INTENDED USE

The HEV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis E type virus (HEV) in human serum/ plasma.

PRINCIPLE

HEV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HEV in human serum/plasma. Mouse anti human-IgM µ strands are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HEV recombinant antigens. If antibodies to HEV are present, a pink colored band will develop on the membrane in proportion to the amount of HEV antibodies present in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of antibodies to HEV.

REAGENTS AND MATERIALS PROVIDED

1. One sealed pouched cassette with desiccant & disposable pipettet.

1. Blood diluent in a dropper bottle. Store at 4-30°C.
2. One piece of operating instruction with 40 test pouches.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic uses only.
2. All patient samples should be treated as if capable of transmitting diseases.
3. Do not interchange reagents from different lots. Do not use test kit beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

STORAGE AND STABILITY

Store HEV Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.

SAMPLE COLLECTION AND PREPARATION

Plasma

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.

1. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

ASSAY PROCEDURE

1. Carefully apply 3µl sample into a centrifuge tube with 1.5ml dilution, oscillate and mix them to diluted sample.

2. Remove the test cassette from pouch by tearing.

3. Add 50-80 ul or 2-3 drops of mixture into sample well.

4. Observe the result in 20 minutes.

INTERPRETATION OF RESULTS

1. Negative: No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HEV antibody has been detected.
2. Positive: In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains HEV antibodies.
3. Invalid: If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

PERFORMANCE CHARACTERISTICS

668 HEV diagnostic samples were tested with the HEV Rapid Screen Test. The results are summarized in the table below.

Sensitivity=98.5%; Specificity=99.2%; Total accuracy=99.1%

Precision

Intra-assay

In the study, 38 replicate assays were performed with one positive and one negative specimen. Correct negative and positive results were registered in 100% of the assays.

Inter-assay

The study involved the same specimens containing one positive and one negative. The samples were analyzed in 38 independent assays with HEV Rapid Screen Test. Originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.

LIMITATION OF THE PROCEDURE

1. The test is to be used for the qualitative detection of antibodies to HEV.
2. A negative result does not rule out infection by HEV because the antibodies to HEV may be absent or may not be present in sufficient quantity to be detected at early stage of infection.