Is HIV Ag/Ab Combo Test Considered Fourth-Generation ELISA? - Internal Medicine

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Hello Dr.
Hong, thank you for your response during the holiday.
Currently, many testing facilities are using the HIV Ag/Ab Combo, which includes both antibody and antigen (p24) testing.
I would like to ask you, Dr.
Hong, is the HIV Ag/Ab Combo test considered the so-called fourth-generation ELISA? I apologize for the scattered nature of my questions, and I appreciate your time in helping me with this.
Thank you for your efforts.

JJ, 30~39 year old female. Ask Date: 2020/04/12

Dr. Hong Yuanbin reply Internal Medicine


Hello, the HIV Ag/Ab Combo test is indeed what is commonly referred to as the fourth-generation ELISA, which can simultaneously detect both antibodies and the p24 antigen.
Thank you for your inquiry.

Reply Date: 2020/04/12

More Info


The HIV Ag/Ab Combo test is indeed classified as a fourth-generation ELISA (Enzyme-Linked Immunosorbent Assay). This test is designed to detect both HIV antibodies and the p24 antigen, which is a protein produced by the virus. The inclusion of the p24 antigen allows for earlier detection of HIV infection compared to tests that only detect antibodies.
In the context of HIV testing, the evolution of testing methods has led to the development of different generations of tests. The first-generation tests primarily detected antibodies to HIV, while second-generation tests improved sensitivity and specificity. The third-generation tests further enhanced these features but still relied solely on antibody detection. The fourth-generation tests, such as the HIV Ag/Ab Combo, represent a significant advancement because they can identify the virus earlier by detecting the p24 antigen, which appears in the blood shortly after infection, typically within 2 to 4 weeks.

The ability to detect both the antigen and antibodies means that the fourth-generation tests can provide a more comprehensive assessment of HIV status. This is particularly important during the "window period," which is the time after infection when antibodies are not yet detectable. By identifying the p24 antigen, the test can yield positive results even when antibodies are still developing, thereby reducing the risk of false negatives.

Regarding the interpretation of test results, values below 1.0 are generally considered negative, indicating no evidence of HIV infection. Values above this threshold may suggest a positive result, warranting further testing or confirmation. It is also important to note that the HIV Ag/Ab Combo test is capable of detecting both HIV-1 and HIV-2, including various subtypes and groups, making it a versatile tool in HIV screening.

When comparing the terms "HIV Ag+Ab Combo" and "HIV Ag/Ab Combo," they refer to the same testing methodology. The difference in notation (using "+" versus "/") does not imply a difference in the test's functionality; it merely reflects different ways of presenting the information. Both formats indicate that the test is assessing for the presence of both the antigen and antibodies.

In terms of the terminology used in laboratories, "EIA" (Enzyme Immunoassay) is a broader category that encompasses various types of enzyme-linked immunoassays, including ELISA. While ELISA is one of the most common forms of EIA, the terms are often used interchangeably in practice. Therefore, when you see references to EIA or ELISA in the context of HIV testing, they typically refer to similar methodologies aimed at detecting HIV proteins.

In summary, the HIV Ag/Ab Combo test is a fourth-generation ELISA that enhances early detection of HIV by identifying both the p24 antigen and antibodies. It is crucial for individuals at risk of HIV infection to undergo regular testing, especially if they engage in high-risk behaviors. The advancements in testing technology have significantly improved our ability to diagnose HIV early, which is vital for effective treatment and reducing transmission rates.

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Hello Dr. Hong, I have undergone the fourth-generation ELISA HIV Ag/Ab combo test twice within a week. The first result was 0.09 and the second was 0.12. I would like to ask if this increase in values is normal, or if values below 1 are considered acceptable. Additionally, does t...


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