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Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
This assay is used for screening for HIV-1 and/or HIV-2 infection in asymptomatic patients, the diagnosis of HIV-1 and/or HIV-2 infection in symptomatic patients, and follow-up testing of individuals with reactive results from rapid HIV tests.
AIDS is caused by 2 known types of HIV. HIV type 1 (HIV-1) is found in patients with AIDS, AIDS-related complex, and asymptomatic infected individuals at high risk for AIDS. The virus is transmitted by sexual contact, by exposure to infected blood or blood products, or from an infected mother to her fetus or infant.
The standard of care test for diagnosing HIV in a clinical setting is the serum test, known as the HIV fourth-generation test, a combination antibody (Ab) and antigen (Ag) test. Before the US Centers for Disease Control and Prevention (CDC) recommendation in 2014 to use the fourth-generation test, only Ab tests were used. The fourth-generation test looks not only for antibodies formed against HIV-1 and HIV-2 but also for the p24 Ag, allowing for earlier detection of HIV after exposure. The p24 Ag is detectable as early as 14 days after exposure. If the Ag test is positive and Ab negative, a reflex RNA test will confirm or negate the test. If the Ag and Ab are positive, the test will confirm if the HIV Ab is present by differentiating between HIV-1 and HIV-2. The differentiation of HIV-1 and HIV-2 is also novel to the fourth generation test and was not available in previous generations of tests.
If a very early HIV infection (less than 14 days) is strongly suspected, an HIV RNA test should be performed initially to detect an infection that may be present before the p24 Ag can be detected. Depending on the sensitivity of the RNA assay, the RNA may be detected as early as 5 to 10 days after the transmission of HIV. RNA also should be performed if the fourth-generation test is indeterminate.
Statement on Medical Necessity
All ordered tests should be medically necessary for the diagnosis or detection of disease, illness, impairment, symptom, syndrome, or disorder and the results should be used in the medical management and treatment decisions for the patient. Solaris requires ICD-10 codes with each order for lab testing and both the tests ordered and the diagnosis should be documented in the provider’s medical record for the patient. The United States Department of Health and Human Services, Office of Inspector General, takes the position that a provider who orders medically unnecessary tests may be subject to civil penalties.
Panels and Profiles
Solaris offers Providers the convenience of ordering test combinations in a group at times with the flexibility to choose appropriate test(s) for individual patients. Providers should only order those tests that he or she believes are medically necessary for each patient, and a lesser inclusive profile or individual tests should be ordered if not all tests in the test combination/profile are medically necessary. All tests offered in a test combination/profile may be ordered separately as individual tests. Solaris encourages clients to contact their Solaris representative if the testing configurations shown do not meet individual needs for any reason, or if some other combination of procedures is needed.
CPT Codes
CPT Codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are the responsibility of the billing party and are listed here for informational purposes. Correct coding may vary from one carrier to another. Solaris may bill specific carriers using codes other than what is shown.
For questions or inquiries related to testing please reach out to
customerservice@solarisdx.com or contact us by phone at (844) 550-0308.
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