The Hidden Gap in Infant HIV Diagnosis: A Call for Complementary Diagnostics in the Point-of-Care and Prophylaxis Era

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Abstract The remarkable success of Prevention of Mother-to-Child Transmission (PMTCT) programs has significantly lowered infant HIV prevalence. However, this success, along with widespread maternal and infant prophylaxis and the increasing reliance on Point-of-Care (POC) diagnostics, has inadvertently created a new diagnostic challenge. Our research quantifies a critical, previously overlooked gap in HIV detection among infants born to HIV-positive mothers. We observed that a substantial proportion (over 18%) of HIV-infected infants now present with extremely low viral loads (Ct values above 31), which is likely due to the suppressive effects of prophylaxis. Importantly, external quality assessment studies reveal that most current POC platforms in use cannot be single-handedly relied on to detect HIV at these low concentrations. This means that sole reliance on POC testing risks leaving a significant cohort of approximately 18% of HIV-infected infants undiagnosed for prolonged periods, leading to severe clinical outcomes and undermining PMTCT gains. We emphasize the essential role of highly sensitive conventional PCR platforms, capable of accurately interpreting very low positive results, and advocate for a complementary diagnostic strategy where conventional PCR serves as a confirmatory test for all HIV-exposed infants. This article highlights the urgent need for a revised diagnostic approach to optimize PMTCT strategies and ensure timely care for every HIV-exposed infant.

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