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

Product Description

CATALOG

KEY POINTS

Detection for: antibody to Hepatitis C Virus in serum or plasma;

Specimen volume: 25 μL;

Reading time: 10 minutes;

Relative sensitivity: 99.8% (95%CI*: 98.7%~100%);  

Relative specificity: 99.8% (95%CI*: 99.4%~100%);

Accuracy: 99.8% (95%CI*:99.5%~99.9%).

*Confidence Intervals

INTRODUCTION

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis.

INTENDED USE

ACCU-TELL^® HCV Rapid Test Cassette/Strip (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to Hepatitis C Virus in serum or plasma.

 For professional in vitro diagnostic use only.

TEST PROCEDURE

For Cassette:

For Strip:

For Cassette:

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 test cassette on a clean and level surface. Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 μL) to the specimen well of the test cassette, then add 2 drops of buffer (approximately 80 μL) and start the timer. Avoid trapping air bubbles in the specimen well. See the illustration below.

3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.

For Strip:

Allow test Strip, 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 Strip 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 Strip on a clean and level surface. Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 μL) to the specimen area, then add 2 drops of buffer (approximately 120 μL),and start the timer, see illustration below.

3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

The recombinant antigen used for ACCU-TELL^® HCV Rapid Test (Serum/Plasma) is encoded by genes for both structural (nucleocapsid) and non-structural proteins. ACCU-TELL^® HCV Rapid Test (Serum/Plasma) has passed a seroconversion panel and compared with a leading commercial HCV ELISA test using clinical specimens.

The results show that the relative sensitivity of ACCU-TELL^® HCV Rapid Test (Serum/Plasma) is 99.8%, and the relative specificity is 99.8%.

Relative sensitivity=426/427= 99.8% (95%CI*: 98.7%~100%);  

Relative specificity=1544/1547= 99.8% (95%CI*: 99.4%~100%);

Accuracy=(426+1544)/(426+1+1544+3)=99.8% (95%CI*:99.5%~99.9%).

*Confidence Intervals

The results show that the diagnostic sensitivity of ACCU-TELL^® HCV Rapid Test Cassette (Serum/Plasma) is 99.8%, and the diagnostic specificity is 99.8%.

Diagnostic sensitivity=426/427= 99.8% (95%CI*: 98.7%~100%);  

Diagnostic specificity=1544/1547= 99.8% (95%CI*: 99.4%~100%);

Accuracy=(426+1544)/(426+1+1544+3)=99.8% (95%CI*:99.5%~99.9%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 20 replicates of three specimens: a negative, a HCV low titer positive and a HCV high titer positive. The negative, HCV low titer positive and HCV high titer positive values were correctly identified 100% of the time.

Inter-Assay

Between-run precision has been determined by 20 independent assays on the same three specimens: a negative, a HCV low titer positive and a HCV high titer positive.  Three different lots of ACCU-TELL^® HCV Rapid Test Cassette (Serum/Plasma) have been tested over a 3-month period using negative, HCV low titer positive and HCV high titer positive specimens. The specimens were correctly identified 100% of the time.

Cross-reactivity

There was no cross reactivity for ACCU-TELL^® HCV Rapid Test (Serum/Plasma) to be tested by HAMA, HBsAg, HBsAb, HbeAg, HBeAb, HBcAb, anti-HIV, anti-Syphilis, anti-H. Pylori, MONO, anti-CMV, anti-Rubella and anti-Toxoplasmosis positive specimens. Some cross-reactivity was observed with samples positive for Rheumatoid Factor, and EBV IgM

Interfering Substances

The following potentially interfering substances were added to HCV negative and positive specimens.

Acetaminophen:  20 mg/dL                    Caffeine: 20 mg/dL

Acetylsalicylic Acid:  20 mg/dL               Gentisic Acid: 20 mg/dL

Ascorbic Acid:  2g/dL                             Albumin: 2 g/dL

Creatine: 200 mg/dL                              Hemoglobin 1000mg/dL

Bilirubin: 1g/dL                                       Oxalic Acid: 60mg/dL

None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

1. ACCU-TELL^® HCV Rapid Test (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of antibodies to HCV in serum or plasma specimen.

2. ACCU-TELL^® HCV Rapid Test (Serum/Plasma) will only indicate the presence of antibodies to HCV in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis C viral infection.

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

4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is recommended. A negative result at any time does not preclude the possibility of Hepatitis C Virus infection.

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