BIOMÉRIEUX
30211 047003 - 03 - 2022-07
VIDAS® TOXO Competition (TXC)
Intended Use
VIDAS® TOXO Competition is an automated qualitative test for use on the VIDAS® family instruments for the enzyme
immunoassay detection of anti‑Toxoplasma gondii total Ig in human serum or plasma (lithium heparin or EDTA) using the
ELFA technique (Enzyme Linked Fluorescent Assay).
Summary and Explanation
Toxoplasma gondii, an obligate intracellular protozoan parasite, is a significant pathogen among humans. The parasite,
whose primary host is the Felidae, is scattered in nature and invades all orders of mammals.
Toxoplasmosis is usually benign or asymptomatic, but can have severe consequences if it occurs in immunodeficient
subjects or fetuses.1 Congenital toxoplasmosis connected with maternal contamination prior to conception is exceptional
and most often occurs in immunocompromised women.2 Women who are seropositive before they become pregnant are
essentially protected from transmitting the infection to their unborn child. Women who are seronegative are at risk of
becoming infected during gestation.3
The diagnosis of Toxoplasma infection is most commonly made by biological examination: specific immunoglobulin
detection (IgM and IgG).4,5,6
VIDAS® TOXO Competition is a screening test designed to assess the immunity status of adult patients.7 If the test is
positive, seroconversion or acquired immunity should be determined using specific tests for the detection of IgG and IgM.
Principle
The assay principle combines an inhibition-competition enzyme immunoassay method with a final fluorescent detection
(ELFA).
The single-use Solid Phase Receptacle (SPR) serves as the solid phase as well as the pipetting device. Reagents for the
assay are ready-to-use and pre-dispensed in the sealed single-use reagent strips.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the
SPR device several times.
After dilution, the sample is incubated with the SPR device. Anti‑Toxoplasma antibodies (IgM and IgG) present in the
specimen will bind to the Toxoplasma gondi lysate proteins coating the interior of the SPR device.
Unbound components are eliminated during washing steps.
The solid phase is then incubated with the conjugate: alkaline phosphatase-labeled monoclonal anti‑P30 antibodies. This
conjugate will compete with the antibodies coated on the interior of the SPR device by the Toxoplasma antigen. Unbound
conjugate is removed by washing.
During the final detection step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR device.
The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the
fluorescence of which is measured at 450 nm.
The intensity of the fluorescence is inversely proportional to the concentration of immunoglobulins present in the sample.
At the end of the assay, the results are automatically calculated by the instrument and expressed as an index in relation
to the calibration curve stored in memory.
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Content of the Kit - (60 tests)
60 Strips (TXC)(a) STR Ready-to-use.
60 SPR devices (TXC) Ready-to-use.
2 x 30 SPR SPR devices coated with Toxoplasma gondii lysate proteins, RH Sabin strain
grown in mice.8
Standard (TXC) Ready-to-use.
1 x 1.8 mL S1 Human serum* containing anti‑Toxoplasma IgG + 1 g/L sodium azide and
protein stabilizers.
(liquid)
Positive Control (TXC) Ready-to-use.
1 x 1.9 mL Human serum* containing anti‑Toxoplasma IgG + 1 g/L sodium azide and
C1 protein stabilizers.
(liquid)
MLE data indicate the index: confidence interval ("Control C1 (+) Test Value
Range").
Negative control(b) Ready-to-use.
1 x 1.9 mL Phosphate buffer + protein stabilizer of animal origin + preservatives.
C2
(liquid) MLE data indicate the index: confidence interval ("Control C2 (-) Test Value
Range").
Specifications for the factory master data required to calibrate the assay: MLE barcode printed on the box label.
1 package insert downloadable from www.biomerieux.com
*This product has been tested and shown to be negative for HBs antigen, antibodies to HIV1, HIV2 and HCV. However,
since no existing test method can totally guarantee their absence, this product must be treated as potentially infectious.
Therefore, usual safety procedures should be observed when handling.
(a) DANGER H318 / P280 / P305 + P351 + P338
(b) WARNING EUH208 / H317 / P261 / P280 / P302 + P352
Hazard statements
• EUH208: Contains 2-methyl-2H-isothiazolin-3-one. May produce an allergic reaction.
• H317: May cause an allergic skin reaction.
• H318: Causes serious eye damage.
Precautionary statements
• P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
• P280: Wear protective gloves/protective clothing/eye protection/face protection.
• P302 + P352: IF ON SKIN: Wash with plenty of soap and water.
• P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
For further information, consult the Safety Data Sheet.
The SPR device
The interior of the SPR device is coated during production with Toxoplasma gondii lysate proteins. Each SPR device is
identified by the TXC code. Only remove the required number of SPR devices from the pouch and carefully reseal the
pouch after opening.
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The Reagent Strip
The strip consists of 10 wells covered with a labeled foil seal. The label comprises a barcode which mainly indicates the
assay code, kit lot number, and expiration date. The foil of the first well is perforated to facilitate the introduction of the
sample. The last well of each strip is a cuvette in which the fluorometric reading is performed. The wells in the center
section of the strip contain the various reagents required for the assay.
Description of the TXC strip
Well Reagents
1 Sample well.
2 Sample diluent: TRIS buffer (50 mmol/L) pH 7.3 - Polysorbate 20 + protein and chemical
stabilizers + 1 g/L sodium azide (400 µL).
3 Pre-wash solution: TRIS (50 mmol/L) pH 7.3 - Polysorbate 20 + protein and chemical stabilizers
+ 1 g/L sodium azide (600 µL)
4-5-7-8 Wash solution: TRIS (10 mmol/L) pH 7.3 - Polysorbate 20 + 1 g/L sodium azide (600 µL)
6 Conjugate: Alkaline phosphatase-labeled monoclonal anti-P30 antibodies (mouse) + 1 g/L
sodium azide (400 µL)
9 Empty well
10 Reading cuvette with substrate: 4‑Methyl‑umbelliferyl phosphate (0.6 mmol/L) + diethanolamine
(DEA) (0.62 mol/L or 6.6%, pH 9.2) + 1 g/L sodium azide (300 μL).
Reagents, Materials, and Disposables Required but Not Provided
• Pipette with disposable tip to dispense 125 µL.
• Powderless disposable gloves.
• For other specific materials and disposables, please refer to the Instrument User Manual.
• Instruments of the VIDAS® family.
Warnings and Precautions
• For in vitro diagnostic use only.
• For professional use only.
• This kit contains products of human origin. No known analysis method can totally guarantee the absence of
transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially
infectious and handled observing the usual safety precautions (see Laboratory Biosafety Manual - WHO -
Geneva - latest edition).
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does
not totally guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these
products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest; do
not inhale).
• Do not use reagents after the expiration date indicated on the box label.
• Do not mix reagents (or disposables) from different lots.
• Do not use the SPR devices if the pouch is pierced or if the dot sealing a SPR device has come unstuck.
• Do not use visibly deteriorated strips (damaged foil or plastic).
• Use powderless gloves, as powder has been reported to cause false results for certain enzyme immunoassay tests.
• Kit reagents contain sodium azide which can react with lead or copper plumbing to form explosive metal azides. If
any liquid containing sodium azide is disposed of in the plumbing system, drains should be flushed with water to
avoid build-up.
• Refer to the hazard statements “H” and precautionary statements “P” indicated above.
• Spills should be wiped up thoroughly after treatment with liquid detergent or a solution of household bleach
containing at least 0.5% sodium hypochlorite. See the User Manual for cleaning spills on or in the instrument. Do not
autoclave solutions containing bleach.
• The instrument should be regularly cleaned and decontaminated (refer to the User Manual for user and preventive
maintenance operations).
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Storage Conditions
• Store the kit at +2°C/+8°C.
• Do not freeze reagents.
• Store all unused reagents at +2°C/+8°C.
• After opening the kit, check that the SPR pouch is correctly sealed and undamaged. If not, do not use the SPR
devices.
• After use, carefully reseal the pouch with the desiccant inside to maintain stability of the SPR devices, and
return the complete kit to +2°C/+8°C.
• If stored according to the recommended conditions, all components are stable until the expiration date indicated on
the box label.
Samples
Specimen type and collection
Human serum or plasma (lithium heparin or EDTA).
It is recommended that each laboratory checks the compatibility of collection tubes used. Sera can be inactivated before
testing (30 minutes at +56°C).
Sample stability
Samples may be freshly collected or stored in stoppered tubes for 5 days at +2°C/+8°C after which time the sera or
plasma must be frozen at -31°C/-19°C.
Avoid successive freezing and thawing.
A study performed on frozen samples over a period of 2 months, showed that the quality of results is not affected.
Sample-related interference
It is recommended not to use hemolyzed, lipemic, icteric or inactivated samples, and, if possible, to collect a new sample.
Refer to the section PERFORMANCE – Study of drugs and other potentially interfering substances for the
compounds tested.
Instructions for Use
For complete instructions, see the Instrument User Manual.
Reading MLE data
When opening a new lot of reagents
With the external instrument barcode reader, scan the MLE data on the box label before performing the test. If this
operation is not performed before initiating the tests, the instrument will not be able to print results.
Note: The master lot data need only be entered once for each lot.
It is possible to enter MLE data manually or automatically depending on the instrument (refer to the User Manual).
Calibration
Calibration, using the standard provided in the kit, must be performed each time a new lot of reagents is opened, after
the MLE data have been entered, and then every 14 days.
This operation provides instrument-specific calibration curves and compensates for possible minor variations in assay
signal throughout the shelf life of the kit.
The standard, identified by S1, must be tested in duplicate. The standard value must be within the set RFV (Relative
Fluorescence Value) range indicated in the MLE data. If this is not the case, recalibrate.
Procedure
1. Only remove the required reagents from the refrigerator and allow them to come to room temperature for at least
30 minutes.
2. Use one "TXC" strip and one "TXC" SPR device for each sample, control, or standard to be tested. Make sure the
SPR pouch has been carefully resealed after the required SPR devices have been removed.
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3. The test is identified by the "TXC" code on the instrument. The standard, identified by S1, must be tested in duplicate.
If the positive control is to be tested, it should be identified by "C1". If the negative control needs to be tested, it
should be identified by "C2".
4. Mix the standard, controls and samples using a vortex-type mixer (for serum or plasma separated from the pellet).
5. For this test, the standard, control, and sample test portion is 125 µL.
6. Insert the "TXC" SPR devices and "TXC" strips into the instrument. Check to make sure the color labels with the
assay code on the SPR devices and the Reagent Strips match.
7. Initiate the assay as directed in the User Manual. All the assay steps are performed automatically by the instrument.
8. Close the vials and return them to +2°C/+8°C after pipetting.
9. The assay will be completed within approximately 40 minutes. After the assay is completed, remove the SPR
devices and strips from the instrument.
10. Dispose of the used SPR devices and strips into an appropriate recipient.
Results and Interpretation
Once the assay is completed, results are analyzed automatically by the computer. Fluorescence is measured twice in the
Reagent Strip’s reading cuvette for each sample tested. The first reading is a background reading of the substrate
cuvette before the SPR device is introduced into the substrate.
The second reading is taken after incubating the substrate with the enzyme bound to the interior of the SPR. The RFV
(Relative Fluorescence Value) is calculated by subtracting the background reading from the final result. This calculation
appears on the result sheet.
The instrument calculates a test value for each sample. This value is the ratio between the test's RFV (Relative
Fluorescence Value) and the standard stored in memory.
Threshold and interpretation of results
Test Value Interpretation
i ≥ 1.6 Negative
i < 1.6 Positive
If the result is negative, the patient is not immunized and there is no seroconversion.
If the result is positive, it is recommended that the same sample, or another sample taken 21 days later be tested using
specific tests (for IgG and IgM detection) to determine whether the result is a seroconversion or an established immunity.
Interpretation of test results should be made taking into consideration the patient's clinical history, and the results of any
other tests performed.
The VIDAS® TOXO Competition reagent is calibrated against collection sera.
Quality Control
One positive control and one negative control are included in each kit.
These controls must be performed immediately after opening a new kit to ensure that reagent performance has not been
altered. Each calibration must also be checked using these controls. The instrument will only be able to check the control
values if they are identified by C1 and C2.
Results cannot be validated if the control value deviates from the expected values.
The expected negative control value must be included in the range indicated on the MLE card.
Note: It is the responsibility of the user to perform Quality Control in accordance with any applicable local regulations.
Limitations of the Method
• Interference may be encountered with certain sera containing antibodies directed against reagent components. For
this reason, assay results should be interpreted taking into consideration the patient's clinical history and the results
of any other tests performed.
• VIDAS® TOXO Competition has not been validated for use with neonatal specimens nor cord blood.
VIDAS® TOXO Competition has not been validated for use with specimens other than human serum or plasma.
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• VIDAS® TOXO Competition is not intended to be used for the detection of the presence of, or exposure to, a
transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to
assess their suitability for transfusion, transplantation or cell administration.
Performance
Studies performed using the VIDAS® TOXO Competition assay gave the following results:
Sensitivity and Specificity
Clinical performance was calculated according to CLSI EP12‑A2 recommendations.
A sensitivity study and a specificity study were performed on different populations consistent with the target populations
of VIDAS® TOXO Competition (patients from the laboratory routine, pregnant women, immunocompromised subjects,
subjects with congenital toxoplasmosis, and seroconversion). Nine hundred and eight (908) samples were collected and
tested at two French sites.
The results obtained with VIDAS® TOXO Competition were compared to the sample status given by two reference
techniques (ISAGA and Direct Sensitized Agglutination). A sample was considered:
• Positive when at least one of the two techniques had a positive or equivocal result,
• Negative when both techniques had negative results.
A prevalence of 50% was used to calculate the predictive values.
The sensitivity, the specificity, and the predictive values were calculated along with 95% CI (Confidence Interval) and
reported in the following table.
Sample status (2/2 rule)
Positive Negative Total
®
VIDAS TOXO Positive 472 4 476
Competition Negative 4 428 432
Total 476 432 908
Performance % 95% CI
Sensitivity 99.16% [ 97.86 ; 99.77 ]%
Specificity 99.07% [ 97.65 ; 99.75 ]%
Positive Predictive Value (PPV) 99.07% [97.58% ; 99.65%]
Negative Predictive Value (NPV) 99.16% [97.80% ; 99.68%]
Seroconversion panel
One hundred and ten (110) serum samples distributed in 31 panels from women patients followed up over time for
seroconversion were tested. The results obtained with VIDAS® TOXO Competition were compared to the sample status
given by two reference techniques (ISAGA and Direct Sensitized Agglutination) as described in the Sensitivity and
Specificity part.
For 30 panels among the 31, results were concordant between VIDAS® TOXO Competition and the sample status: either
samples were positive since the first time-point or seroconversion was detected at the same time-point.
For one panel, the sample status switched from negative to positive on the third measurement (over five) whereas, with
VIDAS® TOXO Competition, it was found positive from the fourth measurement.
Precision
Within-Run Reproducibility:
Three samples were tested in a same run.
n Mean RFV CV (%)
Negative 30 2215 2.8
Weakly positive 26 1700 2.5
Strongly positive 27 118 6.2
Between-Run Reproducibility:
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Three samples were tested singly in 17 different runs on the same VIDAS® instrument.
Mean RFV CV (%)
Negative 2217 4.4
Weakly positive 1706 3.7
Strongly positive 1044 4.6
Cross Reactivity and Relevant Interferents
Number of interfering samples / Number of interfering samples /
Number of T. gondii positive samples Number of T. gondii negative samples
tested according to reference tested according to reference
techniques techniques
HBs Antigen + 0/9 0/2
HIV antibodies 0/10 0/4
Plasmodium falciparum 0/6 0/4
CMV IgM + 0/7 0/1
Anti-nuclear antibodies 0/7 0/16
EBV antibodies 0/2 2/18
Lyme antibodies 0/2 0/2
Multiparous pregnant women 0/8 0/13
Chlamydia trachomatis 0/7 0/0
Rheumatoid factor 0/0 1/4
Syphilis antibodies 0/4 0/0
Total 0/62 3/64
No interference linked to the presence of these potential interferents was revealed, except for two EB‑positive samples
and one sample with rheumatoid factor which gave false positive results with VIDAS® TOXO Competition.
Study of drugs and other potentially interfering substances
Potential interference by commonly used drugs and other substances was studied according to CLSI EP07‑Ed3
recommendations. No significant interference was detected up to the maximum concentrations indicated below:
Tested substance Maximum concentration
Hemoglobin 10 g/L (620 µmol/L)
Unconjugated bilirubin 0.4 g/L (684 µmol/L)
Conjugated bilirubin 0.4 g/L (475 µmol/L)
Triglycerides 30 g/L
Human Albumin 60 g/L
Prevalence
T. gondii is a strict pathogen whose prevalence differs from one country to another or even one region to another.
Contamination by T. gondii can vary according to cultural customs and eating habits, resulting in a prevalence ranging
from less than 10% in certain regions of Northern Europe to more than 90% in Africa.
Waste Disposal
Dispose of used or unused reagents, as well as any other contaminated disposable materials, following procedures for
infectious or potentially infectious products.
It is the responsibility of each laboratory to handle waste and effluents produced, according to their nature and degree of
hazardousness, and to treat and dispose of them (or have them treated and disposed of) in accordance with any
applicable regulations.
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Literature References
1. FORTIER B., AJANA F., CAMUS D. - Prévention, diagnostic et suivi de la toxoplasmose congénitale - NPN Médecine
1991;65:259‑264
2. DESMONTS G., COUVREUR J. THUILLIEZ P. – Toxoplasmoses congénitales. Cinq cas de transmission à l’enfant
d’une infection maternelle antérieure à la grossesse – Press. Méd. 1990;19:1445‑9.
3. Bertrand LECOLIER - Séroconversion de la toxoplasmose - Tempo Médical 422-20/03/91- 13‑15.
4. POULETTY P., PINON J.M., GARCIA GONZALEZ M., DESMONTS G., THULLIEZ P., THOANNES H., KADOUCHE
J. - An Anti-Human Immunoglobuline M Monoclonal Antibody for Detection of Antibodies to Toxoplasma gondii - Eur.
J. Clin. Microbiology 1984;3:510‑515.
5. SANTORO F., AFCHAIN D, PIERCE R., CESBRON J. Y., OVLAQUE G., CAPRON A. - Serodiagnosis of Toxoplasma
infection using a purified parasite protein (P30) - Clin. Exp.Immunol. 1985;62:262‑269.
6. NAOT Y., REMINGTON, J.S. - An Enzyme-Linked Immunosorbent Assay for Detection of IgM Antibodies to
Toxoplasma gondii: Use for Diagnosis of Acute Acquired Toxoplasmosis - J Infect Dis. 1980;142:757‑766.
7. DAVE J., BALFOUR A.H., and PERKIN J. - Evaluation of the VIDAS toxo competition assay for the detection of
antibodies to Toxoplasma gondii in human sera - Serodiagnosis Immunotherapy Infectious Disease 1994;6:41‑45.
8. COUZINEAU P. and BAUFINE-DUCROCQ H. - Study of the possibilities of utilization of TG 180 sarcoma of the
mouse. Application to toxoplasmosis - Ann. Parasitol. Hum. Comp. 1969;44:217‑224.
Index of Symbols
Symbol Meaning
Catalogue number
In Vitro Diagnostic Medical Device
Manufacturer
Temperature limit
Use by date
Batch code
Consult Instructions for Use
Contains sufficient for <n> tests
Date of manufacture
Limited Warranty
bioMérieux warrants the performance of the product for its stated intended use provided that all procedures for usage,
storage and handling, shelf life (when applicable), and precautions are strictly followed as detailed in the instructions for
use (IFU).
Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any implied warranties of
merchantability and fitness for a particular purpose or use, and disclaims all liability, whether direct, indirect or
consequential, for any use of the reagent, software, instrument and disposables (the "System") other than as set forth in
the IFU.
Revision History
Change type categories
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N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the revision
history.
Release Date Part Number Change Type Change Summary
2017/01 06361R Technical change Content of the Kit - (60 tests)
2019-08 047003-02 Administrative Limited Warranty
Technical change Content of the Kit - (60 tests)
Warnings and Precautions
2022-07 047003-03 Administrative Formatting and wording changes.
Content of the Kit / Literature References
Technical change Summary and Explanation / Content of the Kit /
Samples / Limitations of the Method / Performance
BIOMÉRIEUX, the BIOMÉRIEUX logo, SPR and VIDAS are used, pending, and/or registered trademarks belonging to
bioMérieux, or one of its subsidiaries or one of its companies
Any other name or trademark is the property of its respective owner.
For users in the European Union (Regulation (EU) 2017/746) and in countries with similar requirements: Should a
serious incident occur during the use of this device or as a result of its use, please report it to the manufacturer and/or
their authorized representative as well as to your national authority.
SSP (Summary of Safety and Performance) location after the launch of the European Database on Medical Devices/
Eudamed: https://ec.europa.eu/tools/eudamed.
673 620 399 RCS LYON
Tel. 33 (0)4 78 87 20 00
bioMérieux SA Fax 33 (0)4 78 87 20 90
376 Chemin de l'Orme www.biomerieux.com
69280 Marcy-l’Etoile - France
