Creative Testing Solutions (CTS) contributed to six research publications in 2025. Led by VP of Scientific Affairs Marion Lanteri, CTS’s research and development department, and team members across the organization greatly contribute to advancing scientific knowledge and support for clinical and experimental therapies. The following abstracts highlight CTS’s collaborative efforts in research, reflecting its partnership with the industry to ensure patient safety, and the development of new approaches in transfusion medicine, infectious disease monitoring, regenerative medicine, and more.
Currently, nucleic acid testing (NAT) platforms detect HIV-1 in plasma. Using whole blood (WB) could improve HIV-1 detectability as cellular elements may also contain HIV-1 nucleic acids. We used well-characterized paired WB/plasma panels to evaluate HIV-1 RNA detection inhibition by WB, specificity, and enhanced HIV-1 RNA detectability by WB compared to plasma. Panels included: spiked samples; NAT-/serology-, NAT+/serology+, and NAT-/serology+ blood donor samples; samples from persons with HIV (PWH) who started antiretroviral treatment (ART) at chronic infection stages; and from PWH under ART since acute/early infection. We found one false-positive result on WB testing of 100 NAT-/serology- blood donors, and evidence of modest HIV-1 detection inhibition. Among NAT-/serology+ donors, HIV-1 RNA detectability in plasma and WB was similar (P = 0.64). Among 50 PWH starting ART at chronic infection stages, detectability was 24% in plasma and 92% in WB (P < 0.001). Among 345 PWH on ART since acute/early infection, detectability was 10% in plasma and 16% in WB (P = 0.013). HIV-1 RNA detectability in both plasma and WB was progressively lower for earlier Fiebig stages at ART initiation. WB increased HIV-1 detectability relative to plasma in PWH who initiated ART at all but the earliest infection stages. We failed to find enhanced HIV-1 RNA detectability by WB in NAT-/serology+ blood donors, who may include elite controllers. Enhancing HIV-1 nucleic acid detectability could improve infection ascertainment among PWH on ART with blunted serologic reactivity; investigation of breakthrough infection in PrEP users; and potentially for virus rebound monitoring in HIV-1 cure studies.
Importance: Currently, tests to detect HIV genetic materials (RNA/DNA) are done using the liquid component of a blood sample (plasma). However, HIV may be present in blood cellular components, such as white cells and platelets. Here, we investigated if using whole blood (WB; liquid + cellular components) could improve HIV RNA detectability compared to plasma. WB increased HIV RNA detectability in persons with HIV under treatment, including those with early treatment initiation, but not among blood donors with positive HIV serology and undetectable HIV RNA in the donation screening. Enhancing HIV RNA/DNA detectability would support HIV diagnosis in cases with blunted serologic response, such as persons with early antiretroviral treatment initiation or pre-exposure prophylaxis users. It would also be useful for monitoring virus rebound in HIV cure studies and in blood donation screening, where high test sensitivity is required to guarantee the safety of the blood supply. Read more. >>
Following FDA guidance, US blood collectors changed donor deferral for men who have sex with men (MSM) from indefinite to a 12 month deferral in 2016 (12 m), and for MSM and several other exposure risks to 3 month deferrals in 2020 (3 m). We evaluated first-time donor (FTD) HIV incidence and demographics during these periods.
We estimated cross-sectional HIV incidence and incidence rate differences in FTD based on routine donation nucleic acid testing (NAT) and serology with additional limiting antigen (LAg)-Avidity immunoassay and viral load testing. We estimated incidence in the two policy periods (12 and 3 m), incidence trends in two-year intervals between 2015 and 2023, and used multivariable Poisson regression to assess demographic correlates of incident infection.
HIV incidence in FTD during the 12 m deferral period was 2.82 infections/105 person-years (PY) [95% CI: 2.12, 3.67] and during the 3 m deferral period, it was 1.88/105 PY (95% CI: 1.18, 2.67), a statistically significant decline (p < .05). Over the period 2015–2023, incidence was stable. Male sex, younger age, Black or African American race, Hispanic ethnicity, and residence in the South were associated with incident infection in regression analysis, but the time-based deferral policy periods were not.
HIV incidence in FTD did not increase between 2015 and 2023. An overall decline in HIV incidence in the 3 m deferral period compared with the 12 m deferral period was evident. These results provide no indication of an increased residual risk of transfusion-transmitted HIV from FTD in the United States with the reduced deferral periods.
© 2025 AABB. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA. Read more. >>
More than 85% of US adults had been infected with SARS-CoV-2 by the end of 2023. Continued serosurveillance of transmission and assessments of correlates of protection require robust detection of reinfections. We developed a serologic method for identifying reinfections in longitudinal blood donor data by assessing nucleocapsid (N) antibody boosting using a total immunoglobulin assay.
Receiver operating characteristic curve analysis yielded an optimal ratio of >1.43 (sensitivity 87.1%, specificity 96.0%). When prioritizing specificity, a ratio of >2.33 was optimal (sensitivity 75.3%, specificity 99.3%). In donors with higher anti-N reactivity levels before reinfection, sensitivity was reduced. Sensitivity could be improved by expanding the dynamic range of the assay through dilutional testing, from 38.8% to 66.7% in the highest reactivity group (signal-to-cutoff ratio before reinfection >150).
This study demonstrated that longitudinal testing for N antibodies can be used to identify reinfections and estimate total infection incidence in a blood donor cohort. Read more. >>
Syphilis is increasing globally, with limited monitoring of risk factors in asymptomatic, low-risk populations. Here, we investigate contemporary demographic and behavioral risk factors associated with active syphilis infection (ASI) in US blood donors.
Beginning with donations in October 2020, four US blood centers implemented standardized risk factor interviews for ASI in blood donors as part of a larger case–control study. Logistic regression models were used to assess ASI associations with demographics and behaviors within 12 months before donation. A conceptual framework explored causal ASI pathways.
Responses were obtained from 369 ASI cases and 868 controls; from all eligible cases, the enrollment rate was 16%. Risk factors in the multivariable-adjusted model included age between 40 and 54 years old (compared to 55+), Black race (compared to White), lower income, single/never married and separated/divorced or widowed status (compared to married or living together), first-time donation, gay/homosexual sexual orientation, having ≥2 male or ≥2 female sexual partners in the 12 months before donation, and a history of sexually transmitted infection. The conceptual risk framework suggests that important determinants of ASI include complex variables and mediators that may have not been fully captured by the questionnaire and regression analyses.
Although not fully defining causal relationships with ASI, our findings establish a baseline for factors associated with ASI among US blood donors, which can be used to refine the donor history questionnaire following the implementation of individual risk assessment and further surveillance efforts.
© 2025 The Author(s). Transfusion published by Wiley Periodicals LLC on behalf of AABB. Read more. >>
The implementation of revised blood donor deferral policies may change factors associated with HIV infection in donors. Here, we assessed factors associated with HIV in the U.S. blood donor population between 2015 and 2023.
Using exposure data obtained from interviews of HIV cases and matched controls, we investigated sociodemographic and behavioral factors associated with any HIV infection or recently acquired HIV infection, overall and by strata of deferral policy period (lifetime, 12-month and 3-month), for men who have sex with men and other potential risk groups using conditional logistic regression.
Multivariable analyses showed that several sociodemographic and behavioral factors were significantly associated with HIV infection, but with no clear evidence of changes in these factors across deferral policy periods. Similarly, several factors were significantly associated with recent HIV infection, with odds ratios similar to those observed for any HIV infection. An association between non-heterosexual orientation and HIV infection remained stable across deferral periods included in the study after adjustment for potential confounders. We found no evidence that non-heterosexual orientation is more strongly associated with recent than with any HIV infection among blood donors.
Our findings suggest no major impact of revised deferral policies on HIV risk factors among blood donors, nor among risk factors for any HIV and recent HIV infection in this population. These findings should be reassessed after sufficient accrual of data from the individual donor assessment deferral policy period.
© 2025 AABB. Read more. >>
The proportion of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections diagnosed by coronavirus disease 2019 (COVID-19) tests, including home antigen tests, is unknown. We detected infections among blood donors in the United States (US) by testing for nucleocapsid antibody (anti-N) seroconversion and administered a questionnaire to determine the proportion of those infections that were associated with a self-reported positive COVID-19 test. Among US blood donors with serologic evidence of SARS-CoV-2 infection who completed a survey, 47.7% reported an associated self-reported positive COVID-19 test. This proportion changed from July–December 2020 (44.9%) to July–December 2022 (54.8%). This study suggests many SARS-CoV-2 infections in adults are not diagnosed with a test.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused >1 million deaths in the United States (US) [1] and remains an important public health concern. Coronavirus disease 2019 (COVID-19) public health case surveillance has been unable to track undiagnosed and unreported infections. This is due to several factors, including individuals' lack of access to healthcare-based testing, use of home antigen tests that are not reported to public health [2, 3], and potentially a decreased public desire for testing. Furthermore, in the US, after the expiration of the COVID-19 pandemic–associated Public Health Emergency on 11 May 2023, many public health authorities stopped reporting COVID-19 case data [4]. The Centers for Disease Control and Prevention (CDC) previously recommended isolation and masking after testing positive for SARS-CoV-2 infection and currently recommends COVID-19 testing as an optional strategy to guide treatment and taking steps to avoid transmission to others [5]. However, little is known about the proportion of people with SARS-CoV-2 infections who have tested positive and how this has changed over time. This study estimated the proportion of US blood donors with serological evidence of SARS-CoV-2 infection who reported a survey-based positive COVID-19 test that coincided with their infection-induced antibody seroconversion interval.
Published by Oxford University Press on behalf of Infectious Diseases Society of America 2025. Read more. >>
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