Stockholm3 test for risk evaluation of prostate cancer
Stockholm3 is a blood test that helps to predict risk of clinically significant prostate cancer in men aged 45–74 years with a PSA level greater than 1.5 ng/ml where no previous diagnosis of prostate cancer has been made. Stockholm3 combines genetic markers, proteins and clinical data in an algorithm to help identify clinically significant prostate cancer. It allows for screening in primary or secondary care settings and is equivalent across diverse populations to reduce unnecessary invasive diagnostic procedures.
Click to view Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection Abstract*
Stockholm3 has been prospectively validated in more than 90,000 men with results published in more than 30 peer reviewed articles. The test provides clear, interpretable results (High risk, Normal risk, Low risk) and treatment recommendations.
EUA references Stockholm3 explicitly: ‘The Stockholm3 test is a prediction model that is based on several clinical variables (age, first-degree family history of PCa, and previous biopsy), blood biomarkers (total PSA, free PSA, ratio of free PSA to total PSA, human kallikrein 2, macrophage inhibitory cytokine-1, and microseminoprotein-β), and a polygenic risk score for predicting the risk of PCa with ISUP grade group ≥ 2, and was shown to reduce the percent of clinically insignificant cancers when used in combination with MRI in a PSA screening population. It also has the potential to decrease the number of mpMRI scans required in prostate cancer screening.’
Key characteristics of Stockholm3
- Increased early detection – increased sensitivity
- Increased specificity reduces over testing, unnecessary biopsies by 50% and treatment
- Higher accuracy compared to PSA, PSAD and prostate cancer risk calculator
- Can distinguish between aggressive and benign tumours in a way that PSA testing cannot
- Validated in combination with MRI and in multiple ethnicities
- Shown to detect clinically significant prostate cancers in PSA levels of 1.5–2.9 ng/ml
- Reduces healthcare costs
Stockholm3: diagnostic patient pathway, including STKR (reflex testing to STK3 from PSA with results of >1.5)
|
Gender |
Male |
|---|---|
|
Intended age |
45–74 years, not had prostate cancer, PSA >1.5 ng/ml |
|
Clinical data required |
Age, family history of prostate cancer, previous biopsies, use of 5-alpha reductase inhibitors (Avodart [Dutasteride] or Proscar [Finasteride]. |
|
Test code STK3 |
2 x EDTA tubes must be received within 24–36 hours of sample taking. TAT up to 2 weeks |
|
Test code STKR |
PSA levels of >1.5 combined with reflex testing to STK3. 1 x SST, 2 x EDTA tubes must be received within 24–36 hours of sample taking. TAT up to 2 weeks. |
A Stockholm3 risk score of >11 is considered to be an indicator of clinically significant prostate cancer risk and referral to a urologist for further investigation is recommended.
For further information about the test or to order sample collection kits please contact stockholm3@tdlpathology.com. Do not post samples to TDL – these packs do not include a reply-paid envelope. The timing for receipt of samples within 24–36 hours is important.
The next Stockholm3 Webinar will be on Wednesday 11th September at 15.00.
Please register for this through stockholm3@tdlpathology.com.
* Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial Authors: Hari T. Vigneswaran, Martin Eklund, Andrea Discacciati, Tobias Nordström, Rebecca A. Hubbard, Nathan Perlis, Michael R. Abern. https://doi.org/10.1200/JCO.24.00152.
Testing for Bordetella Pertussis (whooping cough) by PCR
TDL has introduced in-house testing for pertussis (whooping cough) by PCR. Bordetella pertussis is a notifiable disease – notification should be made to UKHSA at the point of suspicion of infection. The recent increase in pertussis cases has been seen across all age groups and in every region in England.
Initial symptoms resemble a cold and may include a runny nose and sore throat. After about a week the infection can develop into coughing bouts that last a few minutes. The method of diagnosis varies depending on the time since last pertussis vaccination, or the duration of the cough and may include PCR analysis of a nasopharyngeal swab or serology for antibody titres. Recommended tests for B. pertussis vary according to the length of time from cough onset.
Molecular testing (PCR) is more sensitive than culture for the detection of acute B. pertussis infection and is the gold standard test for early infection.
This new in-house PCR test also detects Bordetella parapertussis and Bordetella holmesii. Results for the three species, plus an interpretative comment will be given. These non-pertussis species of Bordetella can cause very similar symptoms to Bordetella pertussis, including a whooping cough-like picture, and can cause clusters of infection. Unlike Bordetella pertussis, these non-pertussis species are not notifiable but it is advised that positive results are communicated to your local Health Protection Team if the patient is part of a cluster of infections.
Important information
The in-house test can only be tested on Dry PCR Nasopharyngeal Swabs. Samples received in viral transport medium or universal transport medium will be referred to an external laboratory for testing; these samples will not benefit from the improved turnaround time.
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Time since |
Optimal test |
Comments |
|---|---|---|
|
<14 days |
Pertussis (Whooping Cough) by PCR – PERP |
PCR = gold standard test. Culture lacks sensitivity, particularly after first week of illness. |
|
14–21 days |
Pertussis (Whooping Cough) by PCR – PERP |
PCR = gold standard test. Culture lacks sensitivity, particularly after first week of illness. |
|
>21 days |
Pertussis (Whooping Cough) Antibodies – PERS |
Antibody levels can be confounded by recent vaccination. |
Click here to view the TDL Service Update B. Pertussis diagnostic testing PDF
Ziwig Endotest®
The Ziwig ENDOTEST for endometriosis was reinstated in June 2024 with turnaround times of 2–3 weeks. Saliva sample collection kits issued during 2023 that may not have been used will shortly be reaching their expiration date.
- Please replace the kits that have not been used with new in-date kits.
- To order replacement kits, please fill out and return the order form to endotest@tdlpathology.com
- On receipt of your new kits, please discard those that have not been used.
Any saliva samples that are collected using out-of-date kits will have to be discarded.
Click here to download the TDL Endotest Request Form
Click here to download TDL Endotest Sample Taking Instructions
The Ziwig Endotest won International Prix Galien 2024 in the category ‘Best Medical Technology Product with greatest potential impact on human health’. This recognition by International Prix Galien confirms international contribution to diagnosis of this condition.
The average time it takes for a symptomatic woman to receive a diagnosis of endometriosis is now 8 years and 10 months, Symptoms can include chronic pelvic pain, dysmenorrhoea, infertility, dyspareunia, dysuria, dyschezia and fatigue. 1 in 10 women worldwide are affected by endometriosis, affecting from puberty to menopause and beyond.
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Test |
Code |
Sample Reqs |
TAT |
|---|---|---|---|
|
Ziwig Endotest |
ENDT |
Saliva for MicroRNA testing Saliva collection kit provided by TDL – please contact endotest@tdlpathology.com to order kits |
2–3 weeks |
2C19 Clopidogrel genetic test
Approximately 100,000 people in the UK each year will have a stroke, TIA or myocardial infarction. Clopidogrel is an antiplatelet drug which prevents platelets from sticking together and forming a clot. However, 30% of all patients in the UK (and up to 60% in different ethnic groups) have a change in the CYP2C19 gene which reduces clopidogrel’s effectiveness.
Individuals carrying changes in the CYP2C19 gene are also twice as likely to have further strokes when treated with clopidogrel. If these genetic changes can be detected before treatment, then doctors can use an alternative, more effective medicine, reducing time spent in hospital, prevention of further strokes, and avoid future hospital admissions. This will save lives.
NICE guidance recommends that patients to be prescribed Clopidogrel to reduce their risk of stroke recurrence should first be offered genotype testing to determine whether the drug will be effective.
The test detects variations in the CYP2C19 gene which determine whether a patient may be resistant to Clopidogrel. Certain CYP2C19 gene variations may affect the effective metabolism of Clopidogrel, reducing its ability to lower the risk of a further stroke, TIA or myocardial infarction. Treatment with an alternative antiplatelet therapy should be considered.
Test: Cytochrome P450 2C19
Utility: Provides information as to how effectively a person can metabolise the antiplatelet drug Clopidogrel and be used to guide antiplatelet treatment.
Alternative names:
- Clopidogrel resistance testing
- CYP2C19 Genotyping
- Cytochrome P450 2C19
|
Test |
Code |
Sample Reqs |
TAT |
|---|---|---|---|
|
Cytochrome P450 2C19 |
2C19 |
1 x EDTA |
10 days |
Platelet studies are available for cases where efficacy rather than resistance is in question. They require prior arrangement with the Haemostasis Laboratory. Samples for platelet studies have a very short stability time and must be collected by special arrangement. Please contact Deepak Singh (Haemostasis Head of Department) to arrange additional anti-platelet testing if required. Email Deepak.singh@tdlpathology.com
LC MS Mass Spec Total Testosterone
Testosterone must be the world’s most discussed hormone, but general understanding about testing is much less well known. Immunoassay methods are widely used to measure testosterone, providing a reliable method of measurement in many use cases. However, whilst this is accepted for standard testing, this methodology carries a possibility of analytical interference and cross-reactivity with structurally similar biological compounds, which can lead to a false, overestimation of circulating testosterone concentration.
Measurement of total testosterone by tandem mass spectrometry (LC-MS/MS) is a methodology with greater specificity, providing a more accurate measurement of testosterone, important when assessing lower levels of testosterone found in females, children and hypogonadal males.
The British Menopause Society recommends LC-MS/MS for the measurement of total testosterone levels, both to exclude high baseline concentrations before treatment is commenced and to ensure that levels remain within the female physiological range when monitoring supplementation (https://thebms.org.uk/wp-content/uploads/2022/12/08-BMS-TfC-Testosterone-replacement-in-menopause-DEC2022-A.pdf)
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Test |
Code |
Sample Reqs |
TAT |
|---|---|---|---|
|
LC MS Mass Spec Total Testosterone |
MSTT |
1 x SST |
5-7 days |
|
Female Reference Ranges |
0.7–2.8 nmol/L (normal) |
|
|
0–0.7 (low) |
||
|
Male Reference Ranges |
15 years |
0.9–2.7 nmol/L |
|
15–49 years |
9.2–55.8 nmol/L |
|
|
50+ years |
6.3–26.5 nmol/L |
|
Cardiovascular Risk – Apolipoprotein A1, Apolipoprotein B, Lipoprotein(a) with Lp-PLA2 (PLAC) test
The Lipoprotein(a) test measures the level of lipoprotein(a) in blood. High levels of lipoprotein(a) are indicative of higher risk for heart disease and stroke.
The two main groups of lipoproteins are HDL (high-density lipoprotein) (‘good’ cholesterol) and LDL (low-density lipoprotein) (‘bad’ cholesterol). Lipoprotein(a) is a type of LDL. High levels of LDL particles can create plaque – with associated risks of coronary or peripheral artery disease, narrow or blocked arteries, heart attack, stroke, other blood vessel disease.
Testing for lipoprotein(a) may provide a more accurate understanding of risk than a routine cholesterol or lipid profile that measures total LDL cholesterol level only. A raised lipoprotein(a) level may indicate a higher risk for heart and blood vessel disease, even if cholesterol levels are normal. Lipoprotein(a) levels usually change little over time – and genes control levels of lipoprotein(a). By the age of 5 years one’s lipoprotein(a) levels have been achieved and this tends to remain about the same for the rest of life. For that reason, repeat testing is not considered to be helpful, and diet and exercise may not change a person’s lipoprotein(a) levels. If the level is known to be high, it becomes all the more important to manage patients in an attempt to improve heart health.
|
Test |
Code |
Sample Reqs |
TAT |
|---|---|---|---|
|
Lipoprotein(a) |
LPOA |
1 x SST |
1 day |
ApoA1 and ApoB might be additionally used alongside other routine lipid tests to help determine an individual’s risk of developing CVD – rather than as a general population screen but better positioned where patients have a family history of heart disease and/or hyperlipidaemia to help determine the cause (especially in situations in which the LDL cholesterol cannot be calculated).
Levels of Lipoprotein(a), ApoA1, ApoB and ApoA/ApoB ratio are independent cardiovascular risk factors and using these results in clinical practice may provide more accurate markers of myocardial infarction risk.
|
Test |
Code |
Sample Reqs |
TAT |
|---|---|---|---|
|
Apolipoprotein A1 |
APOA |
1 x SST |
3 days |
|
Apolipoprotein B (includes ApoA/ApoB Ratio) |
APOB |
1 x SST |
3 days |
The Lp-PLA2 (PLAC) test measures Lp-PLA2 activity quantitatively. This assists with the prediction of risk caused by the thickening, or hardening, of the arteries caused by the build-up of plaque.
Both the methodology and reagent manufacturer changed for this test in mid-February, with resultant changes to reporting ranges, and units of measurement. The new reporting ranges are as follows:
- Reduced risk < 225 nmol/min/ml
- Increased risk = or > 225 nmol/min/ml
|
Test |
Code |
Sample Reqs |
TAT |
|---|---|---|---|
|
Lp-PLA2 (PLAC) Test |
PLA2 |
1 x SST |
2 days |
|
Cardiovascular Risk Profile 1 |
DL10 |
2 x SST |
3 days |
Discontinued tests
Laboratory tests may be discontinued at short notice for a variety of reasons such as changes with reagent manufacturers, analyser development, supply chain, suspension or regulatory review.
Depending on the reason, tests may be discontinued for the short or long term, or even permanently, and sometimes with very little notice. Whilst every effort is made to look for a comparable alternative accredited service this is not always possible.
Where an alternative is available, the turnaround times, normal values and methodology may be different. When there is no suitable alternative, the laboratory will notify as it may not be possible to store samples for the long term and it may be necessary to discard them or return them to the referrer.