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Cardiovascular diseases (CVD) are among the most preventable chronic disorders accounting for about one-third of general mortality around the globe. Micronutrients have been shown to have a significant impact on cardiovascular health. Micronutrients have been looked at as the most adoptable lifestyle choice which could reduce the burden of disease around the world. In this context, it is important to study the levels of micronutrients and see their correlation to cardiac disease biomarkers. The present study, has attempted to investigate the relationship between the diverse class of micronutrients and serum levels of the key lipids and lipoproteins. A retrospective analysis was carried out between the serum levels of micronutrients and vital cardiovascular markers. The study was carried out in a group of 358 individuals tested for the Cardio Health and Micronutrients Panel at Vibrant America Clinical Laboratory. The study population was categorized based on the serum concentration of lipids and lipoproteins into 3 groups ‘Low’ ‘Normal’ and ‘High’ and the levels of micronutrients were compared among these groups. The results revealed a significant association of several cardiovascular markers with vitamins including Vit D, Vit E, Vit K, and minerals including zinc, iron, calcium, magnesium, and amino acids including leucine, isoleucine, and valine. Quantitative analysis by Pearson’s correlation exhibited a negative correlation of asparagine with serum levels of cholesterol and LDL. Amino acids such as cysteine, isoleucine, and valine were found to have a significant negative correlation with HDL. A positive correlation was observed between valine and serum levels of LDL and Apo B. Vitamins such as Vit A, Vit D3, Vit E, and Vit K1 were found to have a strong positive correlation with levels of total cholesterol and triglycerides. The study summarizes micronutrients and modulation of several lipid markers which are critical for the management of cardiovascular diseases. Micronutrients such as vitamins B1, B3, asparagine, and glutamine have a strong positive association, and fat-soluble vitamins, and BCAA has a strong negative association with cardiovascular health.

Biomarkers are early predictors of various disorders, circulating level of C-reactive protein is a sensitive biomarker of systemic inflammation and may also be associated with the development of diabetic, hepatic, and cardiovascular diseases. In the present study, we aimed to investigate the association between circulating levels of high sensitive C-reactive protein (hs-CRP) and various biomarkers for hepatic, diabetic, and cardiovascular health. The retrospective analysis included 438 individuals who were tested for these panels simultaneously at Vibrant America Clinical Laboratory. The study population included free-living individuals without any preexisting clinical conditions. Among the cardiovascular markers, a positive correlation and significant association was found between high levels of hs-CRP and the serum levels of triglycerides (r = 0.0964, p

Objective: Wheat-related disorders are a spectrum of disorders associated with different autoimmune and non-autoimmune diseases. However, it is unclear whether these wheat-related disorders lead to adverse health effects such as cardiovascular risk, nutritional deficiencies etc. The objective of the study was to explore the lipid profiles and the nutritional status of subjects with wheat-related disorders to understand the potential threat of wheat on cardiovascular risk and nutritional deficiency. Method: A total of 1041 subjects who showed wheat-related symptoms were initially tested for the wheat protein antibody panel (Wheat Zoomer (WZ) panel and Coeliac Disease (CD) panel), then for cardiovascular panel and the micronutrient panel at Vibrant America Clinical Laboratory. Results: Subjects with both Wheat Zoomer positivity (WZ+) and Coeliac Disease positivity (CD+) had significantly low levels of high-density lipoproteins (HDL) (279/483(57.8%) and 29/47(61.7%) respectively), but only subjects with WZ + had low levels of Apo A1 (44/424(9.5%)), and high levels of Omega 6 fatty acids (53/334(15.9%)). None of the micronutrients tested showed a significant imbalance in WZ + subjects. Conclusion: Subjects with positive serology for WZ have deranged blood lipid profiles but did not show any significant micronutrient deficiency. Hence, our results showcase a significant association of wheat-related disorders to cardiovascular risk.

Background: Thyroid alterations have adverse effects on other health systems in the body, and reproductive system is one of the most affected organs. Here, we perform a comprehensive analysis on the effects of different thyroid abnormalities on sexual and reproductive-related hormones in both men and women in different age groups. Method: A comprehensive analysis was performed on 15,043 subjects within the reproductive age (15 - 49 years). They were tested for thyroid markers (TSH, FT4, anti-TPO, anti-Tg) and 13 reproductive hormones in Vibrant America Clinical Laboratory between March 2016 to July 2018. The alterations of each reproductive hormone in hypothyroidism, hyperthyroidism, anti-TPO+ anti-Tg+ groups were evaluated. Results: A total of 10,626 women was tested. Women with hypothyroidism had elevated cortisol and low SHBG and DHEA-S. Women with hyperthyroidism showed elevated total testosterone and SHBG. Women seropositive for anti-TPO had elevated total testosterone and low cortisol. Women seropositive for anti-Tg had low parathyroid hormones. Similarly, a total of 4417 men was tested. Men with hypothyroidism had low IGF-I. Similarly, men with hyperthyroidism had low DHEA-S, but elevated estradiol, FSH, LH and prolactin. Men seropositive for anti-TPO had elevated SHBG and low progesterone. Men seropositive for anti-Tg had elevated progesterone. The reproductive and related hormone levels of age group 36 - 49 showed the most variations. Conclusion: Our results clearly show that individuals with different thyroid alterations have different effects on reproductive health, especially in the age group 36 - 49. Hence, routine testing and follow-up checkups on reproductive system would be beneficial for individuals in the age group 36 - 49 with thyroid disorders.

Micronutrients are involved in various vital cellular metabolic processes including thyroid hormone metabolism. This study aimed to investigate the correlation between serum levels of micronutrients and their effects on thyroid parameters. The correlation of serum levels of micronutrients and thyroid markers was studied in a group of 387 healthy individuals tested for thyroid markers (T4, T3, FT4, FT3, TSH, anti-TPO, RT3, and anti-Tg) and their micronutrient profile at Vibrant America Clinical Laboratory. The subjects were rationalized into three groups (deficient, normal, or excess levels of micronutrients), and the levels of their thyroid markers were compared. According to our results, deficiency of vitamin B2, B12, B9 and Vit-D25[OH] ( p < 0.05 ) significantly affected thyroid functioning. Other elemental micronutrients such as calcium, copper, choline, iron, and zinc ( p < 0.05 ) have a significant correlation with serum levels of free T3. Amino acids asparagine (r = 0.1765, p < 0.001 ) and serine (r = 0.1186, p < 0.05 ) were found to have a strong positive correlation with TSH. Valine, leucine, and arginine ( p < 0.05 ) also exhibited a significant positive correlation with serum levels of T4 and FT4. No other significant correlations were observed with other micronutrients. Our study suggests strong evidence for the association of the levels of micronutrients with thyroid markers with a special note on the effect of serum levels of certain amino acids.

Current serological immunoassays have inherent limitations for certain infectious diseases such as Lyme disease, a bacterial infection caused by Borrelia burgdorferi in North America. Here we report a novel method of manufacturing high-density multiplexed protein microarrays with the capacity to detect low levels of antibodies accurately from small blood volumes in a fully automated system. A panel of multiple serological markers for Lyme disease are measured using a protein microarray system, Lyme Immunochip, in a single step but interpreted adhering to the standard two-tiered testing algorithm (enzyme immunoassay followed by Western blot). Furthermore, an enhanced IgM assay was supplemented to improve the test’s detection sensitivity for early Lyme disease. With a training cohort (n = 40) and a blinded validation cohort (n = 90) acquired from CDC, the Lyme Immunochip identified a higher proportion of Lyme disease patients than the two-tiered testing (82.4% vs 70.6% in the training set, 66.7% vs 60.0% in the validation set, respectively). Additionally, the Immunochip improved sensitivity to 100% while having a lower specificity of 95.2% using a set of investigational antigens which are being further evaluated with a large cohort of blinded samples from the CDC and Columbia University. This universal microarray platform provides an unprecedented opportunity to resolve a broad range of issues with diagnostic tests, including multiplexing, workflow simplicity, and reduced turnaround time and cost.

Background Antibody diagnostics play an important role in disease detection and can potentially aid in monitoring of the immune responses to see if an individual has developed immunity. Developing high throughput diagnostics which does not involve handling of infectious material becomes imperative in the case of pandemics such as the recent outbreak of SARS-CoV2. Methods A protein microarray technology was used to detect the plurality of antibody response to four novel antigens namely S1 glycoprotein, Receptor binding domain (RBD), S2 glycoprotein and Nucleoprotein of the novel coronavirus named SARS-CoV2 using serum samples. A DBS card was additionally used to compare its performance with a venipuncture-based serum separator tube (SST) draw. Results The three main subclasses of antibodies IgM, IgA and IgG were analyzed to see the variations in immune responses in the affected population and compared to their microbial RT-PCR based NP swab results. The clinical sensitivity and specificity were determined to be 99.67% and 99.77%. In the matrix comparison study, which would enable patients to test without risk of transmitting the virus, DBS (Dried Blood Spot) matched with higher than 98% accuracy to a venipuncture-based SST collection. Conclusion Multiplex testing enables higher sensitivity and specificity which is essential while establishing exposure on a population scale. This flexible platform along with a discrete collection methodology would be crucial and broadly useful to scale up testing in current and future pandemics. Minimum sample volume that can be collected using DBS cards can be processed in this multiplex pillar plate format enabling the capacity to provide the reliability of high throughput analyzers while having the ease of collection similar to rapid tests.

Background: Detection of autoantibodies has played a consolidate role in diagnosis of systemic autoimmune disorders. A cascade autoantibody testing is usually performed by employing antinuclear antibodies (ANA) test as a first screening test and the other tests as second level determinations. Here, we present that supplementing extractable nuclear antigens (ENA) tests to the ANA test may capture more autoimmunity and provide critical medical information at an early stage. In this study, we evaluated the clinical significance of a multiplex ANA + ENA panel. Methods: A cohort of 110 subjects, identified as ANA negative but ENA positive, were followed up for two years. The detection of their ANA and anti-ENA autoantibodies was assessed with a multiplex ANA + ENA panel at Vibrant America Clinical Laboratory. Results: During two years of multi-visit follow-up, 23 out of 110 subjects (20.9%) were found to become ANA positive within an average of 385 (±144) days. Histone (50/110, 45.5%) and Chromatin (25/110, 22.7%) antibodies were the most frequently found antibodies at their first visits. The subjects who were positive for RNP (5/8, 62.5%) and SSA (Ro) (10/22, 45.5%) have the highest ratio of conversion to positive ANA. No significant correlation was observed between the conversion frequency and the number of anti-ENA antibodies being carried. Conclusion: This study, which followed up on the subjects who had disparate ANA and ENA test results, showed that anti-ENA antibodies may exist years earlier than ANA. Combining ENA tests with ANA screening may reduce false negatives and improve sensitivity.

Background Rapid detection of a wide range of etiologic agents is essential for appropriate treatment and control of gastrointestinal (GI) infections. A variety of microbial species including bacteria, viruses, parasites, and fungi have been recognized as diarrheagenic enteric pathogens. However, multiplex testing of various targets in a single reaction needs further improvement because of its limitation in species and throughput. Results This study aims at developing and evaluating a DNA microarray-based qualitative multiplexed polymerase chain reaction (PCR) assay, Vibrant GI pathogen panel (GPP), for simultaneous detection of 27 enteric GI pathogenic targets (16 bacteria, 5 viruses, 4 parasites, and 2 fungi) directly from stool specimens. Limits of detection ranged from 102 to 104 cells/mL for bacteria, 102 to 103 cells/mL for parasites, 102 to 103 RNA copies/mL for viruses, and 102 to 103 cells/mL for fungi. Performance characteristics were determined using 27 Quantitative Genomic DNAs, 212 spiked stool specimens, 1067 clinical and archived stool specimens. Overall sensitivity was 95.9% (95% CI 92.4–98.1) and specificity was 100% (95% CI 99.9–100). Polymicrobial detections contained either two or three organisms was 20.2% (35/173) of positive clinical specimens and 3.3% (35/1055) of all clinical specimens. Conclusion The Vibrant GPP is a comprehensive, high-throughput, and rapid DNA microarray to provide etiologic diagnosis of GI infections in the laboratory setting.

Even though most thyroid subjects are undiagnosed due to nonspecific symptoms, universal screening for thyroid disease is not recommended for the general population. In this study, our motive is to showcase the early appearance of thyroid autoantibody, anti-TPO, prior to the onset of thyroid hormone disruption; hence the addition of anti-TPO in conjunction with traditional thyroid markers TSH and FT4 would aid to reduce the long-term morbidity and associated health concerns. Here, a total of 4581 subjects were tested multiple times for TSH, FT4, anti-TPO, and anti-Tg and followed up for 2 years. We streamlined our subjects into two groups, A1 (euthyroid at first visit, but converted to subclinical/overt hypothyroidism in follow-up visits) and A2 (euthyroid at first visit, but converted to hyperthyroidism in follow-up visits). According to our results, 73% of hypothyroid subjects (from group A1) and 68.6% of hyperthyroid subjects (from group A2) had anti-TPO 252 (±33) and 277 (±151) days prior to the onset of the thyroid dysfunction, respectively. Both subclinical/overt hypothyroidism and hyperthyroidism showed a significantly higher percentage of subjects who had anti-TPO prior to the onset of thyroid dysfunction compared to the combined control group. However, there was no significant difference in the subjects who had anti-Tg earlier than the control group. Further assessment showed that only anti-TPO could be used as a standalone marker but not anti-Tg. Our results showcase that anti-TPO appear prior to the onset of thyroid hormone dysfunction; hence testing anti-TPO in conjunction with TSH would greatly aid to identify potentially risk individuals and prevent long-term morbidity.

Background and Aims. Rheumatoid arthritis (RA) and celiac disease (CD) are members of the autoimmune disease family while they have been shown to share multiple aspects in epidemiology and clinical manifestations. The aim of this study was to assess the presence of wheat protein antibodies in RA seropositive subjects and the presence of RA diagnostic markers in subjects with seropositive wheat-related disorders including CD. Methods. Serum samples were collected from 844 subjects with joint pain and/or gastrointestinal symptoms and tested by a CD panel (anti-tTG and anti-DGP), a Wheat Zoomer (WZ) antibody panel (IgG/IgA to 14 wheat proteins), and a RA panel (anti-CCP and anti-RF). Retrospective analysis was completed using de-identified clinical data and test results. Results. The prevalence of RA markers was first investigated in CD- or WZ-positive subjects and negative controls. 49 subjects were seropositive in the CD panel with 10 (20%) RA positivity. 605 subjects were seropositive in the WZ panel with 106 (18%) RA positivity. 222 subjects were seronegative in either panels with 12 (6%) RA positivity. Next, the frequency of the CD markers and the clinically relevant wheat protein antibodies were investigated in the RA-positive subjects and negative controls. 128 subjects in this cohort were seropositive in the RA panel with 10 (8%) CD positivity and 106 (83%) WZ positivity, compared to 716 RA seronegative controls with 39 (5%) CD positivity and 499 (70%) WZ positivity. Conclusions. Our data presents an apparent trend of overlapped serological antibody biomarker positivity in RA and wheat-related disorders.

Celiac disease (CeD) has characteristics of an autoimmune disease, such as increased antibody levels to tissue transglutaminase (tTG). However, assays to measure these biomarkers in blood samples do not identify patients with sufficient accuracy for diagnosis or monitoring of CeD. We aimed to discover biomarkers of CeD derived from neoepitopes of deamidated gliadin peptides (DGP) and tTG fragments and to determine if immune reactivity against these epitopes can identify patients with CeD with mucosal healing.We analyzed serum samples from 90 patients with biopsy-proven CeD and 79 healthy individuals (controls) for immune reactivity against the tTG-DGP complex (discovery cohort). A fluorescent peptide microarray platform was used to estimate the antibody-binding intensity of each synthesized tTG-DGP epitope. We validated our findings in 82 patients with newly diagnosed CeD and 217 controls. We tested the ability of our peptide panel to identify patients with mucosal healing (based on the histologic analysis) using serum samples from patients with treated and healed CeD (n = 85), patients with treated but unhealed CeD (n = 81; villous atrophy despite a adhering a gluten-free diet), patients with untreated CeD (n = 82) and disease controls (n = 27), villous atrophy without CeD), and healthy controls (n = 217). Data were analyzed using principal component analysis followed by machine learning and support vector machine modeling.We identified 172 immunogenic epitopes of the tTG-DGP complex. We found significantly increased immune reactivity against these epitopes vs controls. In the both cohort, the set of neoepitopes derived from the tTG-DGP complex identified patients with CeD with 99% sensitivity and 100% specificity. Serum samples from patients with untreated CeD had the greatest mean antibody-binding intensity against the tTG-DGP complex (32.5 ± 16.4). The average antibody-binding intensity was significantly higher in serum from patients with treated but unhealed CeD mucosa (15.1 ± 7.5) than in patients with treated and healed CeD mucosa (5.5 ± 3.4) (P.001). The assay identified patients with mucosa healing status with 84% sensitivity and 95% specificity.We identified immunogenic epitopes of the tTG-DGP complex, and found that an assay to measure the immune response to epitopes accurately identified patients with CeD, as well as patients with mucosal healing. This biomarker assay might be used in detection and monitoring of patients with CeD.