Is a rapid strep test a CLIA waived test?
Asked by: Makayla Davis | Last update: September 29, 2025Score: 4.4/5 (23 votes)
Is rapid strep test CLIA-waived?
Cardinal Health™ Strep A Rapid Tests are CLIA-waived rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
Which test is a CLIA-waived test?
By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.
What is the CLIA approved lab code for strep test?
If you have a physician office lab with this level CLIA license, you can use 87880 if you use the BioStar Optimal ImmunoAssay; if you dont have this level CLIA license you cant use 87880or even the test; and if you do have this level CLIA license but you use a waived strep test, you cant use 87880, but instead must use ...
Which type of test is the rapid strep test?
The rapid strep test (RST) is a rapid antigen detection test (RADT) that is widely used in clinics to assist in the diagnosis of bacterial pharyngitis caused by group A streptococci (GAS), sometimes termed strep throat.
Perform a CLIA Waived Microbiology Test Perform a Rapid Strep Test
How reliable is a rapid strep test?
On average, rapid tests for strep throat had a sensitivity (ability to correctly detect people with the disease) of 86% and a specificity (ability to correctly identify people who do not have the disease) of 95%.
How to bill a CLIA waived test?
CLIA waived tests requiring Modifier QW are considered simplified analysis tests. The QW modifier is used to identify waived tests and must be submitted in the first modifier field. CLIA requires all laboratory testing sites to have a current certification to legally perform clinical laboratory testing.
Does a strep test need a QW modifier?
CLIA-waived strep test
When billing Medicare for a CLIA-waived test, you will also need to add modifier -QW, “CLIA-waived test,” to the CPT code (e.g., 87880-QW).
Which of the following is not a CLIA waived test?
However, the ABG (Arterial Blood Gas) test is not a CLIA-waived test. It requires more complex procedures and is typically performed in a laboratory setting by trained professionals.
Are CLIA waived tests FDA approved?
Waived testing
They include: Certain tests listed in the CLIA regulations. Tests cleared by the FDA for home use. Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met.
Is 87804 a CLIA waived test?
Code 87804 describes the rapid flu test approved by the FDA requiring Clinical Laboratory Improvement Act (CLIA)-waived status. Use this code for detection by visual identification.
What is rapid test for Streptococcus A?
A rapid strep test involves a quick throat swab. Within minutes, the test can detect group A streptococcus bacteria, which can cause strep throat and other infections (including scarlet fever, abscesses, and pneumonia).
Can a rapid strep test be inconclusive?
If the results of the rapid strep test are inconclusive, then the pediatrician will do a throat culture. A throat culture requires the same kind of swab from the back of the patient's throat, which is then placed in a petri dish for a couple of days.
How much are rapid strep tests?
On MDsave, the cost of a Rapid Strep Test ranges from $11 to $197. Those on high deductible health plans or without insurance can shop, compare prices and save.
What tests are considered CLIA waived?
Historically, waived tests have included many point-of-care tests such as influenza tests, strep tests, and other simple tests. The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived.
What is an example of a waived test?
As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
What is the difference between a CLIA license and a waiver?
A CLIA waiver is for facilities performing waived tests, which are simple and low-risk. A CLIA certification is required for facilities conducting more advanced testing, such as: Moderate-complexity tests (e.g., automated CBCs or certain blood analyzers). High-complexity tests (e.g., PCR tests or genetic testing).
What is required prior to performing a CLIA waived test?
Before testing patient samples, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only one or more waived tests must file a Certificate of Waiver application and obtain a separate certificate for each location.
What is a commonly used CLIA waived test used to identify abnormal substances in the urine?
The Clinical Laboratory Improvement Amendments (CLIA) regulate medical testing, and dipstick urinalysis can be performed in a physician's office by obtaining a CLIA certificate of waiver.
How do I update my CLIA Waiver?
Basic changes such as address, phone, fax, contact person, email, laboratory name (without ownership change), certificate corrections, and laboratory closure, require these forms: LAB 193 (PDF) - Notification of Laboratory Change. CMS 116 (PDF) - to update CLIA certificate.
What is a rapid strep test called?
Other names: strep throat test, throat culture, group A Streptococcus (GAS) throat culture, rapid strep test, Streptococcus pyogenes.
How sensitive is the rapid strep test?
However, the sensitivity of most current rapid strep tests ranges from 90 percent to 95 percent, so there is a greater chance of false negatives. There have been few studies to show whether these patients with false-negative rapid strep tests are actually infected.
How do you do a rapid strep test?
In the test procedure, a throat swab specimen is collected, placed into a mixture of Reagent A and B, and extracted for 1–2 minutes. The Cardinal Health™ Strep A Dipstick Rapid Test strip is then inserted into the tube containing the extract and the extract is allowed to migrate up the test strip.