RF-TURBILATEX
Intended Use:
Test for quantitative determination of Rheumatoid Factors by using Latex Turbidimetric method.
Summary:
Rheumatoid factors are a group of antibodies directed to determinants in the Fc portion of the immunoglobulin G molecule. Although rheumatoid factors are found in a number of rheumatoid disorders, such as systemic lupus erythematosus (SLE) and Sjogren’s syndrome, as well as in nonrheumatic conditions, its central role in clinic lies its utility as an aid in the diagnosis of rheumatoid arthritis (RA). A study of the ‘American College of Rheumatology’, shows that the 80.4% RA patients were RF positive.
Principle:
The RF-Turbilatex is a quantitative turbidimetric test for the measurement of RF in human serum or plasma. Latex particles coated with human gammaglobulin are agglutinated when mixed with samples containing RF. The agglutination causes an absorbance change, dependent upon the RF contents of sample that can be quantified by comparison from a calibrator of known RF concentration
Specification
| Methodology | Immunoturbidimetry |
| Reaction Type | Kinetic |
| Reaction Direction | Increasing |
| Sample Type | Human Serum or Plasma |
| R1:R2 Mixing Ratio | 4:1 |
| Primary Wavelength | 540 nm |
| Secondary Wavelength | NA |
| Blank Settings | Distilled Water |
| Blank Absorbance Limit | <0.300 |
| Reagent Volume Required Per Test | 1000 µl |
| Sample Volume Required Per Test | 7 µL |
| Delay Time | 10 seconds |
| Calibrator Available in the Kit | Yes |
| Factor | NA |
| Linearity | 160 IU/ml. |
| Automation | Enabled |
| Pack Sizes | 1×50 ml |
| Kit components | Reagent bottles – R1 and R2. 1 Calibrator vial. Instructions for Use. |
| Storage Temperature | 2- 80C |
| Shelf life | 24 months |
| Kit dimensions | 1×50 ml – 85x105x45 mm |
| Approx. weight of kit | 1×50 ml – 130 gms |
| Production Capacity | 600 mn ml per annum |