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Products

Rubella Test
Rubella IgG/IgM Whole Blood Cassette

Catalog No.       Product Name

ABT-FT-B227     Rubella IgG/IgM  Whole Blood Cassette

INTENDED USE

Accu-Tell® Rapid Rubella IgG/IgM Test Cassette(Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Rubella in whole blood, serum or plasma to aid in the diagnosis of Rubella infection.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

Method

Rubella EIA (IgM)

Total Results

AccuTell®

Rapid Rubella IgM Test

Cassette

Results

Positive

Negative

Positive

35

2

37

Negative

1

356

357

Total Results

36

358

394

Relative Sensitivity: 97.2% (95%CI*: 85.5%-100%)

*Confidence Interval

Relative Specificity: 99.4% (95%CI*: 98.0%-100%)

Accuracy: 99.2% (95%CI*: 97.8%-99.8%)

Method

Rubella EIA (IgG)

Total Results

AccuTell®

Rapid Rubella IgG Test

Cassette

Results

Positive

Negative

Positive

59

1

60

Negative

2

309

311

Total Results

61

310

371

Relative Sensitivity: 96.7% (95%CI*: 88.7%-99.6%)

*Confidence Interval

Relative Specificity: 99.7% (95%CI*: 98.2%-99.9%)

Accuracy: 99.2% (95%CI*: 97.7%-99.8%)

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 IgG/IgM Test Cassette (Whole Blood/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 IgG/IgM Test Cassette (Whole Blood/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 IgG/IgM Test Cassette (Whole Blood/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 IgG/IgM Test Cassette (Whole Blood/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 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of IgM and IgG antibodies to Rubella in whole blood, serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgM and IgG antibodies to Rubella can be determined by this qualitative test.

  2. Accu-Tell® Rapid Rubella IgG/IgM Rapid Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of IgM or IgG 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.