About the product
The Elecsys HIV Ag Confirmatory Test (Roche code CPS_000883) is an immunoassay used for the in vitro confirmation of the presence of HIV-p24 antigen in human serum and plasma samples. According to the Roche product page, the test is defined for samples that give a repeatedly reactive or borderline result on the Elecsys HIV Ag test and for samples that are reactive in the HIVAG module of the Elecsys HIV Duo test.
Measured parameter and clinical significance
HIV-p24 is one of the core proteins of HIV. According to the CDC MMWR publication, p24 antigen can be detected before antibodies form. For this reason, fourth-generation immunoassays that look for antigen and antibody together can identify some infections in the acute phase.
According to the algorithm described in the same publication, a reactive immunoassay result is followed by a supplemental test. When the supplemental test is negative, the sample is evaluated with an HIV-1 RNA test. If an RNA test cannot be performed, a repeat immunoassay after 2 to 4 weeks is recommended. The publication dates from 2013, and the current algorithm should be rechecked in CDC sources. The result of a confirmatory test is evaluated within the algorithm followed by the laboratory and together with other test results.
Technical information
- Product: Elecsys HIV Ag Confirmatory Test (Roche, CPS_000883)
- Intended use: in vitro confirmation of HIV-p24 antigen
- Sample: human serum and plasma
- Pack size: 1 × 2 set
- The method principle, sample volume, test time and measuring range are in the Roche method sheet
Use and compatibility
On the Roche product page, the sample groups for which the test is used and the systems are as follows:
- Samples giving a repeatedly reactive or borderline result on the Elecsys HIV Ag test
- Samples giving a reactive result in the HIVAG module of the Elecsys HIV Duo test
- Systems: cobas e 411, cobas e 601 and cobas e 602
System page: cobas e 411. Other immunoassay reagents are on the test kits page.
The testing algorithm and the reporting of results are the responsibility of the laboratory concerned and of national guidelines.
Frequently asked questions
According to the Roche product page, the test is used for the in vitro confirmation of the presence of HIV-p24 antigen in human serum and plasma samples.
According to the Roche product page, the test is defined for samples that are repeatedly reactive or borderline on the Elecsys HIV Ag test and samples that are reactive in the HIVAG module of the Elecsys HIV Duo test.
According to the CDC MMWR publication, p24 antigen can be detected before HIV antibodies, and fourth-generation immunoassays can identify some acute infections.
Contact
For product, quotation and technical information requests, use the contact form or write to info@tiliamedical.com.
