COPALIS TORC TOTAL ANTIBODY ASSAY

K970931 · Sienna Biotech, Inc. · LQN · Apr 24, 1997 · Microbiology

Device Facts

• Record ID: K970931
• Device Name: COPALIS TORC TOTAL ANTIBODY ASSAY
• Applicant: Sienna Biotech, Inc.
• Product Code: LQN · Microbiology
• Decision Date: Apr 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Device Story

Copalis TORC Total Antibody Assay utilizes Coupled Particle Light Scattering (Copalis) technology for immunoassay. Input: human serum sample. Principle: antibody-dependent particle aggregation; latex microparticles coated with inactivated T. gondii, rubella, and CMV antigens aggregate when specific antibodies are present. System agitates sample for 10 minutes; detector measures changes in light scattering by discriminating particle sizes and counting reacted vs. unreacted particles. Output: qualitative antibody detection based on aggregation levels relative to cutoff. Used in physician office laboratories (POLs) or clinical settings; operated by laboratory personnel. Results assist clinicians in determining patient immune status or immunological experience and identifying recent infection via seroconversion.

Clinical Evidence

Clinical testing compared Copalis TORC to Abbott IMx assays using 250 serum samples. T. gondii: 91.4% sensitivity, 98.6% specificity. Rubella: 98.7% sensitivity, 100% specificity. CMV: 94.4% sensitivity, 100% specificity. POL proficiency study (3 sites, 4 operators) showed 100% agreement with expected results. Reproducibility assessed via 14-member blinded panel and duplicate testing; total %CV ranged from 2.3% to 15.8% across analytes.

Technological Characteristics

Uses Coupled Particle Light Scattering (Copalis) technology. Employs latex microparticles coated with inactivated T. gondii, rubella, and CMV antigens. Detection system measures light scattering changes via particle size discrimination and counting. System is designed for use with the Copalis One Immunoassay System.

Indications for Use

Indicated for qualitative detection of total IgG and IgM antibodies to Toxoplasma gondii, rubella, and CMV in human serum to determine immune status or immunological experience. Used to demonstrate seroconversion in paired sera. Not for blood/plasma donor screening.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

Predicate Devices

• Abbott IMx Toxo IgG 2.0
• Abbott IMx Rubella IgG 2.0
• Abbott IMx CMV IgG

Submission Summary (Full Text)

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K970931
March 6, 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:
Judith J. Smith
Sienna Biotech, Inc.
9115 Guilford Rd. Suite 180
Columbia, MD 21046

APR 24 1997

## NAME OF DEVICES:

Trade Name: Copalis TORC Total Antibody Assay

Common Names/Descriptions: Immunoassay for the Detection of Total Antibodies to Toxoplasma gondii, Rubella and Cytomegalovirus

Classification Names: Toxoplasma gondii serological reagents; Rubella virus serological reagents; Cytomegalovirus serological reagents

## PREDICATE DEVICES:

Abbott IMx Toxo IgG 2.0, Rubella IgG 2.0, CMV IgG

## DEVICE DESCRIPTION:

INTENDED USE: The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or protozoal pathogens.

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SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

The Copalis TORC Total Antibody Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to *Toxoplasma gondii*, rubella and CMV using a single reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated *Toxoplasma gondii*, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.

## PERFORMANCE DATA:

**Clinical Sample Testing:** Clinical sample testing was conducted at Sienna Biotech laboratory to evaluate the performance of the Copalis TORC Total Antibody Assay (TORC) compared to the corresponding Abbott IMx assays.

A total of 250 serum samples were tested. In initial testing, relative sensitivity of the *Toxoplasma gondii* antibody component of the assay was 91.4%; relative specificity was 98.6%. Relative sensitivity of the rubella antibody component of the assay was 98.7%; relative specificity was 100%. Relative sensitivity of the CMV antibody component of the assay was 94.4%; relative specificity was 100%.

**Physician Office Laboratory (POL) Proficiency Study:**

A study was conducted at 3 POL sites to evaluate the proficiency and reproducibility of different operators with the Copalis TORC Total Antibody Assay (TORC). The 3 sites represented POLs ranging from small to large group practices; 4 operators participated in the study, representing high school to 4-year educational levels.

A 14-member blinded proficiency panel was tested by each operator in each of three runs. Proficiency among operators was determined by comparison of Copalis TORC assay results for each panel member with the “expected” results as established by in-house testing on a comparator assay. The study showed 100% agreement between Copalis results from all operators and expected results.

Reproducibility was determined based on the 7 samples run in duplicate within each run. Within-run and total percent coefficient of variation (%CV) were calculated among operators for each sample. See the following table for a summary of %CV ranges.

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# SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

Physician Office Laboratory Reproducibility;
Total Precision - All Sites, All Operators

| SAMPLE | RANGE | TOXO | RUBELLA | CMV |
| --- | --- | --- | --- | --- |
| #1 | CTR | 131 | 190 | 215 |
| | WITHIN-RUN %CV | 5.9 | 6.0 | 11.9 |
| | TOTAL %CV | 7.7 | 8.2 | 13.9 |
| #2 | CTR | 151 | 189 | 100 |
| | WITHIN-RUN %CV | 6.7 | 7.9 | 2.4 |
| | TOTAL %CV | 9.0 | 7.6 | 2.4 |
| #3 | CTR | 134 | 188 | 127 |
| | WITHIN-RUN %CV | 6.6 | 9.5 | 6.5 |
| | TOTAL %CV | 8.0 | 8.3 | 6.0 |
| #4 | CTR | 101 | 201 | 223 |
| | WITHIN-RUN %CV | 1.5 | 6.0 | 6.3 |
| | TOTAL %CV | 2.3 | 7.4 | 13.2 |
| #5 | CTR | 101 | 150 | 101 |
| | WITHIN-RUN %CV | 1.7 | 5.2 | 2.1 |
| | TOTAL %CV | 2.3 | 5.4 | 2.8 |
| #6 | CTR | 100 | 133 | 250 |
| | WITHIN-RUN %CV | 1.6 | 4.1 | 8.2 |
| | TOTAL %CV | 2.4 | 6.7 | 15.8 |
| #7 | CTR | 101 | 141 | 140 |
| | WITHIN-RUN %CV | 1.0 | 3.6 | 2.2 |
| | TOTAL %CV | 2.5 | 7.0 | 7.5 |