Intended Use
Enzyme immunoassay for the qualitative and quantitative determination of IgG antibodies against SS-B/La in human serum or plasma (EDTA, citrate, heparin).
Contents of Kit
1. MTP Microtiter Plate, coated with the SS-B / La antigen described above and hermetically packed in a foil laminate pouch together with a desiccant bag. The plate consists of 12 strips, each of which can be broken into 8 individual wells.
2. ENZCONJ IgG Enzyme Conjugate, 14 mL, ready-to-use, red coloured. Buffered solution containing stabilising protein, methylisothiazolone and bromonitrodioxane.
3. CAL A–F Calibrator A-F, 2,0 mL each, 0 - 0,60 - 2,0 - 6,0 - 20 and 60 U SS-B / La IgG / mL, ready-to-use, gradually blue coloured. Contain TBS, BSA, Tween and Na-azide.
4. CONTROL - & CONTROL + Negative and Positive Control, 2,0 mL each, ready-to-use, green and red coloured, respectively. Contain TBS, BSA, Tween and Na-azide.
5. SAMPLEDIL Sample Diluent, 100 mL, ready-to-use, orange coloured. Contains Tris-buffered saline (TBS), bovine serum albumin (BSA), Tween and Na-azide.
6. TMB SUBS TMB Substrate Solution, 14 mL, ready-to-use, colourless. Contains a buffered solution of TMB and H2O2. Contained in a vial impermeable to light.
7. WASHBUF CONC Wash Buffer, 100 mL, 10x-concentrate, blue coloured. Contains TBS, Tween and bromonitrodioxane.
8. STOP TMB Stop Solution (0,2 M H2SO4), 14 mL, colourless, ready-to-use.
Caution: sulfuric acid is corrosive.
9. Instructions for use
10. Lot-specific certificate of analysis
Performance Characteristics
Standardisation The test is standardised with a purified serum preparation containing IgG antibodies specifically directed at the SS-B / La antigen. This preparation is calibrated against a set of gradually positive sera, solely reserved for this purpose. The degree of sample reactivity is measured in arbitrary units (U/mL) since no international standard is available.
Analytical specificityThe test allows the specific determination of human IgG antibodies directed against SS-B / La. It has been validated (among other parameters) by means of the commercially available human reference sera of the "Center of Disease Control" (CDC, Atlanta, USA). The following results are typical:

Interference with anticoagulants (EDTA, Citrat, Heparin) in samples has been tested and no interference effects have been observed.
Homogeneity of the solid phaseMeasurement of the solid phase homogeneity is a regular QC part of each production lot. This is determined by 288-fold measurement of a positive but non-saturating sample on 3 selected plates. Acceptance criterion: mOD-coefficient of variation (cv) over the plates < 8%. The figure below shows a representative excerpt of such an analysis.


Frequency distribution of SS-B / La IgG This was analysed in a sera collective of blood donors, equally distributed by sex and age, and a collective of sera intended-positive in different ring trials or clinically defined and/or found positive for SS-B / La IgG autoantibodies according to a FDA-approved, CE-compliant reference ELISA. The following distribution of the analyte was observed:

ROC-analysis of these data was used to determine the cut-off as 10,0 U SS-B / La IgG / mL (9). The data presented here suggest a diagnostic specificity and sensitivity of the ELISA of 100 % for both parameters. These values apply for the measured sera only; other collectives may yield different results. In view of the low number of positive sera, particular caution is required when interpreting test sensitivity.


Detection Limit
The detection limit is defined as that concentration of analyte that corresponds to the mean absorbance of Sample Diluent plus 3-fold standard deviation (s). It was determined as < 0,2 U SS-B / La IgG per mL sample (n = 24).
Recommended measuring range: 0,5 - 50 U / mL
General Description
The present ELISA is intended for the quantitative or qualitative determination of IgG antibodies in human serum or plasma, directed against the SS-B / La antigen. This is a recombinant, highly purified
preparation of the human protein, expressed by baculovirus infected insect cells. The test is fast (incubation time 30 / 30 / 30 minutes) and flexible (divisible solid phase, ready-to-use reagents). Six calibrators allow quantitative measurements; a negative and a positive control check the assay performance.
SS-B / La IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) intended for the quantitative or qualitative determination of IgG class antibodies directed against SS-B / La in human serum or plasma samples. Its function is the aid to differential diagnosis of inflammatory autoimmune diseases, especially Sjoegren's syndrome and systemic lupus erythematosus.
General Notes
The present ELISA is intended for the quantitative or qualitative determination of IgG antibodies in human serum or plasma, directed against the SS-B / La antigen. This is a recombinant, highly purified
preparation of the human protein, expressed by baculovirus infected insect cells. The test is fast (incubation time 30 / 30 / 30 minutes) and flexible (divisible solid phase, ready-to-use reagents). Six calibrators allow quantitative measurements; a negative and a positive control check the assay performance.
SS-B / La IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) intended for the quantitative or qualitative determination of IgG class antibodies directed against SS-B / La in human serum or plasma samples. Its function is the aid to differential diagnosis of inflammatory autoimmune diseases, especially Sjoegren's syndrome and systemic lupus erythematosus.
Enzyme immunoassay for the qualitative and quantitative determination of IgG antibodies against SS-B/La in human serum or plasma (EDTA, citrate, heparin).