Product Specification

                                Anti-ACA IgM ELISA Test Kit (Serum/Plasma)

INTENDED USE

     This kit is a qualitative detection of human serum/plasma of Anticardiolipin IgM antibody. The kit is suitable for clinical screening and diagnosis.

ACA antibody is a group of auto-antibodies against a variety of negatively charged phospholipids, It can be used as one of the diagnostic criteria for antiphospholipid antibody syndrome (including thrombosis), spontaneous abortion, thrombocytopenia and central nervous system (CNS) lesions. ACA IgM can be used as prospective index of spontaneous abortion; Positive ACA was significantly associated with CNS thrombosis in patients with systemic lupus erythematosus (SLE).

SUMMARY AND CLINICAL SIGNIFICANCE

    Vitamin D is a fat-soluble  hormone precursor that is mainly produced in the skin by exposure to sunlight. Vitamin D is biologically inert and must undergo hydroxylation steps to become active. Our body can only synthesize vitamin D3. Vitamin D2 is taken up with fortified food or given by supplements. Physiologically, vitamin D3 and D2 are bound to the vitamin D-binding protein (VDBP) in plasma and transported to the liver to become 25-hydroxy vitamin D (25-OH vitamin D). As 25-OH vitamin D represents the major storage form, its blood concentration is used to assess the overall vitamin D status. More than 95 % of 25-OH vitamin D, measurable in serum, is 25-OH vitamin D3 whereas 25-OH vitamin D2 reaches measurable levels only in patients taking vitamin D2 supplements. Vitamin D is essential for bone health. In children, severe deficiency leads to rickets. In elderly, the risk of falling has been attributed to vitamin D deficiency due to muscle weakness. Moreover, low 25-OH vitamin D concentrations are associated with lower bone mineral density. Insufficiency has also been linked to diabetes, cancer, cardiovascular disease, and autoimmune diseases. Both dietary supplements of Vitamin D that are currently available in the market (Vitamin D2 and Vitamin D3) are converted to 25-OH Vitamin D in the liver. The sum of the concentrations of 25-OH Vitamin D2 and 25-OH Vitamin D3 in serum or plasma is referred to as “Total 25-OH Vitamin D”. Accurate monitoring of total 25-OH Vitamin D level is critical in clinical settings. Vitamin D deficient patients who are prescribed a daily Vitamin D supplement should regularly monitor their serum or plasma Vitamin D levels in order to reach an optimal level and prevent their 25-OH Vitamin D concentrations from reaching excessive levels that are considered toxic. The Vitamin D total assay employs special antibodies to capture both 25-hydroxyvitamin D3 and D2. This assay is intended for the quantitative determination of total 25-OH vitamin D in human serum and plasma, as an aid in the assessment of vitamin D sufficiency.

PRINCIPLE

This kit uses indirect ELISA principle to detect ACA IgM. Purified ACA antigen is pre-coated on the microplate, the ACA IgM antibody in sample will combine with ACA antigen first, then combine with enzyme-labeled second antibody to form antigen-antibody-antibody complex, and shows blue color in the microplate. This kit is used for the specific detection of ACA IgM in human serum/plasma.

MAIN COMPONENTS

PREPARATIONS

1.  Allow all specimens and reagents to reach room temperature (~25°C) and mix thoroughly by gentle inversion before use.

2.Prepare Wash Buffer by diluting Wash Concentrate 20-fold with deionized water. The diluted wash solution is stable in room temperature for at least one week.

ATTENTIONS

1. Do not exchange reagents from different lots or use reagents from other commercially available kits. The components of the kit are precisely matched for optimal performance of the tests.

2. Specimens with Hyperlipidemia and icterus show no effects on the detection results. But specimen with severe hemolysis will affect the color of the result, other test methods are suggested to use.

3. Allow the reagents and specimens to reach room temperature before use. Shake reagent gently before use.

4. Concentrated washing liquid will produce crystal at room temperature, should be diluted completely before use.

5. Never reuse microplate sealing membrane.

6. Samples containing anti-sperm antibody, anti-endometrial antibody will not affect the results.

7. Each component of the kit was inactivated, however, it should be regarded as potentially infectious.

PRECAUTION FOR USERS

1. Handling should preclude any pipetting by mouth. Use only pipettes with disposable tips for each specimen.

2.Do not mix materials from different master lots. Do not use kit components beyond the expiration date.

3.All materials should be brought to room temperature before use.