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Chinese Researchers Develop Non-Invasive Clinical Laboratory Skin Test for Measuring Cholesterol

Study also may have found relationship between atherosclerosis and cholesterol

Chinese scientists have developed a cutting-edge method for non-invasively monitoring blood cholesterol levels in humans. The innovative technology utilizes images of skin on hands and may eliminate the need for both invasive venipunctures and fasting for testing cholesterol. Given the large volumes of blood cholesterol tests currently performed by clinical laboratories, this new technology could have significant impact on cholesterol testing if further studies confirm its capabilities.

Notably, the Chinese researchers have apparently already developed a lab analyzer to perform the procedure and it is being used in clinical care. However, in the United States and other countries, this technology will require additional clinical studies and regulatory review before clinical laboratories would be able to use it in daily patient care.

The cholesterol sensing system consists of a detection reagent associated with a fluorescent group that binds to skin cholesterol, and a detection device. Cholesterol levels are easily obtained from the skin, according to the researchers, by analyzing the manner in which the skin absorbs and scatters light via a scanner.

Should this technology be validated for clinical care, it could replace other invasive clinical laboratory tests for cholesterol measurement.

The scientists published their findings in the journal Lipids in Health and Disease, titled, “Non-invasive Skin Cholesterol Testing: A Potential Proxy for LDL-C and ApoB Serum Measurements.”

Demonstration of how non-invasive cholesterol test is performed

The series of images above, taken from the researchers’ Lipids in Health and Disease published study, demonstrates how their non-invasive clinical laboratory test for total blood cholesterol is performed. Non-invasive clinical laboratory tests for monitoring biomarkers in the blood are always preferred by patients over veinous punctures and fasting. (Photo copyright: Hefei Institutes of Physical Science, Chinese Academy of Sciences.)

First Evidence of Relationship between Cholesterol and Atherosclerosis

“Just put your hands on, and the system will tell you the cholesterol data,” Yikun Wang, PhD, Professor, Department of Physical Sciences, Hefei Institutes of Physical Science, Chinese Academy of Sciences, and leader of the research team, told Diagnostics World. “Cholesterol is one of several types of fats (lipids) that play an important role in human body, we can track your fats in this simple way.”

To perform the testing, clinicians first clean the test site located on the fleshy edge of the palm of the hand with an alcohol swab. A patient’s non-dominant hand is used for the test as the skin on that hand is typically less abrasive and contains fewer melanocytes, which allows for more stable results. A plastic-coated annulus is then applied to the test site and the examined portion is positioned on the measuring hole of the detection system to measure the background light spectrum of the skin.

Once the background signal is ascertained, the detection reagent is added to the annulus until it is full. After 60 seconds, any excess detection reagent is removed from the annulus. A cleaning reagent is then added to the annulus for 30 seconds and removed with a sterile cotton swab. The treated portion of the skin is then placed over the measuring hole of the detection system and two spectrums of light are compared to measure the skin cholesterol, which accurately correlates to the cholesterol in the bloodstream.

“Compared to in-situ detection used in the previous clinical research, our device may offer more accurate results for we can avoid the influence of pressure and skin background differences [person to person],” Wang said. “Study results offer the first evidence of a relationship between skin cholesterol and atherosclerotic disease in a Chinese population, which may be of great significance to researchers around the world.”

Initially, 154 patients diagnosed with acute coronary syndrome (ACS) between January 2020 and April 2021 were involved in the study. However, only 121 of those patients were included in the final study with the remaining being excluded due to at least one of the following criteria:

  • History of statin drug use,
  • Inability to tolerate statins,
  • Severe hepatic (liver) or renal (kidney) insufficiency, and
  • Obesity.

Clinician Use Can Affect Accuracy of Test

Developed by researchers from the Hefei Institutes of Physical Science Chinese Academy of Sciences, and the University of Science and Technology of China, the researchers noted that how clinicians operate the device can have an impact on the accuracy of the test results.

“A critical step in the [testing] process that is subject to operator variability is blotting, which requires the operator to remove an unbound detector from the palm before adding the indicator,” Wang told Diagnostics World. “Excess residual indicator solution can result in falsely increased skin cholesterol levels. Considering this, we are planning to develop a simplified and standardized blotting procedure.”

Millions of people in the US live with illness that requires regular monitoring of blood cholesterol. Normal total cholesterol should be less than 200 milligrams per deciliter (mg/dL). According to the federal Centers for Disease Control and Prevention (CDC), nearly 94 million US adults over the age of 20 have total cholesterol levels higher than 200 mg/dL and 28 million adults have total cholesterol levels higher than 240 mg/dL. In addition, 7% of children and adolescents between the ages of six and 19 have high cholesterol. For these reasons, cholesterol testing represents a substantial portion of the clinical laboratory tests performed daily in this country.  

This new non-invasive technology for monitoring total blood cholesterol in humans could greatly benefit patients, especially if it eliminates the need for venipunctures and fasting prior to testing. Clinical laboratory managers and pathologists may want to follow the progress of this new cholesterol testing technology as it demonstrates its value in China and is submitted for regulatory review in this country.

JP Schlingman

Related Information:

Non-invasive Scanning Tech Reads Blood Cholesterol Levels via the Skin

Non-invasive Skin Cholesterol Testing: A Potential Proxy for LDL-C and ApoB Serum Measurements

Researchers Develop Novel System for Rapid and Non-invasive Detection of Skin Cholesterol

Noninvasive Detection System to Prevent Cardiovascular Diseases

Skin Cholesterol Testing Could Play Role in Lipid Screening and Management

CDC: High Cholesterol Facts

For Medical Laboratory Tests, PIVO Enables Healthcare Practitioners to Obtain Blood Samples from Hospital Patients without a Needle Stick

Because patient satisfaction continues to drive Medicare scoring, interest grows in technologies that reduce or remove pain from the patient’s experience, particularly when a phlebotomist draws blood for clinical laboratory testing

Clinical laboratories know full well that patients do not like being stuck by needles. And hospital administrators know that increasing the hospital’s patient-satisfaction scores is important for Medicare hospital accreditation.

This is why hospital administrators are devoting more attention—and budget dollars—to products that have the potential to reduce the pain experienced by patients. And patient satisfaction surveys regularly identify pain during phlebotomy procedures as an issue.

Enter PIVO, a sterile single-use device created by San Francisco-based Velano Vascular Technologies that attaches to an existing peripheral intravenous (PIV) line to extract blood samples from patients through the use of a vacuum tube or syringe, relieving the pain of additional needle sticks.

Needle-free blood draws is not a new concept. But the fact that hospitals are adopting such technologies indicates that the need to improve the patient experience is motivating more hospitals to spend money on these types of devices.

Velano Vascular’s PIVO device (above) works by pushing a small, flexible flow tube through the IV line and directly into the vein to collect as much blood as needed for medical laboratory testing. After the blood collection has been completed, PIVO is retracted and removed from the IV and discarded. As public demand for pain free healthcare increases, will the practice of phlebotomy in all healthcare settings need to adopt as well? (Photo copyright: HIT Consultant.)

Nurses Approve of No-Stick Technology

The Centura Health system in Centennial, Colo., utilizes PIVO at all 17 of its hospitals throughout Colorado and western Kansas. Centura’s goal is to “eliminate some of the suffering that goes along with needlesticks for inpatients,” Rhonda Ward, MSN, Vice President Nursing Services and Chief Nursing Officer, South Denver Group, Centura Health, told Modern Healthcare.

“It adds no pain to the patient,” she said. “Unfortunately, nurses, just by nature of their work, have to create discomfort in some of the things that they have to do. So not creating more pain for the patient has been a big satisfier.”

Velano Vascular first gained FDA marketing clearance for its proprietary intravenous blood-draw device in 2015. Later that same year, Intermountain Healthcare in Salt Lake City became the first healthcare system in the country to implement the PIVO device. Intermountain now uses PIVO in all 22 of its hospitals.

“Blood draws are critical, common elements in modern medicine, but they cause an unnecessary amount of anxiety, pain and risk due to the use of century-old technology and practice,” said Kim Henrichsen, MSN, Senior Vice President, Clinical Operations/Chief Nursing Executive, Intermountain Healthcare, in a press release. “We are thrilled to offer a new standard of care that, over time, will help obviate the need for needles used for hospital blood collection. This commitment to standardizing draws will enhance quality for both patients and practitioners.” 

According to the Velano website, there are 400 million inpatient blood draws in the US each year, with each patient receiving 10 to 20 needlesticks per hospital stay. The site also states there are more than 1,000 practitioner needlestick injuries per day in the US and that approximately one in five people in the country are needle phobic. The company claims the advantages of the PIVO device include reducing patient pain and anxiety, making blood draws easier for Difficult Venous Access (DVA) patients, and making the blood extraction process safer for practitioners.  

“It is baffling that in an era of smartphones and space travel, clinicians draw blood by penetrating a vein with a needle—oftentimes in the early morning hours,” said Todd Dunn, Director of Innovation at Intermountain Healthcare Transformation Lab in the Intermountain press release. “Through our Design for People program, we resolved to find a better way for our phlebotomists and nurses to more humanely and consistently draw blood. Following 15,000 PIVO draws on adults and children with no adverse events and overwhelmingly positive feedback from patients and caregivers alike, it is clear that we are together establishing a new standard of care.”

According to a survey commission by Velano Vascular and conducted by Charter Oak Research of more than 6,500 nurses from 24 hospitals regarding the blood collection process:

  • Eight out of ten nurses are concerned about needle safety.
  • One in three patients are considered tough sticks.
  • 88% of the nurses felt that blood collection sticks and re-sticks negatively impact the patient experience.
  • 76% of the nurses would prefer to use needle-free blood draws over venipuncture.
  • 84% of the nurses said they would advocate for a needle-free blood draw device.

One of the key findings in the survey found that there is a lack of standardization in blood collection, and that there is “significant variability in who and how blood is collected across patient floors and time of day.”

“Commercial demand for PIVO and our family of novel solutions is being driven by a move to one-stick hospitalization and a growing realization that removing needles from blood draws improves the patient experience, protects practitioners, and boosts the bottom line,” Eric Stone, Chief Executive Officer and co-founder, Velano Vascular, told FierceBiotech.

More Research versus Patient Outcomes

Though there are peer-reviewed studies and white papers outlining positive patient outcomes surrounding the use of the PIVO device, some professionals feel more research on the product is needed.

“All of these studies would suggest that additional study would be warranted,” Diane Robertson, Director Health Technology Assessment and ECRIgene Information Services at the ECRI Institute, told Modern Healthcare. “But while the evidence is inconclusive at this point on a number of the potential benefits, in studies and in our look at safety information, there’s been no indication that there’s been any harm from this technology. It’s reasonable for hospitals to consider it. It goes back to weighing the patient-oriented outcomes.”

The need to improve the patient experience and improve patient satisfaction scores is motivating hospital administrators to spend money and resources on products like the PIVO device. Clinical laboratory leaders should be aware of the rate of adoption of such products by healthcare systems.

Continued growth in products that can collect medical laboratory specimens without a traditional venipuncture performed by a phlebotomist could give innovative labs a new way to add value in patient care in both inpatient and outpatient settings.

—JP Schlingman

Related Information:

Centura Health Cuts 30,000 Needles with New Blood-draw Program

What Do Nurses Think About Blood Collection?

A Novel Needle-Free Blood Draw Device for Sample Collection from Short Peripheral Catheters

Centura Health Joins Innovative Movement for One-Stick Hospitalization

Intermountain Healthcare First System in Nation to Remove the Needle from Blood Draws

Velano Taps $25M in New Funding for its Needle-free, Bedside Blood Draw System

University Hospitals Adopts Needle-Free Blood Draw Technology

Innovations in Microsampling Blood Technology Mean More Patients Can Have Blood Tests at Home, and Clinical Laboratories May Advance Toward Precision Medicine Goals

Clinical laboratory leaders aiming for patient-centered care and precision medicine outcomes need to acknowledge that patients do not want to be in hospitals or travel to physician offices and patient care centers for blood tests. It can be inconvenient, sometimes costly, and often painful.

That’s why disease management methods such as remote patient monitoring are appealing to many people. It’s a big market estimated to reach $1 billion by 2020, according to a Transparency Market Research Report. The study also associated popularity of devices such as heart rate and respiratory rate monitors with economic pressures of unnecessary hospital readmissions.

But can remote patient monitoring be used for more than to check heart rates, monitor blood glucose, and track activity levels? Could such technology be effectively leveraged by medical laboratories for remote blood sampling?

Microsampling versus Dried Blood Collecting

Remote patient monitoring must be able to address a large number of diseases and chronic health conditions for it to continue to expand and gain acceptance as a viable way to care for patients in different settings outside of hospitals. However, as most clinical pathologists and laboratory scientists know, clinical laboratory testing has an essential role in patient monitoring. Thus, there is the need for a way to collect blood and other relevant samples from patients in these remote settings.

One promising approach is the development of new microsampling technology that can overcome past obstacles of dried blood collection. Furthermore, microsampling-enabled devices can make it possible for medical laboratories to reach out to the homebound to secure accurate and volumetrically appropriate samples in a cost-effective manner.

“One well-established fact in today’s healthcare system is that an ever-greater proportion of patients want clinical care that is less invasive and less intrusive,” noted Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “Patients want to take more control over their treatment and be more effective at maintaining the stability of their chronic conditions, and often are happier than those who need to travel to have chronic conditions monitored. To meet this need there has been significant innovation, particularly in the area of remote blood sampling using microsampling technology.”

For decades, medical laboratories have tried various methods for acquiring and transporting blood samples from remote locations. One such non-invasive alternative to venipuncture is called dried blood spot (DBS) collecting. It involves placing a fingerprick of blood on filter paper and allowing it to dry prior to transport to the lab.

But DBS collected bio samples often do not contain enough hematocrit (volume percentage of red blood cells) for laboratories and clinical pathologists to provide accurate reports and interpretations. Reported reasons DBS cards have not penetrated a wide market include:

  • Hematocrit bias or effect;
  • Costly card punching and automation equipment; and,
  • Possible disruption to existing lab workflows.

Microsampling Technology Enables Collection of Appropriate Samples

Microsampling has to have the capability to enable labs to deliver quality results from reliable blood samples. This remote sampling technology makes it possible for phlebotomists to offer a comfortable collection alternative for homebound patients and rural residents. It also can be useful for physicians stationed in remote areas. Patients themselves can even collect their own blood samples.

Volumetric Absorptive Microsampling (VAMS) technology enables accurate samples of blood or other fluids from amounts as small as 10, 20, or 30 microliters, according to Neoteryx, LLC, of Torrance, Calif., the developer of VAMS. The technology is integrated into the company’s Mitra microsampler blood collection devices (shown above) in formats for patient use and for medical laboratory microsample accessioning and extraction. Click here to watch a video on the Mitra Microsampler Specimen Collection Device. (Photo copyright: Neoteryx.)

One company developing these types of products is Neoteryx, LLC, of Torrance, Calif. It develops, manufactures, and distributes microsampling products. Patients with the company’s Mitra device use a lancet to puncture their skin and draw a small amount of blood, collect it on the device’s absorptive tip, and then mail the samples to a blood lab for testing (Neoteryx does not perform testing).


“Technologies such VAMS are driving [precision medicine] in an extremely cost-effective manner, while only requiring minimal patient effort. Patients are taking a more active role in their healthcare journeys, and at-home sampling is supporting this shift,” stated Fasha Mahjoor, Chief Executive Officer, Neoteryx, in a blog post. (Photo copyright: Neoteryx.)

Advantages of Microsampling

Patient satisfaction survey data collected by Neoteryx suggest patients are comfortable with their role in blood collection:

  • 70% are comfortable or very comfortable with the process;
  • 86% say it is easy or very easy to use the Mitra device;
  • 92% report it is easy to capture blood on the device’s tip;
  • 55% of Mitra device users are likely or very likely to choose microsampling over traditional venipuncture; and,
  • 93% noted they are likely or very likely to choose the device for child care.

A list of published studies describes certain advantages of VAMS technology that have implications for medical laboratories and clinical pathologists:

  • Microsampling has benefits and implications for therapeutic drug monitoring, infectious disease research, and remote specimen collection;
  • Dried blood microsamples from fingerstick can generate reliable data “correlating” to traditional blood collection processes;
  • Bioanalytical data collected with the Mitra device are accurate and dependable; and,
  • In a study for a panel of anti-epileptic drugs, VAMS led to optimized extraction efficiency above 86%, which means there was no hematocrit bias.

Learn More by Requesting the Dark Daily Microsampling White Paper

To help medical laboratories and clinical pathologists learn more about microsampling and VAMS devices, Dark Daily and The Dark Report have produced a white paper titled “How to Create a Patient-Centered Lab with Breakthrough Blood Collection Technology: Microsampling Takes Blood Collection Out of the Clinic.” The paper includes sections addressing these topics:

  • Rise of patient-centered care and remote patient monitoring;
  • Dried blood collection over the years and the hematocrit effect;
  • A look at microsampling and how it takes blood collection out of the clinic;
  • How Volumetric Absorptive Microsampling (VAMS) technology works;
  • Patient satisfaction data;
  • Research about microsampling including extensive graphics;
  • Launching new VAMS technology; and,
  • Frequently asked questions.


Innovative medical laboratory leaders who want to increase their understanding of how microsampling technology and remote patient monitoring relates to the goal of becoming a patient-centered lab are encouraged to request a copy of the white paper. It can be downloaded at no cost by clicking here, or placing into your browser.

—Donna Marie Pocius

Related Information:

Remote Patient Monitoring Devices Market

Neoteryx, LLC, and Cedars Sinai Partner to Investigate at Home Blood Sampling Possibilities for Patients with Inflammatory Bowel Disease

Creating a Patient-Centered Lab with Breakthrough Blood Collection Technology Using New Microsampling Methods Provides Reliable, Economic Collection, Shipping and Storage Solutions

How to Create a Patient-Centered Lab with Breakthrough Blood Collection Technology: Microscopy Takes Blood Collection Out of the Clinic


Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry

Honors highlight concern among public and press over potential harm to patients of the medical laboratory industry and the need for more transparency in the quality of care delivered by pathologists and lab scientists

John Carreyrou, Investigative Reporter, and Mike Siconolfi, Senior Editor, both with The Wall Street Journal (WSJ), took home the prestigious National Institute for Health Care Management (NIHCM) Foundation Journalism Award on Monday, May 2, for their work covering Theranos, Inc.

This is the third time this year Carreyrou has won the award in the General Circulation Print Journalism category for his work covering Theranos, the embattled clinical laboratory company in Palo Alto, Calif., owned by CEO Elizabeth Holmes.


Internationally-respected Experts in Clinical Pathology and Laboratory Medicine Ask: Why Don’t We Know More about Theranos’ Technology?

This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology

Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.

One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.

The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility. (more…)