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

Product Description

CATALOG

KEY POINTS

Detection for: IgM antibodies to Rubella in serum or plasma

Reading time: 15 minutes

Relative Sensitivity: 100%

Relative Specificity: 95.6%

Accuracy: 96.2 %

INTRODUCTION

Rubella virus is a member of the Togaviridae family, found mainly in human populations. Generally rubella is considered a mild adolescence disease. However a maternal infection could be transmitted through the placenta to the fetus, causing congenital rubella. Primary rubella infection contracted during early pregnancy, may have severe consequences as severe fetal damage, stillbirth or abortion.

INTENDED USE

ACCU-TELL^® Rubella IgM Rapid 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.

TEST PROCEDURE

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 above.

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

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

Sensitivity: 100% (95%CI*:90.5%~100.0%)

Specificity: 95.6% (95%CI*: 91.8%~98.0%)

Accuracy: 96.2 %( 95%CI*: 92.9%~98.2%)

*Confidence Interval

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of the 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 and a high positive. The specimens were correctly identified >99% of the time.

Cross-reactivity

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

Interfering Substances

The following compounds have also been tested using ACCU-TELL^® Rubella IgM Rapid Test Cassette (Serum/Plasma) and no interference was observed.

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

LIMITATIONS

1. ACCU-TELL^® Rubella IgM Rapid 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^® Rubella IgM Rapid 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.

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