VIDAS ROTAVIRUS ASSAY
K965092 · Biomerieux Vitek, Inc. · LIQ · May 5, 1997 · Microbiology
Device Facts
| Record ID | K965092 |
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| Device Name | VIDAS ROTAVIRUS ASSAY |
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| Applicant | Biomerieux Vitek, Inc. |
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| Product Code | LIQ · Microbiology |
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| Decision Date | May 5, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 866.3405 |
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| Device Class | Class 1 |
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Intended Use
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.
Device Story
VIDAS RTV Assay; enzyme immunoassay (EIA) for qualitative detection of rotavirus antigen in stool specimens. Principle: Solid Phase Receptacle (SPR) coated with polyclonal anti-rotavirus VP6 antibody captures antigen; mouse monoclonal anti-rotavirus VP6 antibody conjugate acts as detector. Used in clinical laboratories; performed by trained personnel. Output: Qualitative test result (positive/negative/equivocal) based on test value relative to negative threshold. Aids clinical diagnosis of rotavirus infection.
Clinical Evidence
Clinical performance evaluated by comparing VIDAS RTV Assay to a commercial EIA with discrepancies resolved by a second EIA and EM. Study included 13 discrepant samples. Results: relative sensitivity 96.4%, relative specificity 95.1%, overall agreement 96.5%. Precision: intra-assay and inter-assay coefficients of variation <10%. Cross-reactivity/interference: no interference observed with ~50 enteric microorganisms. Limit of detection: 2.3 x 10^2 viral particles/ml.
Technological Characteristics
Enzyme immunoassay (EIA) using Solid Phase Receptacle (SPR) technology. Capture antibody: polyclonal anti-rotavirus VP6. Detector antibody: mouse monoclonal anti-rotavirus VP6 conjugate. Qualitative detection based on thresholding of test values.
Indications for Use
Indicated for the qualitative detection of rotavirus antigen in human stool specimens to aid in the diagnosis of rotavirus infection.
Regulatory Classification
Identification
Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.
Predicate Devices
- Cambridge Biotech Rotaclone Rotavirus Diagnostic Kit
Related Devices
- K972895 — VIDAS ROTAVIRUS (RTV) ASSAY · Biomerieux Vitek, Inc. · Oct 3, 1997
- K964424 — ROTAVIRUS EIA · Trinity Biotech, Inc. · Aug 8, 1997
- K990842 — SAS ROTA TEST · Sa Scientific, Inc. · Aug 9, 1999
- K971585 — IMMUNOCARD STAT! ROTAVIRUS · Meridian Diagnostics, Inc. · Aug 20, 1997
- DEN110001 — RIDASCREEN NOROVIRUS 3RD GENERATION EIA · R-Biopharm AG · Feb 23, 2011
Submission Summary (Full Text)
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K965092 MAY - 5 1997
# SUMMARY: Safety and Effectiveness Information for the VIDAS Rotavirus Assay
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens. It is substantially equivalent to the Cambridge Biotech Rotaclone Rotavirus Diagnostic Kit. Safety and effectiveness issues for qualitative antigen detection enzyme immunoassays such as the VIDAS RTV Assay may include the following:
1. False positive results: In studies comparing the VIDAS RTV Assay to one commercially available EIA with resolution of discrepancies by a second EIA, there were 7 false positive samples. This results in a relative specificity of 95.1%, with overall agreement of 96.5%.
2. False negative results: In studies comparing the VIDAS RTV Assay to one commercially available EIA with resolution of discrepancies by a second EIA, there were 6 false negative samples. This results in a relative sensitivity of 96.4%, with overall agreement of 96.5%.
3. The 13 discrepant samples were further tested with EM. Of the 13 discrepant results, 4 resolved positive and 4 resolved negative in agreement with VIDAS RTV. Three specimens were VIDAS positive and EIA negative, confirmed negative. One specimen was VIDAS negative and EIA positive, confirmed positive. One discrepant result was not tested. The overall agreement of all samples is 94.8%.
4. Equivocal results: In the studies done to support the VIDAS RTV Assay performance claims, there were 4 equivocal results when following package insert instructions.
5. Invalid results: In the studies done to support the VIDAS RTV Assay performance claims, there were no invalid results.
6. Cross-reactivity and interference: A panel of approximately 50 microorganisms representing normal enteric flora or common enteric pathogens was tested in the VIDAS RTV Assay. No cross-reactivity or interference was observed with the organisms tested.
7. Precision: In the studies done to support the VIDAS RTV Assay performance claims, the intra-assay precision testing showed coefficients of variation of less than 10%. The inter-assay precision testing gave coefficients of variation of less than 10%.
8. Assay specificity is conferred by the use of two anti-rotavirus antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
9. Limit of detection: The limit of detection is defined as the concentration of organism yielding a test value greater than the negative threshold. The results of testing known concentrations of rotavirus antigen (quantitated via EM) in the VIDAS RTV Assay showed the limit of detection to be approximately 2.3 x 10² viral particles/ml.
The VIDAS RTV Assay must be used according to package insert instructions when testing stool specimens for the presence of rotavirus antigen. Additional information and references may be found in the package insert.
