Accu-Tell® TOXO IgM Rapid Test Cassette (Serum/Plasma)

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Accu-Tell® TOXO IgM Rapid Test Cassette (Serum/Plasma)

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Accu-Tell® TOXO IgM Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) in human serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii.
Product Description

Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
TOXO IgM Cassette Serum/PlasmaABT-FT-B9125T


KEY POINTS

Detection for: IgM anti-Toxoplasma Gondii (T. gondii) in human serum or plasma.

Reading time: 15 minutes.

Relative Sensitivity: 92.6%

Relative Specificity: 99.5%

Accuracy: 98.8%

 

INTRODUCTION

T. gondii is an obligate intracellular protozoan parasite with a worldwide distribution. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism.

 

INTENDED USE

ACCU-TELL® TOXO IgM Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) in human serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with ACCU-TELL® TOXO IgM Cassette (Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

 

TEST PROCEDURE

Toxo IgM Rapid Test 3.JPG

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and draw the serum/plasma up to the Fill Line as shown in illustration below (approximately 10 μl ) and 2 drops of buffer (approx. 80μl) to the specimen well of the test cassette. Avoid trapping air bubbles in the specimen well. See the illustration below.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

A clinical evaluation was conducted comparing the results obtained using ACCU-TELL® TOXO IgM Cassette (Serum/Plasma) to TOXO IgM ELISA Testing.

IgM Results

MethodT.Gondii ELISA   (IgM)Total Results
ACCU-TELL® TOXO IgM Cassette (Serum/Plasma)ResultsPositiveNegative
Positive25126
Negative2219221
Total Results27220247

Sensitivity: 92.6% (95%CI: 75.7%-99.1%)*

Specificity: 99.5% (95%CI: 97.5%~99.9%)*

Accuracy: 98.8% (95%CI: 96.5%~99.7%)*

*Confidence interval

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of four specimens: a negative, a low positive, a middle positive and a high positive. The negative, low positive, a middle positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the specimens: a negative, a low positive, a middle positive and a high positive. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® TOXO IgM Cassette (Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, Syphilis, HEV, H. Pylori, HAMA, RF, MONO, HSV, CMV and Rubella positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to TOXO negative and positive specimens.

Ascorbic Acid:  20mg/ml         

Hemoglobin: 1000mg/dl         

Gentisic Acid: 20 mg/dL

Oxalic Acid: 60mg/dL              

Bilirubin: 1000mg/dL               

Uric acid: 20mg/ml

Acetaminophen:  20 mg/dL     

Aspirin: 20mg/dl                     

Methanol: 10%

Creatine: 200mg/dl                 

Albumin: 2 g/dL                      

Caffeine: 20 mg/dL

None of the substances at the concentration tested interfered in the assay.

  

LIMITATIONS

1. The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to T.gondii in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

2. ACCU-TELL® TOXO IgM Cassette (Serum/Plasma) is limited to the qualitative detection of the antibodies to T.gondii in human serum or plasma. The intensity of the test band does not linear correlation with the antibody titer in the specimen.

3. A negative result for an individual subject indicates absence of detectable T. gondii antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with T. gondii

4. A negative result can occur if the quantity of the T. gondii antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected

5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.

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