What are the 4 main purposes of laboratory testing?
The different purposes for which laboratory tests are ordered (diagnosis, monitoring therapy, and screening) and the operating characteristics required for each purpose. The "normal" test result and its meaning.
Which of the following is an example of using a laboratory test to assist in the differential?
Which of the following is an example of using a laboratory test to assist in the DIFFERENTIAL diagnosis of a patient's condition? Performing a STREP test to determine if a patient has STREP THROAT or PHARYNGITIS.
What is the purpose of patient preparation for a laboratory test?
The purpose of patient preparation for a laboratory test is to ensure the test results fall within the reference range.
What are the indications of laboratory tests?
There are the following indications and significance for ordering any lab test are:To confirm the diagnosis of the disease. Some of these tests are confirmatory, and some suggest that disease. ... To help in the differential diagnosis: ... To know the prognosis: ... To monitor the treatment: ... As screening tests:
What are some examples of situations where a doctor might order a lab test to aid in the diagnosis and treatment of a patient?
We summarized these into five categories: (1) to exclude disease and reduce the physician's uncertainty, (2) to confirm diagnosis and to determine treatment, (3) to reassure patients and at patient's request, (4) monitoring of disease (screening for hypertension/cholesterol/diabetes and check-up for known disorder), ...
What are clinical laboratory tests?
Using laboratory equipment, the clinical laboratory scientist analyzes body fluid samples, such as blood, urine, or DNA samples. These results of these analyses provide information that helps physicians diagnose or monitor a patient's state of health or disease.
What are the factors that influences a laboratory test?
Factors that can affect laboratory investigationsX.Article Sections.Biological variation.Individual variations.Medicines.Analytical variation.
What patient preparation should be noted to allow the patient to proceed with her laboratory tests?
Other common test preparations include:Avoiding specific foods and drinks such as cooked meats, herbal tea, or alcohol.Making sure not to overeat the day before a test.Not smoking.Avoiding specific behaviors such as strenuous exercise or sexual activity.Avoiding certain medicines and/or supplements.
What are the most common pre testing preparations a provider can give a patient?
One of the more common types of preparation required for testing is fasting (to go without all or certain foods) for several hours before the test or even overnight. Certain tests may require you to increase or decrease the amount you drink for 10 to 12 hours prior to the test.
What is the importance of laboratory tests in the diagnosis of diseases?
Laboratory tests are particularly useful in validating a diagnosis, predicting disease severity, and monitoring disease progression in patients with infectious diseases or immunological disorders. Timely diagnostic assessment and implementation of reliable tests are extremely important in disease management.
Why does the government regulate clinical laboratories?
The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. CMS oversees all lab testing (except some research) done on humans in the U.S. through CLIA.
What is a LDT test?
Laboratory Developed Tests. A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), ...
When did LDTs become FDA approved?
Due to advances in technology and business models, LDTs have evolved and proliferated significantly since the FDA first obtained comprehensive authority to regulate all in vitro diagnostics as devices in 1976.
What are the problems with LDTs?
The FDA has identified problems with several high-risk LDTs including: claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death. The FDA is aware of faulty LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease.
Why is LDT important?
LDT’s are important to the continued development of personalized medicine, so it is important that in vitro diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay needed treatments, or become exposed to inappropriate therapies.
What can be used to diagnose genetic disease?
For example, some tests can detect many DNA variations from a single blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium. While the uses of an LDT are often the same as the uses ...
When did the FDA reconsider its enforcement discretion?
In 2010, the FDA announced its intent to reconsider its policy of enforcement discretion for LDTs and held a workshop to obtain input from stakeholders on such policy. FDA used this feedback to develop an initial draft approach for LDT oversight and published draft guidance in 2014.
Is a hospital lab a LDT?
For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market. The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them. LDT’s are important to the continued ...
What are the uses of laboratory results?
1) to assist in the diagnosis of pathologic conditions. 2) to evaluate the pt.'s progress and to regulate treatment. 3) to establish a baseline level. 4) to prevent or reduce the severity of disease. 5) to comply with state laws.
What is a test system?
test system. A setup that includes all of the test components required to perform a laboratory test such as testing devices, controls, and testing reagents. waived test. A laboratory test that meets the CLIA criteria for being a simple procedure that is easy to perform and has a low risk of erroneous test results.
What is plasma test?
A complex laboratory test that does not meet the CLIA criteria for waiver and is subject to the CLIA regulations. Plasma. liquid part of the blood, consisting of a clear, yellowish fluid that compromises appx. 55% of the total blood volume.
What is a profile test?
profile. array of laboratory tests for identifying a disease state or evaluating a particular organ or organ system. qualitative test. A test that indicates whether or not a substance is present in the specimen being tested and also provides an approximate indication of the amount of the substance present.
What is the role of a lab assistant?
assists the lab in correlating clinical lab data with the needs of the physician
What does the number of days mean in a lab?
indicates to the lab the number of days that have passed since the collection, providing the lab with information regarding the freshness of the specimen
What is a quantitative test?
Quantitative test. A test that indicates the exact amount of a chemical substance that is present in the body, with the results being reported in measurable units. Reagent. A substance that produces a reaction with a patient specimen that allows detection or measurement of the substance by the test system.
What is a laboratory test?
What are laboratory tests? A laboratory test is a procedure in which a sample of blood, urine, other bodily fluid, or tissue is examined to get information about a person’s health. Some laboratory tests provide precise and reliable information about specific health problems.
How does a laboratory test affect a person's health care?
The results of laboratory tests affect many of the decisions a doctor makes about a person’s health care, including whether additional tests are necessary, developing a treatment plan, or monitoring a person’s response to treatment .
How do I interpret my test results?
With some laboratory tests, the results obtained for healthy people can vary somewhat from person to person. Factors that can cause person-to-person variation in laboratory test results include a person's age, sex, race, medical history, and general health. In fact, the results obtained from a single person given the same test on different days can also vary. For these tests, therefore, the results are considered normal if they fall between certain lower and upper limits or values. This range of normal values is known as the " normal range ," the " reference range ," and the " reference interval ." When healthy people take such tests, it is expected that their results will fall within the normal range 95 percent of the time. (Five percent of the time, the results from healthy people will fall outside the normal range and will be marked as " abnormal .") Reference ranges are based on test results from large numbers of people who have been tested in the past.
What if a laboratory test result is unclear or inconclusive?
If a test result is unclear or inconclusive, the doctor will likely repeat the test to be certain of the result and may order additional tests. The doctor may also compare the latest test result to previous results, if available, to get a better idea of what is normal for that person.
What new laboratory tests for cancer medicine are on the horizon?
One circulating tumor cell test has been approved by the Food and Drug Administration (FDA) to monitor patients with breast, colorectal, or prostate cancer. However, such tests are still being studied in clinical trials and are not routinely used in clinical practice.
Why do doctors use other tests?
Other tests provide more general information that helps doctors identify or rule out possible health problems. Doctors often use other types of tests, such as imaging tests, in addition to laboratory tests to learn more about a person’s health.
What is the purpose of a cancer diagnosis?
To help diagnose cancer. To provide information about the stage of a cancer (that is, its severity); for malignant tumors, this includes the size and/or extent (reach) of the original (primary) tumor and whether or not the tumor has spread ( metastasized) to other parts of the body. To plan treatment.
