A Multiple Autoantibodies Immunological Test System is a diagnostic system designed to detect and measure multiple autoantibodies in human serum, plasma, or other biological samples. It is primarily used to aid in the diagnosis of autoimmune diseases, where the immune system mistakenly attacks the body’s own tissues.

Intended use of Multiple Autoantibodies Immunological Test

A Multiple Autoantibodies Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body’s own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body’s own tissues are injured by autoantibodies).

Intended use

Device is an in vitro diagnostic Immunological Test System intended for the qualitative and/or semi-quantitative detection of multiple autoantibodies (such as anticardiolipin antibodies, including igg, igm, and/or iga isotypes) in human serum or plasma specimens. These autoantibodies are biomarkers associated with autoimmune and thrombotic disorders, including antiphospholipid syndrome and related conditions. Results obtained with this device are intended to be used as an aid in the diagnosis and management of autoimmune disorders when evaluated in conjunction with clinical signs, symptoms, and other laboratory and diagnostic findings. The device is intended for use by trained laboratory personnel in clinical laboratory settings.

Device Description

Immunological Test System comprises reagents, controls, calibrators, and related components designed to detect multiple autoantibody analytes in human serum or plasma using immunochemical assay methodologies. Assay formats employed by MID devices include, but are not limited to:

• Enzyme-linked immunosorbent assay (ELISA)
• Chemiluminescent immunoassay (CLIA)
• Multiplex immunoassay platforms

Key Components

• Capture antigens or antigen complexes.
• Conjugated detection antibodies
• Calibrators
• Controls
• Buffers and diluents

Test System, Antineutrophil Cytoplasmic Antibodies (ANCA)

Intended use

ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the device. ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with Automated Fluorescence Microscope.

Device description

The ANCA (Ethanol) and ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum.

Kit components:

• ANCA (Formalin Fixed Human Neutrophils) Slides
• Positive Controls
• Negative Control
• Coverslips

Autoantibodies, Endomysia (Tissue Transglutaminase)

Intended use.

The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-heparin, Na+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.  The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgG class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-heparin, Na+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.

Device Description

Anti-tissue Transglutaminase ELISA (IgA)- The device is packaged as a kit containing: 12 microplate strips each containing eight antigen-coated wells and frame; three calibrators (2, 20, and 200 RU/mL); human serumbased IgA positive and negative controls; horseradish peroxidase (HRP)-conjugated rabbit anti-human IgA; ready-to-use sample buffer; 10x wash buffer concentrate; 3,3’,5,5’- tetramethylbenzidine (TMB) substrate; and sulfuric acid stop solution.  Anti-tissue Transglutaminase ELISA (IgG)- The device is packaged as a kit containing: 12 microplate strips each containing eight antigen-coated wells and frame; one cut-off calibrator (20 RU/mL); human serum-based IgG 3 positive and negative controls; horseradish peroxidase (HRP)-conjugated rabbit anti-human IgG; ready-to-use sample buffer; 10x wash buffer concentrate; 3,3’,5,5’-tetramethylbenzidine (TMB) substrate; and sulfuric acid stop solution.

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

Intended use.

LKM-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-liver/kidney microsome type 1 antibodies in human serum. The presence of anti-liver/kidney microsome type 1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of autoimmune hepatitis type.

Device Description

The LKM-1 kit includes one LKM-1 Reagent Cartridge, one vial of resuspension buffer, and one transfer pipette.

• LKM-1 coated paramagnetic beads, lyophilized.
• Assay buffer.
• Tracer IgG

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 (BP330)

Intended use.

The BP230-CF ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of immunoglobulin class IgG antibodies against BP 230 in human serum and plasma (K3-EDTA, Li+-heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

Device Description

The BP230-CF ELISA (IgG) test kit includes six microplate strips with eight break-off wells per strip, three calibrators, positive and negative controls, peroxidase-labelled rabbit anti-human IgG, sample buffer, TMB substrate, stop solution, and wash solution. The test works by coating wells with BP230-CF and adding diluted patient samples (1:101), calibrators, and controls, followed by a 30-minute incubation at room temperature. After washing to remove unbound material, an HRP enzyme conjugate is added, incubated for another 30 minutes, and washed again before adding TMB substrate. Following a final 15-minute incubation, a stop solution is added, and the color intensity is measured using a microplate reader at 450 nm, with a reference wavelength between 620–650 nm. The amount of antigen-specific bound antibody is proportional to the color intensity.

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Intended use.

The IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative or qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

Device Description

The Autoantibody (IA-2Ab) ELISA Kit contains components including:

• IA-2-coated ELISA wells and IA-2-biotin
• Five calibrators
• Positive and negative controls
• IA-2 Reaction Enhancer and Reconstitution Buffer
• Streptavidin-Peroxidase (SA-POD) and its Diluent
• Tetramethylbenzidine (TMB) Substrate
• Stop solution and Wash solution.

This ELISA test detects IA-2 autoantibodies by forming a bridge between IA-2 coated on the plate and IA-2-biotin in the liquid phase. Streptavidin-peroxidase (SA-POD) and TMB substrate create a color reaction, which is measured using an ELISA plate reader.

21-Hydroxylase Antibody (21-Ohab)

Intended use.

The Steroid 21- Hydroxylase Autoantibody (21- OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21- OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison’s disease (isolated) or Addison’s disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

Device Description

The 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit consists of the following components:

• Recombinant human21-OHAb-coated ELISA strip wells
• Kit Negative Control
• Kit Positive Control
• 21-OH Reaction Enhancer (colored red)
• 21-OH Biotin (lyophilized)
• 21-OHBiotin Reconstitution Buffer
• Streptavidin Peroxidase
• Tetramethylbenzidine Peroxidase Substrate
• Stop solution.
• Concentrated Wash Solution

Performance testing (Analytical Nonclinical) for Multiple Autoantibodies Immunological Test

• Precision/ Reproducibility
• Linearity/ assay reportable range
• Traceability, Stability, Expected values (controls, calibrators, or methods)
• Detection limit
• Analytical specificity
• Cross-reactivity
• Endogenous interference
• Assay cut-off
• Method comparison
• Matrix comparison

Clinical testing: Required for 510 k submissions.