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 RUBAscan™ Semi-Quantitative Test Cards (150 tests) 30 test cards |
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| Cat. # | Desc. | Qty. | Unit |
| 262030 | RUBAscan™ Semi-Quantitative Test Cards (150 tests) 30 test cards (discontinued) | EA |
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The RUBAscan™ Card Test is a passive latex agglutination test for the qualitative detection of rubella IgG and IgM antibodies in human serum or as an aid in the determination of immune status. The RUBAscan Card Test can also be used to give semi-quantitative results when serial dilutions of properly paired specimens are tested to determine recent or active infection.
| Catalog # | Description | Quantity | Unit |
| 262030 | RUBAscan™ Semi-Quantitative Test Cards (150 tests) 30 test cards (discontinued) | EA |
The RUBAscan™ Card Test is a passive latex agglutination test for the qualitative detection of rubella IgG and IgM antibodies in human serum or as an aid in the determination of immune status. The RUBAscan Card Test can also be used to give semi-quantitative results when serial dilutions of properly paired specimens are tested to determine recent or active infection. The RUBAscan™ Card Test is a passive latex agglutination test for the qualitative detection of rubella IgG and IgM antibodies in human serum or as an aid in the determination of immune status. The RUBAscan Card Test can also be used to give semi-quantitative results when serial dilutions of properly paired specimens are tested to determine recent or active infection. The RUBAscan Card Test is based upon the well established principles of passive latex agglutination. Latex is sensitized according to a patented process using solubilized rubella virus antigens from disrupted virions. This latex reagent, when mixed with serum containing rubella antibodies on a card surface, will agglutinate, forming visible clumps. In the absence of antibody, or if the concentration is insufficient to react, the latex will remain smooth and evenly dispersed. In a qualitative sense, the presence of rubella antibodies is an indication of previous infection and presumptive of immunity.1-3 An interpretation of the test results can be used to evaluate the immune status of the individual with regard to resistance or susceptibility to primary rubella infection. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The RUBAscan Card Test correlates to Hemagglutination Inhibition (HAI) and approximates a 10 IU/mL sensitivity level using the 1:10 Qualitative Procedure. The semi-quantitative test differs in procedure by having provision for a primary specimen dilution and six consecutive test dilutions. Results are determined by dilution titers which are indicated by limiting dilutions containing sufficient antibody to agglutinate the added latex reagent. The RUBAscan Card Test is a more sensitive test than HAI, but correlation does exist between it and conventional hemagglutination inhibition procedures (cf., "Expected Values" and "Performance Characteristics"). Consequently, RUBAscan Card Test results can be related to a large existing body of knowledge drawn from HAI test data pertaining to the significance of antibody titers. Moreover, with properly collected specimen pairs, seroconversion of a four-fold titer rise can be used to diagnose recent or current infection. The RUBAscan Card Test is based upon the well established principles of passive latex agglutination. Latex is sensitized according to a patented process using solubilized rubella virus antigens from disrupted virions. This latex reagent, when mixed with serum containing rubella antibodies on a card surface, will agglutinate, forming visible clumps. In the absence of antibody, or if the concentration is insufficient to react, the latex will remain smooth and evenly dispersed. In a qualitative sense, the presence of rubella antibodies is an indication of previous infection and presumptive of immunity.1-3 An interpretation of the test results can be used to evaluate the immune status of the individual with regard to resistance or susceptibility to primary rubella infection. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The RUBAscan Card Test correlates to Hemagglutination Inhibition (HAI) and approximates a 10 IU/mL sensitivity level using the 1:10 Qualitative Procedure. The semi-quantitative test differs in procedure by having provision for a primary specimen dilution and six consecutive test dilutions. Results are determined by dilution titers which are indicated by limiting dilutions containing sufficient antibody to agglutinate the added latex reagent. The RUBAscan Card Test is a more sensitive test than HAI, but correlation does exist between it and conventional hemagglutination inhibition procedures (cf., "Expected Values" and "Performance Characteristics"). Consequently, RUBAscan Card Test results can be related to a large existing body of knowledge drawn from HAI test data pertaining to the significance of antibody titers. Moreover, with properly collected specimen pairs, seroconversion of a four-fold titer rise can be used to diagnose recent or current infection. The Control ++ is formulated to produce agglutination at a titer of 1:160 or greater. The Control + is formulated to produce agglutination at a titer of 1:10 ± one dilution. The Control– should show no agglutination. Titers should be reported as last dilution showing agglutination. Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent NCCLS guidance and CLIA regulations for appropriate Quality Control practices.
For in vitro Diagnostic Use. Reagents: Do not use beyond the expiration date. Upon removal from the refrigerator, allow reagents to warm to room temperature (23–29°C) before use. Refrigerate at 2–8°C. DO NOT FREEZE. Reagents should be recapped and returned to refrigeration when not in use. To assure proper drop delivery when dispensing RUBAscan Latex Antigen (Reagent A), the dispensing bottle must be held vertically. Reagent A has been prepared from disrupted vaccine strain virus which has been judged to be inactivated by bioassay procedures. The serum controls are derived from human blood tested by an FDA (U.S. Food and Drug Administration)-approved method for the presence of the antibody to HIV (human immunodeficiency virus) and HBsAg (hepatitis B surface antigen) and found to be nonreactive.
Warning: Reagents contain sodium azide. Very toxic by inhalation, in contact with skin, and if swallowed. Contact with acids liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up. Test Cards: Cards must be flat for proper reactions. If necessary, flatten cards by bowing back in a direction opposite to that of the curl. Care should be taken not to finger-mark the test areas, since this may result in an oily deposit and improper test results. Use each card once and discard. Store cards in the original package in a dry area at room temperature. Reading of Test Results: To help differentiate weak agglutination from no agglutination, a brief hand rotation of the card must be made following mechanical rotation. Results should be read promptly under a high intensity incandescent lamp. Fluorescent lighting is generally insufficient to distinguish minimally reactive results. The use of magnification in reading test results is not recommended. Rotation: The recommended speed for mechanical rotation is 100 ± 2 rpm, but rotation between 95 and 110 rpm does not significantly affect the results obtained. The rotator should circumscribe a circle approximately two centimeters in diameter in the horizontal plane. A moistened humidifying cover should be used to prevent drying of test specimens during rotation. | |||||||||||||||||||||||||||||||||
Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.
