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ENA IgG Dot Filtration Assay Kit

ENA IgG DOT Assay Kit is an in-vitro rapid test kit is used as an aid in the diagnosis of autoimmune connective tissue disorders.

ENA IgG Dot Assay Cassette

Intended Use

ENA IgG DOT Assay Kit is an in-vitro rapid test reagent kit for the qualitative detection of the IgG antibody specific to extractable Nuclear antigens (ENA) in human serum specimens. And this ENA IgG rapid test kit is intended to be used as an aid in the diagnosis of autoimmune connective tissue disorders.

ENA IgG Testing Principle

ENA IgG Dot assay kit is designed to detect IgG class of antibodies to different ENA antigens in human serum specimens. On the test region of the nitrocellulose membrane is pre-coated with immobilized ENAs. During the test, the any of the antibodies specific to ENA will be captured and bound on the membrane. Then, the subsequently added goat anti-human IgG antibody conjugated with colloidal gold is added, it will be caught by the bound ENA antibodies, and a red dot will develop in the test region, indicating a positive result.

ENA Antibody and Rheumatoid Arthritis

Extractable Nuclear Antigens (ENA) are soluble cytoplasmic and nuclear components. In recent years, six autoantibodies to a number of nuclear constituents, namely Ro, La, Sm, RNP, Scl-70 and Jo1, have been proved to be useful in the diagnosis of various connective tissue diseases. Antibodies to these antigens have particular associations with various connective tissue disorders. The detection of these antibodies, particularly those of the IgG class, offers an efficient test method for the laboratory testing of patients with various connective tissue diseases.

Extractable Nuclear Antibody (ENA) Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
ENA R522 Double Stranded DNA IgG DOT Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
How to Use

Double Stranded DNA IgG DOT Assay

General Information

(IVD Kit »-» Rheumarthritis -» Dot Immuno Gold Filtration Assay)

Catalog No.:ENA R522
Description:Double Stranded DNA IgG DOT Assay
Category:Rheumarthritis
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of DGFIA indirect

DGFIA Indirect Method Illustration

With indirect Dot filtration test kit, the millipore filtering membrane is pre-coated with purified or recombinant viral antigens. The detecting conjugate reagent is stored in a vial, whose main component is rabbit anti human IgG (anti-IgG) antibodies, which is conjugated with colloidal gold particles.

During the first step, sample is added to the sample well in the test cassette. The target IgG antibodies, if present, will be captured by the pre-coated antigens.

The wells are washed to remove unbound serum proteins. Then, the colloidal gold conjugate is added. If the target IgG antibodies have been captured in the first step, the IgG antibody will react with the added secondary antibody, anti-IgG conjugate, and red color will develop, indicating a positive result.

Information | Packing | Specimen | Principle