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
JUL 19, 2020
Cardiology
Common Biomarker Could Predict Heart Disease
JUL 19, 2020
Common Biomarker Could Predict Heart Disease
Heart failure is usually associated with conditions like high blood pressure and coronary artery disease. But there may ...
JUL 25, 2020
Cardiology
Neurofibromatosis and How It Affects Heart Health
JUL 25, 2020
Neurofibromatosis and How It Affects Heart Health
Genetic diseases are persistent and often cause minor issues that can develop into more prominent problems later. Take n ...
JUL 30, 2020
Immunology
Sunshine Could Lower Your Risk of Developing MS
JUL 30, 2020
Sunshine Could Lower Your Risk of Developing MS
In multiple sclerosis, or MS, the insulating sheaths around nerve cells in the brain and spinal cord called myelin becom ...
JUL 28, 2020
Cardiology
Looking to Newborns for Help Healing Scars on the Heart
JUL 28, 2020
Looking to Newborns for Help Healing Scars on the Heart
Scars are a badge of honor to many, but they are really just a consequence of the body’s repair response. The body ...
AUG 04, 2020
Cardiology
Does Chronic Anxiety Affect Heart Health?
AUG 04, 2020
Does Chronic Anxiety Affect Heart Health?
Anxiety is something that is talked about far more often nowadays. In recent years, it has even been linked to a variety ...
AUG 07, 2020
Plants & Animals
Do Tasmanian Devils Hold the Key to Tumor Inhibition?
AUG 07, 2020
Do Tasmanian Devils Hold the Key to Tumor Inhibition?
Thanks to a historic cartoon character, Tasmanian devils are commonly regarded as cantankerous and ferocious creatures. ...
Loading Comments...