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Accu-Tell® PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

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Accu-Tell® PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the semi-quantitative detection of Procalcitonin in whole blood, serum or plasma.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
PCT Semi-Quantitative CassetteWhole Blood/Serum/PlasmaABT-INF-B26640T/20TCE


KEY POINTS

Detection for: Procalcitonin in whole blood, serum or plasma

Reading time: 5 minutes

Relative Sensitivity: 96.6%

Relative Specificity: 99.0 %

Relative Accuracy: 98.1 %

 

INTRODUCTION

The Procalcitonin (PCT) is a peptide hormone mainly produced by C cells of the thyroid and certain endocrine cells of the lung. Under normal expression conditions, procalcitonin is immediately cleaved into three specific fragments, an N terminal residue, calcitonin and katacalcin, levels of unprocessed procalcitonin rise significantly after bacterial infection, trauma of shock

 

INTENDED USE

ACCU-TELL® PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the semi-quantitative detection of Procalcitonin in whole blood, serum or plasma.

 

TEST PROCEDURE

PCT Rapid Test 1.JPG

Allow test cassette, specimen, and/or controls to equilibrate to 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 2 drops of serum or plasma (approximately 80µl) to the specimen well of the test cassette, then add 1 drops of buffer (approximately 40µl) and start the timer. Avoid trapping air bubbles in the specimen well. See the illustration above.

For venipuncture Whole Blood specimen:

3. Hold the dropper vertically and transfer 3 drops of whole blood (approximately 120µl) to the specimen well of the test cassette, then add 2 drops of buffer (approximately 80µl) and start the timer. See the illustration above.

For Fingerstick Whole Blood specimen:

3. Fill the capillary tube and transfer 120µl of Fingerstick whole blood to the specimen well of the test cassette, then add 2 drops of buffer (approximately 80µl) and start the timer. See the illustration above.

4. Wait for the colored line(s) to appear. The test result should be read at 5 minutes. Do not interpret the result after 8 minutes.

 

PERFORMANCE CHARACTERISTICS

Sensitivity and specificity

ACCU-TELL® PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested in comparison with a leading commercial PCT FEIA test using clinical specimens.

MethodFEIATotal
NegativePositive
ACCU-TELL®   PCT Semi-Quantitative Cassette (Whole Blood/Serum/Plasma)Result0-0.5ng/ml0.5-2.0ng/ml2.0-10ng/ml≥10ng/ml
0-0.5ng/ml99100100
0.5-2.0ng/ml1261028
2.0-10ng/ml0023023
≥10ng/ml00088
Total10027248159
%   Relative Accuracy99.0%96.3%95.8%100%98.1%
96.6%

Relative sensitivity: (26+23+8)/(27+24+8)=96.6%

(CI*: 88.3%~99.6%)

Relative specificity: 99/ (99+1) =99.0 % (CI*: 94.6%~99.9%)

Relative Accuracy: (26+23+8+99)/ (27+24+8+100) =98.1 %

(CI*: 94.6%~99.6%)

*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 PCT specimen levels at 0ng/ml, 0.5ng/ml, 2.0ng/ml, 10.0ng/ml and 100ng/ml. The specimens were correctly identified >99.9% of the time.

Inter-Assay

Between-run precision has been determined by using the five PCT specimen levels at 0ng/ml, 0.5ng/ml, 2.0ng/ml, 10.0ng/ml and 100ng/ml of PCT in 3 independent assays. Three different lots of ACCU-TELL® PCT Semi-Quantitative Cassette (Whole Blood/Serum/Plasma) 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: Human Albumin at 20mg/ml, Bilirubin at 6mg/ml, Hemachrome at 10mg/ml, Cholesterol at 5mg/ml and Triglyceride at 15mg/ml.

 

LIMITATIONS

1. ACCU-TELL® PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma) is for professional in vitro diagnostic use, and should only be used for the semi‐quantitative detection of Patent Cooperation Treaty.

2. ACCU-TELL® PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)  will only indicate the semi‐quantitative level of PCT 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 after all clinical and laboratory findings have been evaluated.

4. PCT values near the cut‐off level Test line 1 (T1: 0.5ng/ml), Test line 2 (T2: 2.0ng/ml), and Test line 3 (T3: 10.0ng/ml) 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 T3 can also represent a value slightly below 10.0ng/ml. Similar observations may occur with values near 2.0ng/ml and 0.5ng/ml. A repeat test or further quantitative test is recommended.

 

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