Antinuclear IgG Dot Immunoassay Kit

ANA IgG Dot Assay Kit

ANA IgG dot filtration rapid test kit is a quick assay kit for the detection of antinuclear IgG antibody in human serum.

Intended Use

ANA IgG dot filtration rapid test kit is a Dot Immuno Gold Filtration Assay (DIGFA) kit, intended to be used to detect the IgG antibody specific to nuclear factor in human serum specimen, and is intended to be used as an aid in the diagnosis of the disease of Rheumatoid Arthritis.

Why ANA Testing Matter

Auto-antibodies are present in low titers in the general population. But in about 5% of the population, the ANAs concentration is elevated, and about half of this 5% personnel have some autoimmune disease, which include lupus, scleroderma, Sjögren's syndrome, polymyositis/dermatomyositis, mixed connective tissue disease, drug-induced lupus, and autoimmune hepatitis. So the detection of Antinuclear IgG antibody has to be considered with the rheumatoid arthritis blood test, before the final clinical conclusion is reached.

AFP as A Tumor Marker

Anti-nuclear antibodies (ANAs, also known as anti-nuclear factor or ANF) are autoantibodies specific to the nucleus cells. These autoantibodies can attack the body's tissues as if they were foreign intruders.

Antinuclear Antibody (ANA) Test Kits: Principle, Packing...

Cat. No.	Description (& Details)	Specimen	PCS/Box	Quan. per CTN	Quantity (Tests)
AnA R122	Antinuclear IgG Dot Assay	serum	25	Bulk: 1200 PCS Boxed: 36 Boxes

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General Info.
Packing
Specimen
Principle

General Information

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

Catalog No.:	AnA R122
Description:	Antinuclear 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

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.