analysis. It is recommended that the results obtained are discussed with your GP or medical advisor to ensure that the appropriate care regimen can be established.
Test out of protocol
On rare occasions samples may be found to be out of protocol due to extended periods in the postal system that in effect renders the test invalid. You will be sent a letter informing you with a replacement sample kit FOC so that you can provide another sample for analysis.
It is important to remember that results should not be interpreted as simply “positive or negative”. In any eventuality the results of laboratory test should be discussed in detail with your GP or healthcare advisor. A single test result can only provide a base line further tests may need to be carried out in order to monitor the effectiveness of therapeutic treatment including the use of HRT therapy etc.
If you do not receive your results within 14 days of posting the sample please contact the Simplicity Health Ltd. Helpline on: 08700 349 606 or by e-mail : info@simplicityhealth.co.uk
How do I receive my results?
- In order to receive your results promptly, please ensure that your name and address is clearly written on the client information form. A hard copy of the result will be sent to your home address.
- You will not be given your results by telephone.
- If you require any further information please contact your GP (General Practitioner) or Pharmacist, who will be more able to assist you in more detail.
- This advice is in no way meant to replace qualified medical advice.
