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

Product Description

CATALOG

KEY POINTS

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

Specimen volume: 75μL Serum or Plasma Specimen;

                                 75μL Fingerstick or Venipuncture Whole Blood 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.

INTENDED USE

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

TEST PROCEDURE

1. Remove the test strip 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.

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 .

For Venipuncture Whole Blood Specimens:

Hold the dropper vertically and transfer 3 drops of venipuncture whole blood (approximately 75 μL) to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration .

For Fingerstick Whole Blood Specimens:

Allow 3 hanging drops of fingerstick whole blood (approximately 75μL) to fall into the center of the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration .

2. 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 (Whole Blood/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 (Whole Blood/Serum/Plasma) is 83.8%, the relative specificity is 98.8 % and the relative accuracy is 95.7%.

ACCU-TELL^® TB Rapid Test Strip/Cassette (Whole Blood/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 (Whole Blood/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 (Whole Blood/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 (Whole Blood/Serum/Plasma) is stable in presence of these factors.

Interfering Substances

ACCU-TELL^® TB Rapid Test Cassette (Whole Blood/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 500mg/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 (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of anti-TB antibodies in whole blood, 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 (Whole Blood/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.