In Production: Quick and Cheap Bedside Test for Cortisol Uses Smartphone

An innovative method of measuring the stress hormone cortisol is being developed by researchers in Utah. Requiring just a simple kit and a smartphone to read results, this new approach should allow quick, affordable, and accurate testing of cortisol levels, enabling rapid diagnosis of adrenal diseases, the investigators say.

“A lab charges about $25 to $50 for a quantitative salivary cortisol test and has a turnaround time of days to a week,” said lead researcher Joel Ehrenkranz, MD, director of diabetes and endocrinology at Intermountain Medical Center, Murray, Utah. “This test, taken in a medical office or at home, will cost less than $5 and take less than 10 minutes,” he noted.

Dr. Ehrenkranz reported the details of the new test kit, developed at his institution, at ICE/ENDO 2014 week. He said he and his fellow researchers are now collating clinical data for a Food and Drug Administration (FDA) submission and hope to gain approval of the test as a class 2 medical device in the United States in 2015.

Chair of the session, Jeremy Tomlinson, MD, of University of Birmingham, United Kingdom, said the new approach employs “great technology and is an interesting innovation, but there are a few concerns. For example, how well will it perform against the state-of-the-art technique for measuring salivary cortisol, which is mass spectrometry — is it as sensitive?”

Also there is a possibility the immunoassay in the new test will cross react with another steroid hormone, prednisolone, that people might be taking for a whole range of inflammatory conditions, so “you would want to make sure it’s measuring what you want it to,” he noted.

And finally, there is the question of exactly how this would be used.

Cortisol levels are needed when conditions are suspected where too much or too little cortisol is produced, but the diagnosis for most of these doesn’t really need to be immediate, Dr. Tomlinson explained to Medscape Medical News. However, he conceded there might be a role for the assay in patients presenting to the emergency room or in developing nations.

No More Presumptive Treatment of Adrenal Insufficiency

At the meeting, Dr. Ehrenkranz said that adrenal diseases are commonly overlooked because current methods of measuring salivary cortisol require instrumentation and technical personnel and so are costly and unable to deliver timely results.

He noted also that a stint in the developing world convinced him that a simpler test was needed, so he and his colleagues set about developing an assay that would be inexpensive and easy to perform — they came up with disposable cortisol immunoassay strips containing a glass fiber element with colloidal gold-labeled murine anticortisol antibodies and a saliva collection pad.

The person being tested inserts a strawlike saliva collector under the tongue, which wicks the saliva to the immunoassay test strip housed in a cassette, which is then inserted into a reader in the device.

“The device…includes a case, a light pipe, and a lens and costs about a dollar to make. There is no battery power, and it’s unbreakable, passive, and reusable,” Dr Ehrenkranz said.

Because of the physical properties of the gold nanoparticles, a smartphone flash can illuminate and camera-image the color generated by the colloidal gold-labeled anticortisol antibodies, he explained.

The color subsequently generated is “read” by an app on the smartphone to give a cortisol reading, based on an algorithm derived from observed vs reference salivary cortisol values. The R value of this curve was 0.996 for salivary cortisol in the range of 0.012-3.0 µg/dL, Dr Ehrenkranz noted.

The new technology can therefore measure cortisol in a range sufficient to diagnose adrenal insufficiency and hypercortisolism and monitor physiologic variations in cortisol concentration, he said.

And the software is “operating-system agnostic,” he added, meaning the device can be used on all platforms, including iOS, Android, Windows, and BlackBerry, and it has a universal form factor that works with all smartphones.

“Measuring salivary cortisol at the point of care in 5 minutes using an inexpensive immunochromatographic assay, reader, and smartphone may obviate the need to presumptively treat patients for adrenal insufficiency and makes cortisol assays available to regions of the world that currently lack access to this diagnostic test,” he concluded.

Test of Use in Emergency Room, in Developing Countries

Dr. Tomlinson explained that diagnosis of Cushing’s syndrome — caused either by tumors of the pituitary gland producing too much ACTH or tumors of the adrenal gland producing too much cortisol — or alternatively, diagnosis of conditions where it’s thought too little cortisol is being secreted, such as Addison’s disease — an autoimmune process whereby the adrenal gland is destroyed — are not conditions “you necessarily have to diagnose in a few minutes by the bedside,” and therefore it is better to use the “gold standard” of diagnosis, mass spectrometry, in these cases.

But the new test “might be of use in determining whether people have enough of their own natural corticosteroid, in terms of deciding whether you need to give supplemental cortisol to people in an emergency situation,” he explained.

This could include patients presenting with suspected or underlying pituitary or adrenal disease or in people who have been on large doses of steroids who have then stopped taking them, so there will be a resulting suppression of their natural steroid production, he noted.

“That’s not an uncommon situation that we see in the emergency room. At the moment, if there’s suspicion, we might take a test but it takes a day or 2 to come back from the laboratory, and in the meantime we will give patients [presumptive] steroids. But you could do this test by the bedside,” he acknowledged.

And in developing countries, use of this test “is feasible, where cost comes into the equation and you might not have access to mass spectrometry; this could be an alternative and would help you to exclude or make these diagnoses,” he concluded.

This study was privately funded. Dr. Ehrenkranz and colleagues report no relevant financial relationships.

Joint Meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014; June 24, 2014. Abstract OR48-2

From http://www.medscape.com/viewarticle/827580

Hospital Staff Didn’t Give Emergency Cortisol to Teenager with Complex Special Needs

solu-cortef

 

A TEENAGER with complex special needs who died in hospital suffered a failure in basic medical communication, an inquest heard today.

Robin Brett, 18, of Blackmore Close, died in June 2014 in the Great Western Hospital after being admitted with chronic constipation and vomiting.

After a blood test indicated a raised white blood cell count, Robin went into cardiac arrest and died.

He had congenital adrenal hyperplasia (CAH) a metabolic disease and genetic defect of the adrenal gland and learning difficulties. He required daily care and medications.

Robin’s parents listed a string of errors they believe contributed to his death including failure to give him his regular medications, infrequent observations and the lack of regular and vital cortisol injections.

His heartbroken mother, Teresa, told the inquest in Salisbury that she had told hospital staff to give Robin an emergency dose of cortisol, which was not topped up after the recommended four hours.

She said: “I asked them to give him cortisol after I noticed he was becoming clammy and had a headache which is a sign of adrenal distress, I was just about to with the syringe in my hand when it was done and he instantly perked up.

 “But this wasn’t done again after four hours and I don’t know why.”

GWH staff nurse Hannah Porte who cared for Robin on his admission said she had concerns about his “alarmingly” high pulse rate when she did observations.

“I spoke with a doctor who assured me that because he had a pre-existing condition it wasn’t of great concern. That is our protocol and I felt comforted and reassured when they said that,” she said.

Robin was described as “rocking backwards and forwards and retching “ shortly before his cardiac arrest.

Mum Teresa broke down as she recalled her “sociable and friendly” son’s decline.

“He asked me to turn his DVD player off which was out of character in itself and he was clammy. All of a sudden he wasn’t breathing,” she said,

Registrar Fahreyer Alam, who examined Robin upon admission, said he could not provide an explanation as to why steroidal drugs were prescribed but not administered to Robin.

“They was nothing about his condition on examination which would link to adrenal crisis,” he said,

“The drugs were written on the drug chart and I cannot say why they were not given to him.”

Dr Alam said he had set an observation schedule of every two hours which he had articulated to nurses, and was not observed.

“All I can is there is an element of trust in the nurses and in a busy department we do have to relay things verbally and that is what you do,” he said.

When questioned by assistant coroner Dr Claire Balysz, Dr Alam said the effect of the seven week constipation may have put pressure on Robin’s vital organs.

“His heart and lungs were smaller than average and slightly underdeveloped. The faecal impaction made his colon stretch, it may have impacted his lungs and his heart and that is something the post mortem found,” he said.

Dr Alam and nurse Porte agreed that more was being done within the trust to improve the accuracy and accessibility of patient records, including a new observation system and the use of electronic prescribing and administration (EPMA) system.

Adapted from http://www.thisiswiltshire.co.uk/news/13843924.Robin_Brett__18__died_in_GWH_after_medics_failed_to_communicate__inquest_hears/

7 health conditions that are responsible for making you fat

Cushing’s syndrome: Cushing’s syndrome or hypercortisolism is a condition caused when the adrenal glands produce too much cortisol. This leads to a buildup of fat in the face, upper back and abdomen. Cushing’s syndrome can also be a side-effect of certain medications.

Read the other 6 at 7 health conditions that are responsible for making you fat | Read Health Articles & Blogs at TheHealthSite.com.

Adrenal insufficiency – how to spot this rare disease and how to treat it

adrenal-glandsAddison’s disease, or adrenal insufficiency, is a rare hormonal disorder of the adrenal glands that affects around 8,400 people in the UK.

The adrenal glands are about the size of a pea and perched on top of the kidneys, and affect the body’s production of the hormones cortisol and sometimes aldosterone.

When someone suffers from adrenal insufficiency, those glands aren’t producing a sufficient amount of these hormones. This can have a detrimental effect on someone’s health and well-being. But because the symptoms are similar to a host of other conditions, Addison’s disease can prove tough to isolate.

What to look out for

According to advice provided by the NHS, the symptoms in the early stages of Addison’s disease, which affects both men and women, are gradual and easy to misread as they’re similar to many other conditions.

People can experience severe fatigue, muscle weakness, low moods, loss of appetite, unintentional weight loss, low blood pressure, nausea, vomiting and salt craving.

“Symptoms are often misread or ignored until a relatively minor infection leads to an abnormally long convalescence, which prompts an investigation,” says Professor Wiebke Arlt from the Centre for Endocrinology, Diabetes & Metabolism at the University of Birmingham.

Life-threatening condition

If Addison’s disease is left untreated, the level of hormones produced by the adrenal gland will gradually decrease in the body. This will cause symptoms to get progressively worse and eventually lead to a potentially life-threatening situation called an adrenal, or Addisonian, crisis. Signs include severe dehydration; pale, cold, clammy skin; rapid, shallow breathing; extreme sleepiness; severe vomiting and diarrhoea. If left untreated, it can prove fatal, so the patient should be admitted to hospital as an emergency.

Back to basics

To understand the disorder, it’s important to get to grips with the basics and that means understanding what the adrenal glands are – and so to the science.

“Adrenal glands have an inner core (known as the medulla) surrounded by an outer shell (known as the cortex) ,” explains Arlt.
The inner medulla produces adrenaline, the ‘fight or flight’ stress hormone. While the absence of this does not cause the disease, the cortex is more critical.

“It produces the steroid hormones that are essential for life: cortisol and aldosterone,” he adds.

“Cortisol mobilises nutrients, enables the body to fight inflammation, stimulates the liver to produce blood sugar and also helps control the amount of water in the body. Aldosterone, meanwhile, regulates the salt and water levels, which can affect blood volume and pressure.”

Why does it happen?

The disorder occurs if the adrenal glands are destroyed, absent or unable to function and failure of the glands themselves is known as primary adrenal insufficiency.

“It’s most often caused by autoimmune disease where the body’s immune system mounts an attack against its own adrenal glands,” explains Arlt.

“However it can also be caused by infection, most importantly by tuberculosis and sometimes by both adrenal glands being surgically removed.”

The pituitary effect

Another important cause is any disease affecting the pituitary gland, which is located behind the nose at the bottom of the brain.
“The pituitary is the master gland that tells the other glands in the body what to do,” continues Arlt.

“The pituitary gland produces a hormone called ACTH (adrenocorticotropic hormone to give it its full name), which travels in the blood stream to the adrenal glands.

“Here it acts as a signal, causing the adrenal glands to produce more cortisol. If the pituitary gland stops making ACTH, [then] cortisol production by the adrenals is no longer controlled properly and a condition called secondary adrenal insufficiency arises.”

But in most cases, aldosterone is still produced, which means that people suffering from secondary adrenal insufficiency have fewer problems than those with primary adrenal insufficiency.

Determining a diagnosis

Due to the ambiguous nature of the symptoms, a Short Synacthen Test (SST) needs to be performed in order to diagnose adrenal insufficiency.

“This measures the ability of the adrenal glands to produce cortisol in response to (the pituitary hormone) ACTH,” says Arlt. “When carrying out this test, a baseline blood sample is drawn before injecting a dose of ACTH, followed by drawing a second blood sample 30 to 60 minutes later. Failing adrenal glands will not be able to produce a certain level of cortisol.”

Getting treatment

If someone has been conclusively diagnosed with adrenal insufficiency, they should receive adrenal hormone replacement therapy as advised by an endocrinologist, a doctor specialising in hormone-related diseases.

“A normal adrenal gland does not need supplements to function properly and there is no recognised medical condition called ‘adrenal fatigue’,” warns Arlt.

“Either the adrenal gland is fine and needs no treatment or there is adrenal insufficiency due to adrenal or pituitary failure.”

So if in doubt, don’t self-diagnose but book an appointment with your GP.

For more information, visit Addison’s Disease Self-Help Group (www.addisons.org.uk) or Pituitary Foundation.

From https://home.bt.com/lifestyle/wellbeing/adrenal-insufficiency-how-to-spot-this-rare-disease-and-how-to-treat-it-11363985141306

Common Asthma Steroids Linked to Side Effects in Adrenal Glands

(Reuters Health) – After stopping steroids commonly prescribed for asthma and allergies, a significant number of people may experience signs of malfunctioning in the adrenal glands, a European study finds.

So-called adrenal insufficiency can be dangerous, especially if the person’s body has to cope with a stress like surgery, injury or a serious illness, the study authors say.

“The takeaway message of the study is that in corticosteroid use there is a substantial risk of adrenal insufficiency,” senior author Dr. Olaf Dekkers, an endocrinologist at Aarhus University in Denmark, said by email. “Patients should be aware of this risk and be informed about potential symptoms.”

Those symptoms can include fatigue, dizziness, weight loss and salt cravings, the authors write in the Journal of Clinical Endocrinology and Metabolism.

Corticosteroids are man-made drugs designed to mimic the hormone cortisol, which the adrenal glands produce naturally. The drugs are usually used to counter inflammation in a wide range of conditions, including asthma, psoriasis, rheumatoid arthritis, lupus, blood cancers and organ transplants.

People with adrenal insufficiency do not make enough of two hormones, cortisol and aldosterone. Cortisol helps the body respond to stress, recover from infections and regulate blood pressure and metabolism. Aldosterone helps maintain the right amounts of salt, potassium and water in the body.

While on steroids, the body often produces less of these hormones naturally, and after coming off the drugs it can take a while for natural production to ramp back up. The result is adrenal insufficiency, which can be treated with medication to replace cortisol or aldosterone.

Dekkers and colleagues analyzed 74 research articles published from 1975 to 2014, covering a total of 3753 study participants, to see how different doses and types of corticosteroid treatment might impact the likelihood of developing adrenal insufficiency after treatment.

Researchers found the risk of adrenal insufficiency was highest when corticosteroids were taken orally or injected, and lower with inhaled, nasal or topical treatment.

When they looked just at patients using steroids for asthma, the researchers found that the risk of adrenal insufficiency was about 7 percent with inhaled corticosteroids, but about 44 percent with other formulations including oral medication.

Only about 2 percent of asthma patients on the lowest dose of steroids experienced adrenal insufficiency, compared with about 22 percent on the highest doses.

Similarly, slightly more than 1 percent of asthma patients on short-term steroids developed adrenal insufficiency, compared with about 27 percent on long-term treatment.

There is no way to safely halt treatment with corticosteroids that can rule out the potential for adrenal insufficiency, Dekkers said.

The side effect is more likely when patients take higher doses of steroids or remain on treatment for longer than three weeks, said Dr. Roberto Salvatori, medical director of the pituitary center at Johns Hopkins Hospital in Baltimore.

“It’s likely, and it’s often overlooked because most often the people who prescribe corticosteroids aren’t endocrinologists; they are in other specialities and they don’t recognize the symptoms of adrenal insufficiency,” said Salvatori, who wasn’t involved in the study.

He gives his patients on corticosteroids medical identification bracelets or necklaces to wear so they can be identified as at risk for adrenal insufficiency in an emergency. “This is a very important issue that’s not on the radar screen,” he said.

To be sure, more physicians are aware of the risk now than in the 1970s, and the standard doses and durations of corticosteroid treatment have been reduced in part because of this risk, said Dr. Douglas Coursin, a professor at the University of Wisconsin School of Medicine and Public Health in Madison. He, too, advises medical alert bracelets for patients on long-term or high-dose treatment.

“In the past, patients with asthma, certain immune diseases, those receiving some cancer therapies and those who had a solid organ transplant received higher doses for longer periods of time,” Coursin, who wasn’t involved in the study, said by email. “Overall, I think the risk may be lower than outlined in the study because of practice changes.”

SOURCE: bit.ly/1PjRHYw Journal of Clinical Endocrinology and Metabolism, online April 6, 2015.