Medical consumers can take advantage of a wide variety of tests, such as checking cholesterol levels, determining cancer predisposition, DNA testing for paternity identification, etc. These tests, however, come at a price. With direct access testing (DAT), patients have the opportunity to take control of their health care. The potential is excellent, but as the industry grows, medical consumers should have a clear understanding of the benefits and drawbacks of DAT.
To learn more, check out the infographic below created by the University of Cincinnati’s online Bachelor of Science in Medical Laboratory Science degree program.
How Consumer Needs Impact DAT
Medical consumers are increasingly becoming more information-driven. As such, they are much more interested in being actively involved in their health care, hence putting more pressure on the direct access testing industry to ensure that their needs are met.
Understanding Direct Access Testing
According to the Centers for Medicare and Medicaid Services, DAT is the “testing of human specimens” as initiated by the consumer instead of the physician. DAT is sometimes called a service that is direct-to-consumer, patient-authorized, self-ordering or consumer-driven.
Kalorama Information estimates that DAT lab tests generated a revenue of $33.1 million in 2015. With its current popularity, the industry is expected to enjoy a projected annual growth of 30 percent in the next five years. Already, 35 percent of states in the U.S. allow direct access testing.
Most Popular Tests as Ordered by Medical Consumers
CBC with Differential
A complete blood count with differential is a routine blood test that measures levels of red blood cells, white blood cells, hemoglobin, hematocrit and platelets. It aids in the detection of anemia and infections.
Semen analysis, also called a sperm count test, is performed to analyze the viability and condition of sperm. It analyzes factors such as the number, shape and movement or motility of the sperm. A semen analysis is usually performed to determine if a man is fertile or not, or to check if sperm remain in the semen of a man who has undergone a vasectomy.
A lipid panel is a type of blood test that analyzes the quantity of fatty substances and lipids-fats. The test can measure levels of triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol.
HIV Antibody Status
HIV testing is a type of blood test that diagnoses and screens for HIV infections based on the presence of HIV antibodies in blood or body fluids.
An allergen-specific IgE test is a diagnostic test that determines the immune reaction of a patient to specific substances. This test is usually performed using a skin test or a serological test. In some cases, a direct challenge test is performed.
ABO/Rh Blood Typing
Blood typing aims to identify specific markers known as antigens in a patient’s blood. It is done to determine a person’s blood type. This test is useful for ensuring the right match for blood transfusion and for determining if two or more people are blood relatives.
Hepatic Function Panel
This test is performed to determine the condition of the liver. It tests for levels of albumin, liver enzymes, bilirubin and total protein.
Rapid Plasma Reagin
The RPR blood test is performed to screen a patient for syphilis. It helps detect nonspecific antibodies that indicate an infection.
Comprehensive Metabolic Panel
This test measures the level of glucose in the blood, determines electrolyte and fluid balance, and analyzes liver and kidney functions.
The TSH blood test is performed to check the condition of the thyroid gland and to identify any problems.
The PSA test measures the level of prostate-specific antigens in the blood. It helps determine prostate enlargement or prostate cancer.
Therapeutic Drug Monitoring
TDM is performed to measure the concentrations of medications or drugs in the blood. This is usually done for diagnostic purposes to reduce drug toxicity, enhance drug efficacy and aid with diagnosis.
Culture and Antibody Sensitivity
A culture test helps determine and identify infections caused by bacteria or fungi, while an antibody sensitivity test helps identify the type of drug that is the most effective in the treatment of an infection or disease.
DAT testing services are generally paid for directly by the patients, since most insurance companies do not provide reimbursement.
Factors That Drive the DAT Industry
- An aging population
- The increasing number of uninsured patients
- High cost of deductibles and copays
- Chronic disease monitoring
- Treatment monitoring
- An increasingly more informed public
- Internet making research information readily available
- Early detection of health-related issues
Benefits and Drawbacks of DAT
The capabilities offered by direct access testing provide a number of immediate and specific benefits to medical consumers. There are, however, certain limitations to consider.
- Patients have direct access to testing and results.
- Patients are involved directly in their health care.
- Collaboration between patient and physician is developed.
- Cost savings.
- Physicians are not completely in control when it comes to patient management.
- Consumers may not be capable of interpreting test results.
- Consumers may not have the same access to information regarding their medical and family history, and other relevant information that may affect the interpretation of tests.
- The price of tests may rise because of increased demand.
- Unscrupulous laboratories might take advantage of consumers’ health concerns through fear tactics.
- Medical consumers may develop hypochondria.
- Medical consumers may also feel a false sense of security or panic for results that may appear as normal or abnormal.
A Closer Look at Laboratory Regulations
The Clinical Laboratory Improvement Amendments (CLIA) ensure safe, consistent and accurate services offered by clinical laboratories. The FDA states that CLIA was established to improve oversight on the federal level regarding clinical laboratories and to ensure the reliability and accuracy of test results for patients. This is critical, particularly since tests are categorized based on complexity, from waived to moderate complexity to high complexity. Compliance with CLIA-set requirements will ensure that direct access testing will continue to provide reliable test results to consumers.
Advantages of DAT Conducted in Laboratories Regulated by CLIA
CLIA is supervised and regulated by three government agencies: the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Center for Medicaid Services (CMC). Another key advantage is that when test complexity is determined, it is easier to identify which CLIA requirements are applicable.
CLIA also provides standards for quality based on the complexity of tests in certain areas, such as facility administration; general laboratory systems; personnel qualifications and responsibilities; pre-analytic, analytic and post-analytic systems; proficiency testing; quality assessment; quality control; and specific cytology provisions.
What the Future Holds
The direct access testing industry is expected to expand, and the number of clinical laboratories operating under CLIA regulations will increase, providing patients who want to be more proactive and take control of their health options with more reliable and safer testing services. Physicians are also expected to take a more active role in interpreting tests and establishing a baseline for each patient’s medical history.