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Products

MONO Test
MONO Serum/Plasma Test Cassette

Catalog No.          Product Name

ABT-IDT-B257        MONO Serum/Plasma Test Cassette

 

INTENDED USE

ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in serum or plasma as an aid in the diagnosis of Infectious Mononucleosis.


PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) has been evaluated with specimens confirmed positive or negative by a leading commercial slide agglutination test. The slide agglutination test served as the reference method for ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) The result shows that the sensitivity of ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) is >99.9% relative to the slide agglutination test.

Specificity

ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) uses an antigen that is highly specific for IM antibodies in serum or plasma. The results show that the specificity of ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma is 98.9% relative to the slide agglutination test.

MONO Rapid Test Cassette vs. Slide Agglutination

Method

Slide Agglutination

Total Results

ACCU-TELL® Rapid MONO Test Cassette

Results

Positive

Negative

Positive

60

1

61

Negative

0

89

89

Total Results

60

90

150

Relative Sensitivity: >99.9% (95.1%-100.0%)*        

Relative Specificity: 98.9% (94.0%-99.9%)*

Relative Accuracy: 99.3% (96.3%-99.9%)*

* 95% Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 3 replicates of three specimens: a negative, a low positive and a middle positive. The negative, low positive and middle positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same three specimens: a negative, a low positive and a middle positive. Three different lots of ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) have been tested using negative, low positive and middle positive specimens. The specimens were correctly identified >99% of the time.

Cross-Reactivity

RF, HBsAg, HBeAg, HBcAb, HBeAb, HCV, TB, HIV and Syphilis positive specimens were tested with ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma). No cross-reactivity was observed, indicating that ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) has a high degree of specificity for human antibodies to IM.

LIMITATIONS

  1. ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of Infectious Mononucleosis antibodies in serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Infectious Mononucleosis antibody concentration can be determined by this qualitative test.

  2. ACCU-TELL® Rapid MONO Test Cassette (Serum/Plasma) will only indicate the presence of Infectious Mononucleosis antibodies in the specimen and should not be used as the sole criteria for the diagnosis of Infectious Mononucleosis infection.

  3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

  4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Infectious Mononucleosis infection.