Accu-Tell^® Calprotectin Semi-Quantitative Rapid Test Cassette (Feces)

CATALOG

KEY POINTS

Detection for: Calprotectin in feces

Reading time: 10 minutes

Relative Sensitivity: 100%

Relative Specificity: 97.7 %

Relative Accuracy: 98.0 %

INTRODUCTION

Calprotectin, first described in 1980[1], is aprotein found in the cytosol of neutrophils and macrophages composed of two subunits S100A8 and S100A9. It is released extracellularly in times of cell stress or damage and can be detected within feces and thus can be used as a sensitive marker of intestinal inflammation. It is stable in feces for up to seven days at room temperature and has a homogenous distribution in feces, properties which lend it to testing spot fecal samples.

INTENDED USE

ACCU-TELL^® Calprotectin Semi-Quantitative Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the semi-quantitative detection of Calprotectin in feces.

TEST PROCEDURE

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

1. To collect fecal specimens:

Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean, dry specimen collection container to obtain enough virus particles. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.

2. To process fecal specimens:

Unscrew the cap of the specimen collection tube， then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 10~50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.

3. 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.

4. Place the cassette on a clean and level surface. Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80uL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

5. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 15 minutes.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The performance of ACCU-TELL^® Calprotectin Semi-Quantitative Cassette (Feces) has been evaluated with 100 clinical specimens.

Relative sensitivity: 12/12=100% (CI*: 77.9%~100%)

Relative specificity: 86/88 =97.7% (CI*: 92.0%~99.7%)

Relative Accuracy: 98/100 =98.0 % (CI*: 93.0%~99.8%)

*95% Confidence Interval

Precision

Intra-Assay

Assays were carried out to determine assay reproducibility using replicates of 10 tests in three different runs for each of three lots using calprotectin specimen levels at 0 ug/g, 50ug/g and 200ug/g. The specimens were correctly identified >99.9% of the time.

Inter-Assay

Between-run precision has been determined by using the five calprotectin specimen levels at 0 ug/g, 50ug/g and 200ug/g of calprotectin in 3 independent assays. Three different lots of the calprotectin Semi-Quantitative Rapid Test Cassette (feces) have been tested using these specimens. The specimens were correctly identified >99.9%of the time.

Interfering Substances

The following substances do not interfere with the test results at the indicated concentrations: lactoferrin at 3mg/ml, Adenovirus, Rotavirus, E.coli, helicobacter pylori and Salmonella choleraesius.

LIMITATIONS

1. ACCU-TELL^® Calprotectin Semi-Quantitative Cassette (Feces) is for professional in vitro diagnostic use. The test should be used for the detection of calprotectin in human feces specimens only.

2. ACCU-TELL^® Calprotectin Semi-Quantitative Cassette (Feces) will only indicate the semi‐quantitative level of Calprotectin in the specimen and should not be used as the sole criteria for evaluating inflammatory conditions.

3. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician afterall clinical and laboratory findings have been evaluated.

4. Calprotectin values near the cut-off level Test line 1(T1: 50ug/g) and Test line 2 (T2: 200ug/g), should be reported with caution as with all quantitative assays there exists some level of variation. Therefore, a T line with slightly higher intensity than T2can also represent a value slightly below 200ug/g. Similar observations may occur with values near 50ug/g. A repeat test or further quantitative test is recommended.

5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended.

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