Accu-Tell^® Chikungunya IgG/IgM Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgG and/or IgM to Chikungunya (CHIK) in whole blood, serum or plasma；

Reading time: 15 minutes；

Relative Sensitivity: >=99.9%；

Relative Specificity: >=99.9%

Accuracy: >=99.9%

INTRODUCTION

Chikungunya is a rare viral infection transmitted by the bite of an infected Aedes aegyptimosquito. It is characterized by a rash, fever and severe joint pain (arthralgias) that usually lasts for three to seven days. The name is derived from the Makonde and meaning “that which bends up” in reference to the stooped posture developed as a result of the arthritic symptoms of the disease. It occurs during the rainy season in tropical areas of the world, primarily in Africa, South-East Asia, southern India and Pakistan.

INTENDED USE

ACCU-TELL^® Chikungunya IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and/or IgM to Chikungunya (CHIK) in whole blood, serum or plasma to aid in the diagnosis of Chikungunya infection.

TEST PROCEDURE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

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 cassette on a clean and level surface.

For Serum or Plasma specimen:

3. Hold the dropper vertically and transfer 1 drop serum or plasma (approximately 40 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL),and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

3. Hold the dropper vertically and transfer 1 drop whole blood (approximately 40 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

3. To use a capillary tube: Fill the capillary tube and transfer approximately 40 μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

4. Wait for the colored line(s) to appear. Read results at 15 minutes. Positive results can be visible in as soon as 1 minute. Do not interpret the result after 15 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

The evaluation specimen panel consisted of 10 specimens from recently infected individuals diagnosed by leading commercial test, 6 specimens from infected individuals and 126 negative specimens. The evaluation data are shown in the following table.

Relative sensitivity: (6+10)/ (6+10)>=99.9% (95%CI*: 82.9%~100.0%);

Relative specificity: 126/126>=99.9% (95%CI*: 97.7%~100.0%);

Accuracy: (6+10+126)/ (6+10+126)>=99.9% (95%CI*: 97.9%~100.0%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of four specimens: a negative, an IgG positive and an IgM positive. The negative, an IgG positive and an IgM positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same three specimens: a negative, an IgG positive and an IgM positive. Three different lots of the Chikungunya IgG/IgM Combo Test Cassette (Whole Blood/Serum/Plasma) have been tested over a 3-day period using a negative, an IgG positive and an IgM positive specimen. The specimens were correctly identified >99% of the time.

LIMITATIONS

1. The Assay Procedure and the interpretation of Assay Result sections must be followed closely when testing for the presence of presence of IgG and/or IgM anti-CHIK in serum, plasma or whole blood from individual subjects. Failure to follow the procedure may give inaccurate results.

2. ACCU-TELL^® Chikungunya IgG/IgM Combo Rapid Test is limited to the quantitative detection of IgG and IgM anti-CHIK in human serum, plasma or whole blood. The intensity of the test line does not have a linear correlation with the antibody titer in the specimen.

3. A negative result for an individual subject individual absence of detectable IgG and IgM anti-CHIK. However, a negative test result does not preclude the possibility of exposure to or infection CHIK.

4. A negative result can occur if the quantity of IgG and IgM anti-CHIK present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor mat affect expected results.

6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

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