MAY 08, 2019 11:22 AM PDT

Fourth-Generation Rapid Diagnostic Tests for Acute HIV-1 Infections

WRITTEN BY: Dena Aruta

The ability to diagnose an acute HIV-1 infection before there are detectable antibodies to HIV 1/2 is critical to making an early diagnosis and getting the individual into treatment. Approximately 5-20% of all HIV infections come from recently infected patients making early detection a vital part of the control of an epidemic in a community or demographic area. Early detection through laboratory testing requires the presence of HIV antigen (HIV-1 p24 antigen) or nucleic acids in the blood. There are currently rapid fourth-generation point-of-care diagnostic tests approved for a variety of clinical settings that detect both antibodies to HIV 1/2 and  HIV-1 p24 antigenemia. However, the sensitivity (the ability of the test to identify a patient with the disease) for these tests varies ranging from 2-92%. J. M. Lewis and colleagues, concerned that such a wide range in sensitivity may result in substandard accuracy leading to false negatives/positives, performed a systematic review to evaluate the accuracy of these tests being used in the field. 

The inclusion criteria included studies that evaluated the "field performance of at least one fourth-generation RDT for acute HIV-1 in adults (aged>15 years)," and they allowed cross-sectional studies, cohort studies, and randomized control trials in the literature search. Out of the 2,056 studies, four met the criteria with a total of 17,381 participants. The index laboratory test evaluated in all four studies was the Alere Determine HIV-1/2 Ag/Ab Combo (Alere Medical Co.Ltd., Chiba, Japan), which is a fourth-generation rapid diagnostic test that detects both HIV 1/2 antibodies and the HIV-1 p24 antigen. 

The review revealed that the index test didn't accurately detect any true positive specimens for acute infection in the 17,381 participants, even though they were from high-risk areas including Sub-Saharan Africa, Australia, and the U.K. 26 known acute infections were missed and 35 false positives. "Based on these results and poor sensitivity of this test, we recommend that this test not be used for point-of-care testing for acute HIV-1 testing," stated Lewis. 

The authors concluded that fourth-generation tests are unreliable, and testing should be limited to third-generation tests, which detect HIV-1/2 antibodies only. This study was limited by evaluating only one test, but there are other kits available including: "SD Bioline HIV Ag/Ab (Standard Diagnostics, Inc., Giheung-gu, Republic of Korea) and ImmunoComb II HIV 1&2 TriSpot Ag-Ab (Orgenics Ltd, Yavne, Israel."  Even though they were unable to generalize their results to other fourth-generation tests, they predict that the other tests available will have the same problems and for clinicians to interpret results with caution.

About the Author
  • After earning my Bachelor of Science degree in biology/chemistry from Virginia Polytechnic Institute and State University (aka Va. Tech), I went on to complete clinical rotations in laboratory medicine at Roanoke Memorial Hospital. I spent the next 21 years working in healthcare as a clinical microbiologist. In 2015, I combined my fascination with medicine and passion for writing into a freelance career, and I haven't looked back. Even though my expertise is in microbiology and infectious diseases, I'm adept at writing about any medical topic. Being a freelance writer allows me to pursue a career where I can work at home with my two feline assistants, Luke and Grace. I'm a firm supporter of animal rights and volunteer for a local rescue during my free time. 
You May Also Like
MAR 08, 2020
Cardiology
MAR 08, 2020
Cashier and Healthcare Jobs Increase Risk of Heart Problems in Women
Stress has long been known to be a major risk factor for developing heart disease. Now, researchers from Drexel University in Philadelphia have found that ...
MAR 21, 2020
Neuroscience
MAR 21, 2020
Sugar May Change Brain Chemistry After Just 12 Days
Our brain’s reward system is crucial for learning new things. Relying on the release of neurotransmitter dopamine, it is also a key reason behind why...
MAR 23, 2020
Cell & Molecular Biology
MAR 23, 2020
How a Father's Diet Can Impact the Health of His Offspring
When fathers consume a diet high in fat or low in protein it can increase the risk of metabolic disorders like diabetes in their offspring....
MAR 25, 2020
Health & Medicine
MAR 25, 2020
Images of Lungs from COVID-19 Patients Reveal Diagnostic Significance
CT scans from 27 patients that first contracted Cornonavirus in Wuhan, China reveal signatures in the lungs that could help diagnose the progression of COVID-19...
MAR 27, 2020
Health & Medicine
MAR 27, 2020
Possible Link Between Marijuana Use and Heart Health
Research presented in a new study published in the Journal of the American College of Cardiology found that 2.3% of reported cannabis users have...
MAR 29, 2020
Cancer
MAR 29, 2020
MicroRNA as a New Way to Test for Lung Cancer
The most common, and most deadly, cancer across the world is lung cancer. If caught early, lung cancer has quite a low mortality rate. MicroRNAs may prove to be the answer....
Loading Comments...