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Products

Rubella Test
Rubella IgM Serum Cassette

Catalog No.    Product Name            

ABT-FT-B210     Rubella IgM Serum Cassette

 

INTENDED USE

ACCU-TELL®Rapid Rubella IgM Test Cassette(Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to Rubella in serum or plasma to aid in the diagnosis of Rubella infection.

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid Rubella IgM Test Cassette (Serum/Plasma) was compared with leading commercial EIA Rubella tests; the results show that Rubella IgM Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

Method

 

EIA

 

Total

 

ACCU-TELL® Rapid Rubella Test

Results

Positive

 

Negative

Results

 

Positive

35

 

2

37

 

Cassette(Serum/Plasma)

 

 

Negative

1

 

356

357

 

 

 

 

Total Results

 

36

 

358

394

 

Relative Sensitivity: 97.2% (95%CI*: 86.5%-100%)

Relative Specificity: 99.4% (95%CI*: 98.0%-100%) Accuracy: 99.2% (95%CI*: 97.8%-99.8%)

*Confidence Intervals

 Precision

 Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive, and a high positive. The negative, low positive, and high 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 high positive. Three different lots of ACCU-TELL® Rapid Rubella IgM Test Cassette (Serum/Plasma) have been tested over a 3-day period using negative, low positive, and high positive specimens. The specimens were correctly identified >99% of the time.

 Cross-reactivity

ACCU-TELL® Rapid Rubella IgM Test Cassette (Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, RF, Syphilis, H. Pylori, CMV, TOXO, HSV 1/2 positive specimens. The results showed no cross-reactivity.

 Interfering Substances

ACCU-TELL® Rapid Rubella IgM Test Cassette (Serum/Plasma) has been tested and no interference was observed in specimens containing 110 mg/ml human albumin, 1 mg/ml bilirubin, 10 mg/ml hemoglobin, 0.2 mg/ml cholesterol and 15 mg/ml triglycerides. The following compounds have also been tested using ACCU-TELL® Rapid Rubella IgM Test Cassette (Serum/Plasma)  and no interference was observed.

Acetaminophen

Caffeine:

EDTA

Acetylsalicylic Acid

Gentisic Acid

Ethanol

Ascorbic Acid

Phenylpropanolamine

Glucose

Bilirubin: 1g/dL

Salicylic Acid

Phenothiazine

 

LIMITATIONS 

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

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

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

  4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of Rubella infection.