Implementing point-of-care hemoglobin A1C testing in an obstetrics outpatient clinic.

BACKGROUND: A1C ≥6.0% is associated with increased risk of adverse outcomes in pregnant diabetic patients. A1C testing is recommended by the American Diabetes Association as a secondary measure of glycemic control in pregnant patients. OBJECTIVE: To determine the utility of A1C point-of-care testing (POCT) during pregnancy to facilitate rapid counseling and diabetes care, particularly in relatively low-income transient patient populations. METHODS: We performed a single-center, retrospective analysis of patients presenting to an outpatient obstetrics office with routine, in-laboratory A1C testing, before and after the implementation of POCT for A1C (n = 70 and n = 75, respectively). Demographics, results, physician referral to a nutritionist, counseling, and outcomes were retrieved from patient electronic medical records. RESULTS: In total, 9% and 23% of the in-laboratory and POCT groups, respectively, were referred for nutrition services (P = .02). Of these, 22% of the in-laboratory group and 42% of the POCT group received immediate counseling (P < .01). An inverse correlation was observed between A1C level at study entry and gestational weeks at delivery, with a Pearson r value of -0.39 (-0.58 to -0.16) for the in-laboratory group and -0.38 (-0.57 to -0.14) for the POCT group. No statistically significant difference in pregnancy outcomes was observed. CONCLUSION: Implementation of A1C POCT was associated with immediate counseling and management of the health of pregnant patients, but was not associated with improved outcomes, in a low-resource patient population.

Automating the Detection of IV Fluid Contamination Using Unsupervised Machine Learning.

BACKGROUND: Intravenous (IV) fluid contamination is a common cause of preanalytical error that can delay or misguide treatment decisions, leading to patient harm. Current approaches for detecting contamination rely on delta checks, which require a prior result, or manual technologist intervention, which is inefficient and vulnerable to human error. Supervised machine learning may provide a means to detect contamination, but its implementation is hindered by its reliance on expert-labeled training data. An automated approach that is accurate, reproducible, and practical is needed. METHODS: A total of 25 747 291 basic metabolic panel (BMP) results from 312 721 patients were obtained from the laboratory information system (LIS). A Uniform Manifold Approximation and Projection (UMAP) model was trained and tested using a combination of real patient data and simulated IV fluid contamination. To provide an objective metric for classification, an "enrichment score" was derived and its performance assessed. Our current workflow was compared to UMAP predictions using expert chart review. RESULTS: UMAP embeddings from real patient results demonstrated outliers suspicious for IV fluid contamination when compared with the simulated contamination's embeddings. At a flag rate of 3 per 1000 results, the positive predictive value (PPV) was adjudicated to be 0.78 from 100 consecutive positive predictions. Of these, 58 were previously undetected by our current clinical workflows, with 49 BMPs displaying a total of 56 critical results. CONCLUSIONS: Accurate and automatable detection of IV fluid contamination in BMP results is achievable without curating expertly labeled training data.

Clinical specificity of two assays for immunoglobulin kappa and lambda free light chains.

OBJECTIVES: Free light chain (FLC) assays and the ratio of κ/λ are recommended for diagnosis, prognosis and monitoring of plasma cell dyscrasias (PCD). Limited data exists on FLC clinical specificity in patients diagnosed with other conditions. METHODS: We assessed the κ, λ, and κ/λ FLC ratio using the FreeLite assay and the Sebia FLC ELISA assay in 176 patients with clinical presentations of fatigue, anemia, polyclonal hypergammaglobulinemia, joint disorders, kidney disease and non PCD-cancers with no monoclonal protein observed on serum protein electrophoresis or MASS-FIX immunoglobulin isotyping. Manufacturer defined reference intervals (RI) and glomerular filtration rate (GFR) specific RI (renal RI) were utilized. RESULTS: For the κ/λ ratio, 68.7 % (121/176) of specimens on the FreeLite and 87.5 % (154/176) of specimens on the Sebia assay were within RI. For κ, 68.2 % (120/176) and 72.2 % (127/176) of results were outside RI for FreeLite and Sebia respectively. For λ, 37.5 % (66/176) and 84.1 % (148/176) of FreeLite and Sebia results were outside RI. With FreeLite and Sebia, patients with kidney disease (n=25) had the highest κ/λ ratios. 44 patients (25.0 %) had GFR <60 mL/min/BSA. When renal RI were applied, 13.6 % had a FLCr outside the renal RI with FreeLite, and 4.5 % with Sebia. CONCLUSIONS: In a cohort of patients with signs and symptoms suggestive of PCDs, but ultimately diagnosed with other conditions, Sebia FLC had improved clinical specificity relative to FreeLite, if one was using an abnormal κ/λ ratio as a surrogate for monoclonality.

Elevated Level of Circulating but Not Urine S100A8/A9 Identifies Poor COVID-19 Outcomes.

The alarmin calprotectin (S100A8/A9) is thought to drive a cytokine storm, a hallmark of severe COVID-19. Recent studies report circulating S100A8/A9 levels can distinguish COVID-19 severity but have only been conducted in non-U.S. cohorts and mainly focus on serum S100A8/A9 levels. Thus, we quantified S100A8/A9 in serum and urine samples from a hospital cohort in St. Louis, Missouri, to expand the understanding of S100A8/A9 as a prognostic biomarker for COVID-19. Elevated S100A8/A9 serum levels were observed in ICU patients (n = 49, p = 0.0370) and patients with fatal cases of COVID-19 (n = 76, p = 0.0018). We observed no correlation in the S100A8/A9 levels in matched serum and urine samples. Our results support the association of serum S100A8/A9 levels with COVID-19 severity and suggest that further investigation of urine S100A8/A9 as a COVID-19 biomarker is not warranted.

GPT-4 Underperforms Experts in Detecting IV Fluid Contamination.

BACKGROUND: Specimens contaminated with intravenous (IV) fluids are common in clinical laboratories. Current methods for detecting contamination rely on insensitive and workflow-disrupting delta checks or manual technologist review. Herein, we assessed the utility of large language models for detecting contamination by IV crystalloids and compared its performance to multiple, but variably trained healthcare personnel (HCP). METHODS: Contamination of basic metabolic panels was simulated using 0.9% normal saline (NS), with (n = 30) and without (n = 30) 5% dextrose (D5NS), at mixture ratios of 0.10 and 0.25. A multimodal language model (GPT-4) and a diverse panel of 8 HCP were asked to adjudicate between real and contaminated results. Classification performance, mixture quantification, and confidence was compared by Wilcoxon rank sum. RESULTS: The 95% CIs for accuracy were 0.57-0.71 vs 0.73-0.80 for GPT-4 and HCP, respectively, on the NS set and 0.57-0.57 vs 0.73-0.80 on the D5NS set. HCP overestimated severity of contamination in the 0.10 mixture group (95% CI of estimate error, 0.05-0.20) for both fluids, while GPT-4 markedly overestimated the D5NS mixture at both ratios (0.16-0.33 for NS, 0.11-0.35 for D5NS). There was no correlation between reported confidence and likelihood of a correct classification. CONCLUSIONS: GPT-4 is less accurate than trained HCP for detecting IV fluid contamination of basic metabolic panel results. However, trained individuals were imperfect at identifying contaminated specimens implying the need for novel, automated tools for its detection.

Accuracy of a Glycerol Dehydrogenase Assay for Ethylene Glycol Detection.

INTRODUCTION: Ethylene glycol (EG) is a frequently considered toxicant in poisoned patients. Definitive diagnosis relies on gas chromatography (GC), but this is unavailable at most hospitals. A glycerol dehydrogenase (GDH)-based assay rapidly detects EG. A rapid turnaround time and wide availability of necessary instrumentation suggest this method could facilitate the rapid detection of EG. METHODS: This is a prospective, observational analysis of banked, remnant serum samples submitted to the laboratory of a large, multi-hospital healthcare system. Samples were submitted over a 12-month period for the explicit purpose of testing for suspected EG ingestion. All samples underwent GC and the GDH-based assay. RESULTS: Of the 118 analyzed samples, 88 had no EG detected by GC, and 30 were "positive." At the manufacturer's threshold of 6 mg/dL EG, there was 100% (95%CI; 88.7-100) positive percent agreement (PPA) and 98% (92.1-99.6) negative percent agreement (NPA). Adjusted to a threshold of 9 mg/dL, both the PPA and NPA were 100%. Deming regression of the observed concentrations revealed a slope of 1.16 (1.01 to 1.32) and intercept of -5.3 (-8.9 to -1.7). CONCLUSIONS: The GDH assay provides a sensitive and specific method for the detection and quantification of EG that is comparable to a GC-based method. More widespread use of this rapid, inexpensive assay could improve the care of patients with suspected toxic alcohol exposure. Further study is needed to evaluate the test performance in real-time patient treatment decisions.

Seroprevalence of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) antibodies among healthcare personnel in the Midwestern United States, September 2020-April 2021.

Objective: To determine the prevalence of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) IgG nucleocapsid (N) antibodies among healthcare personnel (HCP) with no prior history of COVID-19 and to identify factors associated with seropositivity. Design: Prospective cohort study. Setting: An academic, tertiary-care hospital in St. Louis, Missouri. Participants: The study included 400 HCP aged ≥18 years who potentially worked with coronavirus disease 2019 (COVID-19) patients and had no known history of COVID-19; 309 of these HCP also completed a follow-up visit 70-160 days after enrollment. Enrollment visits took place between September and December 2020. Follow-up visits took place between December 2020 and April 2021. Methods: At each study visit, participants underwent SARS-CoV-2 IgG N-antibody testing using the Abbott SARS-CoV-2 IgG assay and completed a survey providing information about demographics, job characteristics, comorbidities, symptoms, and potential SARS-CoV-2 exposures. Results: Participants were predominately women (64%) and white (79%), with median age of 34.5 years (interquartile range [IQR], 30-45). Among the 400 HCP, 18 (4.5%) were seropositive for IgG N-antibodies at enrollment. Also, 34 (11.0%) of 309 were seropositive at follow-up. HCP who reported having a household contact with COVID-19 had greater likelihood of seropositivity at both enrollment and at follow-up. Conclusions: In this cohort of HCP during the first wave of the COVID-19 pandemic, ∼1 in 20 had serological evidence of prior, undocumented SARS-CoV-2 infection at enrollment. Having a household contact with COVID-19 was associated with seropositivity.

Association between SARS-CoV-2 Symptoms, Ct Values, and Serological Response in Vaccinated and Unvaccinated Healthcare Personnel.

BACKGROUND: SARS-CoV-2 vaccines are effective at reducing symptomatic and asymptomatic COVID-19. Limited studies have compared symptoms, threshold cycle (Ct) values from reverse transcription (RT)-PCR testing, and serological testing results between previously vaccinated vs unvaccinated populations with SARS-CoV-2 infection. METHODS: Healthcare personnel (HCP) with a positive SARS-CoV-2 RT-PCR test within the previous 14 to 28 days completed surveys including questions about demographics, medical conditions, social factors, and symptoms of COVID-19. Ct values were observed, and serological testing was performed for anti-nucleocapsid (anti-N) and anti-Spike (anti-S) antibodies at enrollment and 40 to 90 days later. Serological results were compared to HCP with no known SARS-CoV-2 infection and negative anti-N testing. RESULTS: There were 104 unvaccinated/not fully vaccinated and 77 vaccinated HCP with 2 doses of an mRNA vaccine at time of infection. No differences in type or duration of symptoms were reported (P = 0.45). The median (interquartile range [IQR]) Ct was 21.4 (17.6-24.6) and 21.5 (18.1-24.6) for the unvaccinated and vaccinated HCP, respectively. Higher anti-N IgG was observed in unvaccinated HCP (5.08 S/CO, 3.08-6.92) than vaccinated (3.61 signal to cutoff ratio [S/CO], 2.16-5.05). Anti-S IgG was highest among vaccinated HCP with infection (34 285 aribitrary units [AU]/mL, 17 672-61 775), followed by vaccinated HCP with no prior infection (1452 AU/mL, 791-2943), then unvaccinated HCP with infection (829 AU/mL, 290-1555). Anti-S IgG decreased 1.56% (0.9%-1.79%) per day in unvaccinated and 0.38% (0.03%-0.94%) in vaccinated HCP. CONCLUSIONS: Vaccinated HCP infected with SARS-CoV-2 reported comparable symptoms and had similar Ct values relative to unvaccinated. However, vaccinated HCP had increased and prolonged anti-S and decreased anti-N response relative to unvaccinated.

Limited Utility of Free Triiodothyronine Testing.

BACKGROUND: Free triiodothyronine (fT3) testing is most useful when thyroid stimulating hormone (TSH) is suppressed, and free thyroxine (fT4) is normal or decreased. These laboratory values in a symptomatic patient are referred to as T3 thyrotoxicosis. Standards for fT3 reflex testing have not been established. Herein, we examined the clinical utility of fT3 with the goal of identifying a TSH cutoff in the context of normal/decreased fT4 that maximizes the utility of measuring fT3. METHODS: TSH, fT4, and fT3 results between January 2016 and October 2021 were extracted from the laboratory information system and grouped if resulted on the same day for the same patient. Frequency of biochemical T3 thyrotoxicosis was evaluated at different TSH cutoffs and in outpatient vs inpatient settings. RESULTS: Of the 4366 TSH-fT4-fT3 results, 70 (1.6%) were consistent with biochemical T3 thyrotoxicosis. The common reasons were previously diagnosed hyperthyroidism on antithyroid medication (n = 28) or hypothyroidism on thyroid medication (n = 18) and newly diagnosed hyperthyroidism (n = 20, 0.5%). The likelihood of detecting T3 thyrotoxicosis increased with lower TSH cutoff (<0.3 µIU/mL, 10.3% vs <0.0 1µIU/mL, 27.6%). All patients with newly diagnosed hyperthyroidism had TSH <0.01 µIU/mL. Higher frequency of T3 thyrotoxicosis was observed in the outpatient setting (34%) relative to the inpatient setting (14%, P < 0.001) when TSH < 0.01 µIU/mL. CONCLUSIONS: T3 thyrotoxicosis is a relatively rare diagnosis and fT3 measurement has limited utility in the vast majority of patients. A fT3 reflex for patients with TSH <0.01 µIU/mL and normal/low fT4 may improve clinical utility and reduce unnecessary testing, especially in the outpatient setting.

Intensive care unit sinks are persistently colonized with multidrug resistant bacteria and mobilizable, resistance-conferring plasmids.

Contamination of hospital sinks with microbial pathogens presents a serious potential threat to patients, but our understanding of sink colonization dynamics is largely based on infection outbreaks. Here, we investigate the colonization patterns of multidrug-resistant organisms (MDROs) in intensive care unit sinks and water from two hospitals in the USA and Pakistan collected over 27 months of prospective sampling. Using culture-based methods, we recovered 822 bacterial isolates representing 104 unique species and genomospecies. Genomic analyses revealed long-term colonization by Pseudomonas spp. and Serratia marcescens strains across multiple rooms. Nanopore sequencing uncovered examples of long-term persistence of resistance-conferring plasmids in unrelated hosts. These data indicate that antibiotic resistance (AR) in Pseudomonas spp. is maintained both by strain colonization and horizontal gene transfer (HGT), while HGT maintains AR within Acinetobacter spp. and Enterobacterales, independent of colonization. These results emphasize the importance of proactive, genomic-focused surveillance of built environments to mitigate MDRO spread. IMPORTANCE Hospital sinks are frequently linked to outbreaks of antibiotic-resistant bacteria. Here, we used whole-genome sequencing to track the long-term colonization patterns in intensive care unit (ICU) sinks and water from two hospitals in the USA and Pakistan collected over 27 months of prospective sampling. We analyzed 822 bacterial genomes, representing over 100 different species. We identified long-term contamination by opportunistic pathogens, as well as transient appearance of other common pathogens. We found that bacteria recovered from the ICU had more antibiotic resistance genes (ARGs) in their genomes compared to matched community spaces. We also found that many of these ARGs are harbored on mobilizable plasmids, which were found shared in the genomes of unrelated bacteria. Overall, this study provides an in-depth view of contamination patterns for common nosocomial pathogens and identifies specific targets for surveillance.

Method Comparison and Workflow Differences Using the Same Free Light Chain Assay on 2 Analyzer Platforms.

BACKGROUND: The Freelite assay (The Binding Site) is utilized to quantify serum immunoglobulin free light chains (sFLC), which is crucial for diagnosing and monitoring plasma cell dyscrasias (PCDs). Using the Freelite test, we compared methods and evaluated workflow differences across two analyzer platforms. METHODS: sFLC concentrations were measured in 306 fresh serum specimens (cohort A) and 48 frozen specimens with documented sFLC >20 mg/dL (cohort B). Specimens were analyzed on the Roche cobas 8000 and Optilite analyzers using the Freelite κ and λ assays. Performance was compared using Deming regression. Workflow was compared by assessing turnaround time (TAT) and reagent usage. RESULTS: For cohort A specimens, Deming regression revealed a slope of 1.04 (95% CI, 0.88-1.02) and an intercept of -0.77 (95% CI, -0.57 to 1.85) for sFLCκ and a slope of 0.90 (95% CI, -0.04 to 1.83) and intercept of 1.59 (95% CI, -3.12 to 6.25) for sFLCλ. Regression of the κ/λ ratio revealed a slope of 2.44 (95% CI, 1.47-3.41) and intercept of -8.13 (95% CI, -16.82 to 0.58) with a concordance kappa of 0.80 (95% CI, 0.69-0.92). The proportion of specimens with TAT >60 min was 0.33% and 8% for the Optilite and cobas, respectively (P < 0.001). The Optilite required 49 (P < 0.001) and 12 (P = 0.016) fewer tests for sFLCκ and sFLCλ relative to the cobas. Cohort B specimens showed similar but more dramatic results. CONCLUSIONS: Analytical performance of the Freelite assays was comparable on the Optilite and cobas 8000 analyzers. In our study, the Optilite required less reagent, had a slightly reduced TAT, and eliminated manual dilutions for samples with sFLC concentrations >20 mg/dL.

Utility of Commercially Available Quantitative hCG Immunoassays as Tumor Markers in Trophoblastic and Non-Trophoblastic Disease.

BACKGROUND: The use of quantitative human chorionic gonadotropin (hCG) as a tumor marker is widely accepted despite lack of FDA-approval for oncology. Differences in iso- and glycoform recognition among hCG immunoassays is well established, exhibiting wide inter-method variability. Here, we assess the utility of 5 quantitative hCG immunoassays for use as tumor markers in trophoblastic and non-trophoblastic disease. METHODS: Remnant specimens were obtained from 150 patients with gestational trophoblastic disease (GTD), germ cell tumors (GCT), or other malignancies. Specimens were identified by review of results from physician-ordered hCG and tumor marker testing. Five analyzer platforms were used for split specimen analysis of hCG: Abbott Architect Total, Roche cobas STAT, Roche cobas Total, Siemens Dimension Vista Total, and Beckman Access Total. RESULTS: Frequency of elevated hCG concentrations (above reference cutoffs) was highest in GTD (100%), followed by GCT (55% to 57%), and other malignancies (8% to 23%). Overall, the Roche cobas Total detected elevated hCG in the greatest number of specimens (63/150). Detection of elevated hCG in trophoblastic disease was nearly equivalent among all immunoassays (range, 41 to 42/60). CONCLUSIONS: While no immunoassay is likely to be perfect in all clinical situations, results for the 5 hCG immunoassays evaluated suggest that all are adequate for use of hCG as a tumor marker in gestational trophoblastic disease and select germ cell tumors. Further harmonization of hCG methods is needed as serial testing for biochemical tumor monitoring must still be performed using a single method. Additional studies are needed to assess the utility of quantitative hCG as a tumor marker in other malignant disease.

SARS-CoV-2 Omicron boosting induces de novo B cell response in humans.

The primary two-dose SARS-CoV-2 mRNA vaccine series are strongly immunogenic in humans, but the emergence of highly infectious variants necessitated additional doses and the development of vaccines aimed at the new variants1-4. SARS-CoV-2 booster immunizations in humans primarily recruit pre-existing memory B cells5-9. However, it remains unclear whether the additional doses induce germinal centre reactions whereby re-engaged B cells can further mature, and whether variant-derived vaccines can elicit responses to variant-specific epitopes. Here we show that boosting with an mRNA vaccine against the original monovalent SARS-CoV-2 mRNA vaccine or the bivalent B.1.351 and B.1.617.2 (Beta/Delta) mRNA vaccine induced robust spike-specific germinal centre B cell responses in humans. The germinal centre response persisted for at least eight weeks, leading to significantly more mutated antigen-specific bone marrow plasma cell and memory B cell compartments. Spike-binding monoclonal antibodies derived from memory B cells isolated from individuals boosted with either the original SARS-CoV-2 spike protein, bivalent Beta/Delta vaccine or a monovalent Omicron BA.1-based vaccine predominantly recognized the original SARS-CoV-2 spike protein. Nonetheless, using a more targeted sorting approach, we isolated monoclonal antibodies that recognized the BA.1 spike protein but not the original SARS-CoV-2 spike protein from individuals who received the mRNA-1273.529 booster; these antibodies were less mutated and recognized novel epitopes within the spike protein, suggesting that they originated from naive B cells. Thus, SARS-CoV-2 booster immunizations in humans induce robust germinal centre B cell responses and can generate de novo B cell responses targeting variant-specific epitopes.

Implementation of high-sensitivity troponin with a rapid diagnostic algorithm reduces emergency department length of stay for discharged patients.

INTRODUCTION: High sensitivity troponin (hs-cTn) and diagnostic algorithms are used to rapidly triage patients with symptoms of acute myocardial infarction in emergency departments (ED). However, few studies have evaluated the impact of simultaneously implementing hs-cTn and a rapid rule-out algorithm on length of stay (LOS). METHODS: We assessed the impact of transitioning from contemporary cTnI to hs-cTnI in 59,232 ED encounters over three years. hs-cTnI was implemented with an orderable series that included baseline, two-, four-, and six-hour specimens collected at provider discretion and operationalized with an algorithm to calculate the change in hs-cTnI from baseline and provide interpretations of "insignificant", "significant," or "equivocal." Patient demographics, results, chief complaint, disposition, and ED LOS were captured from the electronic medical record. RESULTS: cTnI was ordered for 31,875 encounters prior to hs-cTnI implementation and 27,357 after. The proportion of cTnI results above the 99th percentile upper reference limit decreased from 35.0% to 27.0% for men and increased from 27.8% to 34.8% for women. Among discharged patients, the median LOS decreased by 0.6 h (0.5-0.7). LOS among discharged patients with a chief complaint of chest pain decreased by 1.0 h (0.8-1.1) and further decreased by 1.2 h (1.0-1.3) if the initial hs-cTnI was below the limit of quantitation. The rate of acute coronary syndrome upon re-presentation within 30 days did not change post-implementation (0.10% versus 0.07%). CONCLUSION: Implementation of an hs-cTnI assay with a rapid rule-out algorithm decreased ED LOS among discharged patients, particularly among those with a chief complaint of chest pain.

Data-Driven Anomaly Detection in Laboratory Medicine: Past, Present, and Future.

BACKGROUND: Anomaly detection is an integral component of operating a clinical laboratory. It covers both the recognition of laboratory errors and the rapid reporting of clinically impactful results. Procedures for identifying laboratory errors and highlighting critical results can be improved by applying modern data-driven approaches. CONTENT: This review will prepare the reader to appraise anomaly detection literature, identify common sources of anomalous results in the clinical laboratory, and offer potential solutions for common shortcomings in current laboratory practices. SUMMARY: Laboratories should implement data-driven approaches to detect technical anomalies and keep them from entering the medical record, while also using the full array of clinical metadata available in the laboratory information system for context-dependent, patient-centered result interpretations.

Qualitative and quantitative detection of SARS-CoV-2 antibodies from dried blood spots.

INTRODUCTION: Dried blood spot (DBS) sampling is a minimally invasive method for specimen collection with potential multifaceted uses, particularly for serosurveillance of previous SARS-CoV-2 infection. In this study, we assessed DBS as a potential specimen type for assessing IgG and total (including IgG and IgM) antibodies to SARS-CoV-2 in vaccinated and naturally infected patients. METHODS: Six candidate buffers were assessed for eluting blood from DBS cards. The study utilized one hundred and five paired plasma specimens and DBS specimens from prospectively collected SARS-CoV-2 vaccinated individuals, remnants from those with PCR confirmed SARS-CoV-2 infections, or remnants from those without history of infection or vaccination. All specimens were tested with the Siemens SARS-CoV-2 total assay (COV2T) or IgG assay (sCOVG). RESULTS: The lowest backgrounds were observed with water and PBS, and water was used for elution. Relative to plasma samples, DBS samples had a positive percent agreement (PPA) of 94.4% (95% CI: 94.9-100%) for COV2T and 79.2 (68.4-87.0) for sCOVG using the manufacturer's cutoff. The NPA was 100 % (87.1-100.0 and 85.13-100) for both assays. Dilution studies revealed 100% (95% CI: 90.8-100%) qualitative agreement between specimen types on the COV2T assay and 98.0% (88.0-99.9%) with the sCOVG using study defined cutoffs. CONCLUSION: DBS specimens demonstrated high PPA and NPA relative to plasma for SARS-CoV-2 serological testing. Our data support feasibility of DBS sampling for SARS-CoV-2 serological testing.