Buffalo, NY, United States
Buffalo, NY, United States
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Provided are compositions that contain mammalian cells for use in detecting antibodies. The mammalian cells are modified such that they do not contain LEDGF protein. The mammalian cells are immobilized on a solid substrate. The compositions can also contain mammalian cells that contain the LEDGF protein. Methods for using the cell compositions in diagnostic approaches are included, as are kits for performing diagnostic tests.


Provided are compositions that contain mammalian cells for use in detecting antibodies. The mammalian cells are modified such that they do not contain LEDGF protein. The mammalian cells are immobilized on a solid substrate. The compositions can also contain mammalian cells that contain the LEDGF protein. Methods for using the cell compositions in diagnostic approaches are included, as are kits for performing diagnostic tests.


Malyavantham K.,Immco Diagnostics | Suresh L.,Immco Diagnostics
Autoimmunity Highlights | Year: 2017

Indirect immunofluorescence (IIF) using human epithelial cell (HEp-2) substrate is a widely used and the recommended method for screening of antinuclear antibodies (ANA). Dense fine speckled (DFS70) pattern on HEp-2 has been widely reported in various healthy and disease groups. Interpretation of DFS70 pattern can be challenging on a conventional HEp-2 substrate due to its similarity to some of the disease associated patterns. The high prevalence of DFS70 autoantibodies in normal population, lack of association with a particular disease group and a general negative association with systemic and ANA associated autoimmune rheumatic diseases (SARD/AARD) necessitates the confirmation of DFS70 pattern. Results using available commercial assays for confirmation of DFS70 autoantibodies do not always agree with IIF screening results further complicating the lab work flow and ANA algorithms. In this review, we discuss the prevalence of DFS70 antibodies and factors affecting the performance of IIF and DFS70 specific confirmatory assays. Factors that contribute to disagreement between DFS70 suspicion by IIF and confirmatory assays will also be discussed. In addition, we also describe a novel IIF HEp-2 substrate, and its positive impact on DFS70 reporting and ANA screening-confirmation algorithm. © 2017, The Author(s).


Suresh L.,Immco Diagnostics | Neiders M.E.,Immco Diagnostics | Neiders M.E.,State University of New York at Buffalo
Journal of Periodontology | Year: 2012

Background: Desquamative gingivitis (DG) is a common clinical manifestation of oral autoimmune vesiculobullous diseases (VBDs). Their polymorphous clinical presentations coupled with similar histologic features make diagnosis indistinguishableamong the different VBDs. Direct immunofluorescence (IF) studies are valuable gold-standard diagnostic tests that allow for discrimination among the various VBDs that present with DG. There have been no recent detailed analyses done that have used conventional light microscopy and direct IF in diagnosis to document the clinical associations of DG with various autoimmune oral diseases. The aim of this study is to examine retrospectively a large cohort of patients with DG for associated diseases and to determine the utility of direct IF and conventional light microscopy in establishing a definitive diagnosis. Methods: During a 14-month period, our laboratory in Buffalo, New York, received 239 consecutive archival cases of gingival biopsy with a clinical diagnosis of DG. These specimens were submitted to establish or rule out a diagnosis of a direct IF-positive VBD. The demographic, clinical, and microscopic findings were tabulated using established inclusion and diagnostic criteria. Results: Approximately half the number (48.1%) of biopsies received for direct IF studies were submitted by periodontists. Slightly more than half of the patients (53%) previously had biopsies submitted for both hematoxylin and eosin (H & E) and direct IF testing. There was a female predilection for all the diseases studied except for pemphigus and linear immunoglobulin A disease. Oral lichen planus was the most common disease presenting as DG, followed by pemphigoid. The clinical diagnosis of lichen planus correlated with the biopsy findings in 80% of the cases and with pemphigoid in 60%. Definitive diagnosis was rendered to ≈80% of the gingival biopsies submitted. Negative cases of direct IF presenting as DG had significant pathology, such as dysplasia and carcinoma, which would have been otherwise missed if H & E studies had not been performed. Conclusions: This study has the largest cohort of patients with DG suspected of VBD reported in the literature. The patients were predominantly females who had most often been seen by a periodontist. The definitive diagnosis of DG was most accurately achieved when H & E along with two biopsies for direct IF studies were submitted for testing. H & E studies were particularly important for definitive diagnosis of negative cases. Oral lichen planus was the most common disease presenting as DG, which is consistent with recent studies. Systemic connective tissue disorders that present as DG at initial clinical examination require direct IF and serum studies for a conclusive diagnosis. Clinical pathologic correlation, including history, presentation, H & E, and direct IF studies, are essential in establishing a definitive and differential diagnosis for cases presenting with DG.


Suresh L.,Immco Diagnostics | Malyavantham K.,Immco Diagnostics | Ambrus J.L.,Buffalo General Hospital
BMC Ophthalmology | Year: 2015

Background: Sjogren's syndrome (SS) is a chronic autoimmune disease mainly affecting salivary and lacrimal glands. Current diagnostic criteria for SS utilize anti-Ro and anti-La as serological markers. Animal models for SS have identified novel autoantibodies, anti-salivary gland protein 1 (SP1), anti-carbonic anhydrase 6 (CA6) and parotid secretory protein (PSP). These novel antibodies are seen in the animals at an earlier stage of SS than anti-Ro and anti-La. The current studies were designed to evaluate these novel autoantibodies in the sera of well-characterized patients with dry eyes and dry mouth and lip biopsies from the Sjogren's International Collaborative Clinical Alliance (SICCA) to determine if they indeed identify SS with less severe disease than patients expressing anti-Ro and anti-La. Methods: Sera were obtained from SICCA registry in patients for whom lymphocytic foci per 4 mm2 on the lip biopsies was either 0 (F = 0), <1 (F <1) or > 3 (F >3). ELISA assays were utilized to evaluate these sera for anti-Ro, anti-La, anti-SP1, anti-CA6, and anti-PSP. Results: In patients with dry eyes and dry mouth but F=0, increased expression of anti- CA6 was noted compared to the F <1 group (p=.032) or the F>3 group (p=.006). Neither anti-PSP nor anti-SP1 reached statistical significance because of the small numbers in the F0 group, although there was a trend for their expression to be higher in the F0 group. On the other hand, the expression of anti-Ro was significantly reduced in the F0 group compared to the F <1 (p=.0021) and F>3 (p=.0003) groups. The reduced expression of anti-La in the F0 group compared to the F <1 and F>3 groups did not quite reach statistical significance. Conclusions: Anti-Ro and anti-La identify patients with SS and more severe disease than anti-SP1, anti-CA6, and anti-PSP. More studies are needed to identify the timing in the course of SS when these different autoantibodies are expressed and/or whether they are expressed in patients with different clinical manifestations. © 2015 Suresh et al.; licensee BioMed Central.


Shen L.,State University of New York at Buffalo | Suresh L.,Immco Diagnostics | Lindemann M.,Immco Diagnostics | Xuan J.,State University of New York at Buffalo | And 3 more authors.
Clinical Immunology | Year: 2012

Sjogren's syndrome (SS) is defined by autoantibodies to Ro and La. The current studies identified additional autoantibodies in SS to salivary gland protein 1 (SP-1), carbonic anhydrase 6 (CA6) and parotid secretory protein (PSP). These autoantibodies were present in two animal models for SS and occurred earlier in the course of the disease than antibodies to Ro or La. Patients with SS also produced antibodies to SP-1, CA6 and PSP. These antibodies were found in 45% of patients meeting the criteria for SS who lacked antibodies to Ro or La. Furthermore, in patients with idiopathic xerostomia and xerophthalmia for less than 2. years, 76% had antibodies to SP-1 and/or CA6 while only 31% had antibodies to Ro or La. Antibodies to SP-1, CA6 and PSP may be useful markers for identifying patients with SS at early stages of the disease or those that lack antibodies to either Ro or La. © 2012 Elsevier Inc.


Patent
Immco Diagnostics | Date: 2011-03-10

Provided are compositions and methods for diagnosis of celiac disease. The compositions include recombinant proteins that contain tissue transglutaminase and deamidated gliadin sequences. The gliadin sequences are repeated in the recombinant proteins. Also provided is a method for identifying an individual as having celiac disease based on the presence of antibodies in a sample from the individual, where the anti-bodies specifically recognize the recombinant protein, and identifying the individual as not having celiac disease based on an absence of antibodies that specifically recognize the recombinant protein.


Patent
Immco Diagnostics | Date: 2014-07-09

A testing device has a base and multiple strips connected to the base. Multiple antigens are placed on each strip. The testing device or strips may be affixed to a sheet under a shield. Fluid can be applied to the testing device or the strips. The testing device can be used for biochemical testing, such as line immunoassay (LIA) testing.


Trademark
Immco Diagnostics | Date: 2012-03-27

Diagnostic reagents and kits for clinical or medical laboratory use; laboratory testing for autoimmune diseases.


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