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

Product Description

CATALOG

KEY POINTS

Detection for: Anti-TB antibodies (Isotypes IgG, IgM and IgA) in serum or plasma

Specimen volume: 75μL Serum or Plasma Specimen;

Reading time: 10 minutes

Relative Sensitivity: 83.8% (95%CI*: 75.3%~90.3%);

Relative Specificity: 98.8% (95%CI*: 97.2%~99.6%);

Relative Accuracy: 95.7% (95%CI*: 93.6%~97.3%).

INTRODUCTION

Tuberculosis (TB) is spread primarily via airborne transmission of aerosolized droplets developed by coughing, sneezing and talking. Areas of poor ventilation pose the greatest risk of exposure to infection. TB is a major cause of morbidity and mortality worldwide, resulting in the greatest number of deaths due to a single infectious agent.

INTENDED USE

ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in serum or plasma specimens.

TEST PROCEDURE

1.  Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2.  Place the cassette on a clean and level surface.

For Serum or Plasma Specimens:

Hold the dropper vertically, transfer 3 drops of serum or plasma (approximately 75μL) to the specimen well (S) of test cassette and then start the timer. See illustration below.

3.  Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 30 minutes.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) has been calibrated against specimens that have been collected from individuals found to be either smear positive/negative or culture positive/negative. The results show that the relative sensitivity of ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) is 83.8%, the relative specificity is 98.8 % and the relative accuracy is 95.7%.

ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) vs. Smear/Culture

Relative Sensitivity: 88/105=83.8% (95%CI*: 75.3%~90.3%);

Relative Specificity: 405/410=98.8% (95%CI*: 97.2%~99.6%);

Relative Accuracy: (88+405)/(88+17+5+405)=493/515=95.7% (95%CI*: 93.6%~97.3%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 20 replicates of four specimens: a negative, a low positive, a middle positive and a high positive. The negative, low positive, middle positive, high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 5 independent assays on the same four specimens: The negative, low positive, middle positive, high positive values. Three different lots of ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) have been tested using negative, low positive, middle positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-Reactivity

ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) has been tested with specimens positive for: anti-HIV, pulmonary diseases, anti-CMV, Rheumatoid factor (RF), anti-HCV and specimens from children below 15 years, who have been administered BCG vaccine. No cross-reactivity was observed, indicating that the performance of ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) is stable in presence of these factors.

Interfering Substances

ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens, as well as serum specimens containing high bilirubin levels. Results indicate that no interference was observed in specimens containing up to 500 mg/dL hemoglobin; up to 30 mg/dL bilirubin; and up to 2,000 mg/dL human serum albumin.

LIMITATIONS

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

2. ACCU-TELL^® TB Rapid Test Cassette (Serum/Plasma) will only indicate the presence of anti-TB antibodies in the specimen and should not be used as the sole criteria for the diagnosis of active tuberculosis diagnosis.

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

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