United States
|
|
| Product Center | |
 VDRL Antigen 10 x 0.5 mL |
|
| Cat. # | Desc. | Qty. | Unit |
| 240765 | VDRL Antigen 10 x 0.5 mL | 10 | EA |
VDRL Antigen with Buffered Saline is recommended for use in the Venereal Disease Research Laboratory (VDRL)1 test for the detection of reagin, an antibody-like substance, by the qualitative and quantitative slide flocculation tests.
VDRL Test Control Serum Set is recommended for use in the quality control testing of VDRL Antigen by the slide flocculation test.
| Catalog # | Description | Quantity | Unit |
| 240765 |
VDRL Antigen 10 x 0.5 mL
With 60 mL buffered saline
|
10 | EA |
VDRL Antigen with Buffered Saline is recommended for use in the Venereal Disease Research Laboratory (VDRL)1 test for the detection of reagin, an antibody-like substance, by the qualitative and quantitative slide flocculation tests. VDRL Test Control Serum Set is recommended for use in the quality control testing of VDRL Antigen by the slide flocculation test. VDRL Antigen with Buffered Saline is recommended for use in the Venereal Disease Research Laboratory (VDRL)1 test for the detection of reagin, an antibody-like substance, by the qualitative and quantitative slide flocculation tests. VDRL Test Control Serum Set is recommended for use in the quality control testing of VDRL Antigen by the slide flocculation test. Treponema pallidum is the causative agent of syphilis. Syphilis is a chronic infection with many clinical manifestations which occur in distinct stages. Specific laboratory tests are recommended for the detection of each stage of the disease.2-4 The VDRL Antigen is a nontreponemal antigen composed of cardiolipin cholesterol and lecithin. The nontreponemal tests measure anti-lipid antibodies, which are formed by the host in response to lipids released from damaged host cells early in infection with T. pallidum, and lipid-like material from the treponemal cell surface.5 During syphilis infection, an antibody-like substance called reagin can be detected in the patient's serum. In syphilis infection of the central nervous system, reagin can be detected in the cerebrospinal fluid (CSF). Reactive nontreponemal tests confirm the diagnosis in the presence of early or late lesion syphilis. They offer a clue in latent subclinical syphilis, and are effective tools for detecting cases in epidemiologic investigations. Nontreponemal tests are superior to the treponemal test for following the response to therapy.3 Nontreponemal antigen tests are not entirely specific for syphilis, nor do they have satisfactory sensitivity in all stages of syphilis. Whenever the results of a nontreponemal antigen test disagree with the clinical impression, a treponemal antigen test such as the FTA-ABS2,3 should be performed. Nontreponemal tests such as the VDRL are used to screen patient serum, while treponemal tests such as the FTA-ABS are used for confirmation. The likelihood of obtaining a reactive VDRL test result in various stages of untreated syphilis has been reported as follows.3
Treponema pallidum is the causative agent of syphilis. Syphilis is a chronic infection with many clinical manifestations which occur in distinct stages. Specific laboratory tests are recommended for the detection of each stage of the disease.2-4 The VDRL Antigen is a nontreponemal antigen composed of cardiolipin cholesterol and lecithin. The nontreponemal tests measure anti-lipid antibodies, which are formed by the host in response to lipids released from damaged host cells early in infection with T. pallidum, and lipid-like material from the treponemal cell surface.5 During syphilis infection, an antibody-like substance called reagin can be detected in the patient's serum. In syphilis infection of the central nervous system, reagin can be detected in the cerebrospinal fluid (CSF). Reactive nontreponemal tests confirm the diagnosis in the presence of early or late lesion syphilis. They offer a clue in latent subclinical syphilis, and are effective tools for detecting cases in epidemiologic investigations. Nontreponemal tests are superior to the treponemal test for following the response to therapy.3 Nontreponemal antigen tests are not entirely specific for syphilis, nor do they have satisfactory sensitivity in all stages of syphilis. Whenever the results of a nontreponemal antigen test disagree with the clinical impression, a treponemal antigen test such as the FTA-ABS2,3 should be performed. Nontreponemal tests such as the VDRL are used to screen patient serum, while treponemal tests such as the FTA-ABS are used for confirmation. The likelihood of obtaining a reactive VDRL test result in various stages of untreated syphilis has been reported as follows.3
User Quality Control of VDRL Antigen Suspension 1. Prepare a fresh antigen suspension each testing day. Once prepared, it should be used within 8 h. 2. Store the prepared antigen suspension at 23 – 29șC. 3. Test antigen suspension reactivity with control sera (Reactive, Weakly Reactive and Nonreactive). Test serum dilutions within 1 h after heat inactivation. 4. Use the antigen suspension only if it produces the expected reactivity with the control sera (Reactive, Weakly Reactive and Nonreactive) comparable to results obtained with the reference antigen. 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. VDRL Antigen is 0.03% cardiolipin and 0.9% cholesterol dissolved in absolute alcohol with sufficient lecithin (approximately 0.18 – 0.20%) to produce standard reactivity. It is prepared with modifications according to the directions given by Harris, Rosenberg and Riedel.6 Cardiolipin and lecithin are prepared according to directions given by Pangborn.7,8,9 VDRL Buffered Saline is a 1% sodium chloride solution, pH 6.0 ± 0.1, with 0.5% formaldehyde as a preservative. Nontreponemal Antigen Reactive Serum is a lyophilized human serum with 0.02% thimerosal as a preservative which is standardized to provide a reactive reading when tested according to the USR or VDRL test procedure. VDRL Weakly Reactive Serum is a lyophilized human serum with 0.02% thimerosal as a preservative which is standardized to provide a weakly reactive reading when tested according to the VDRL test procedure. Nontreponemal Antigen Nonreactive Serum is a lyophilized human serum with 0.02% thimerosal as a preservative which is standardized to provide a nonreactive reading when tested according to the USR or VDRL test procedure. 1. For in vitro Diagnostic Use. 2. WARNING: POTENTIAL BIOHAZARDOUS REAGENTS. Each donor unit used in preparation of VDRL Test Control Serum Set was tested by an FDA licensed method for the presence of the antibody to human immunodeficiency virus (HIV) as well as for hepatitis B surface antigen (HbsAg) and found to be negative (were not repeatedly reactive). Because no test method can offer complete assurance that HIV, hepatitis B virus or other infectious agents are absent, these reagents should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological and Biomedical Laboratories, 1999. 3. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"10-13 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. 4. VDRL Antigen Avoid contact with skin and eyes. Do not breathe mist. Wear suitable protective clothing. Keep container tightly closed. Keep away from sources of ignition. No smoking. 5. VDRL Test Control Serum Set | |||||||||||||||||||||||||||||
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.
