HCV rapid device (serum/plasma) box of 40

HCV Rapid Device

(Serum/Plasma)

Catalogue No. 8/006 – 40 tests

The HCV Rapid Device (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.

INTRODUCTION

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. Antibody to HCV is found in over 80% of patients with welldocumented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens (1, 2). Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests (3, 4). The HCV Rapid Device (Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a serum or plasma specimen. The test utilises a combination of protein A coated particles and recombinant HCV proteins to selectively detect antibody to HCV in serum or plasma. The recombinant HCV proteins used in the device are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.

PRINCIPLE OF THE TEST

The HCV Rapid Device (Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibody to HCV in serum or plasma. The membrane is coated with recombinant HCV antigen on the test line region of the device. During testing, the serum or plasma specimen reacts with the Protein A coated particles. The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen on the membrane and generate a coloured line. Presence of this coloured line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a coloured line will always appear at the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred.

KIT CONTENTS

• Devices - containing protein A coated particles and HCV antigen coated on the membrane.

• Buffer.

• Disposable specimen droppers.

• Package insert.

MATERIALS REQUIRED BUT NOT PROVIDED

• Specimen collection container.

• Centrifuge (for plasma only).

• Timer.

• Pipette and disposable tips (optional).

PRECAUTIONS

1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens and kits are handled.

3. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.

4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

5. Humidity and temperature can adversely affect results.

STORAGE AND STABILITY

1. Store as packaged in the sealed pouch at 2-30°C.

2. The device is stable until the expiry date printed on the sealed pouch.

3. The device must remain in the sealed pouch until use.

4. DO NOT FREEZE.

5. Do not use beyond the expiry date.

SPECIMEN PREPARATION

• The HCV Rapid Device (Serum/Plasma) can be performed using either serum or plasma.

• Separate the serum or plasma from blood as soon as possible to avoid haemolysis. Only clear, non-haemolysed specimens can be used.

• Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.

• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

• If specimens are to be shipped, they should be packed in compliance with usual regulations for transportation of aetiological agents.

PROCEDURE

1. Allow device, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

2. Bring the pouch to room temperature before opening it. Remove the device from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

3. Place the device on a clean and level surface. Transfer the specimen by a pipette or dropper as detailed below:

• Pipette: Transfer 5µl of serum or plasma to the specimen well (S) of the device. Add 2 full drops of buffer (approx. 80µl) and start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration 1 below.

• Disposable Specimen Dropper: Holding the dropper vertically, draw the specimen up to the fill line as shown in illustration 2 (approx. 5µl). Transfer the specimen to the specimen well (S) of the test device. Add 2 full drops of buffer (approx. 80µl) and start the timer. Avoid trapping air bubbles in the specimen well (S).

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

INTERPRETATION OF RESULTS

POSITIVE: *Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T). *NOTE: The intensity of the red colour in the test line region (T) may vary depending on the concentration of HCV antibodies present in the specimen. Therefore any shade of red in the test (T) region should be considered positive.

NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new device. If the problem persists, discontinue using the device immediately and contact your local distributor.

QUALITY CONTROL

A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit. However, it is recommended that positive and negative controls are sourced from a local competent authority and tested as a good laboratory practice, to confirm the test procedure and verify the test performance.

LIMITATIONS

1. The HCV Rapid Device (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. The HCV Rapid Device (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.

EXPECTED VALUES

The HCV Rapid Device (Serum/Plasma) has been compared with a leading commercial HCV EIA test. The correlation between these two systems is 98%.

PERFORMANCE CHARACTERISTICS

Sensitivity: The HCV Rapid Device (Serum/Plasma) has passed a seroconversion panel and compared with leading commercial HCV EIA test using clinical specimens.

Specificity: The recombinant antigens used for the HCV Rapid Device (Serum/Plasma) are encoded by genes for both structural (nucleocapsid) and non-structural proteins. The HCV Rapid Device (Serum/Plasma) is highly specific for antibodies to Hepatitis C Virus compared with a leading commercial HCV EIA test.

Intra-Assay precision: Within-run precision has been determined by using 15 replicates of three specimens: a negative, a low positive and a high positive. The negative, low positive and high positive values were correctly identified 98% of the time. Inter-Assay precision: Between-run precision has been determined by 15 independent assays on the same three specimens: a negative, a low positive and a high positive. Three different lots of the HCV Rapid Device (Serum/Plasma) have been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 98% of the time.