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HEV IgG IgM Rapid Test

HEV IgG IgM Rapid Test

PocTell® HEV IgG IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–HEV virus and IgM anti- Hepatitis E virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with Hepatitis E virus. Any reactive specimen with the HEV IgG/IgM Rapid Test must be confirmed with alternative testing method(s)..

Product Introduction

INTENDED USE

 

PocTell® HEV IgG IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–HEV virus and IgM anti- Hepatitis E virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with Hepatitis E virus. Any reactive specimen with the HEV IgG/IgM Rapid Test must be confirmed with alternative testing method(s)..

HEV IgG IgM Rapid Test

Ordering Information

 

Test Item

Format

Specimen

Reaction Time

Shelf life

Kit Size

HEV

Cassette

S / P / WB

15 mins

24 months

25 T/Kit

 

TEST PRINCIPLE

 

According to the gold immunochromatographic test principle, the nitrocellulose membrane is coated with recombinant HEV-Ag and goat anti-mouse IgG antibody. Colloidal gold marked mouse anti-human IgM as a mark tracer. When detecting a positive sample, the HEV-IgM antibody in the sample can combine with the colloidal gold-mouse anti-human IgM monoclonal antibody on the gold label pad to form a complex, and move along the membrane under the chromatography. When passing through the detection line, it binds to the coated recombinant HEV-Ag to form a sandwich complex and aggregates and develops color. The free gold-labeled monoclonal antibody binds to the coated goat anti-mouse IgG antibody at the quality control line to develop color, the negative sample is only colored at the quality control line. .

 

36020250617135728

 

DIRECTIONS FOR USE

 

Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed. Place the test device on a clean, flat surface.

1.Remove the test device from the foil 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 device on a clean and level surface.

3.Drop 5μl Whole Blood/Serum/Plasma vertically onto the sample well. If a disposable plastic sample ring is used, the ring body should be completely immersed in the sample, and then the ring body vertical touch reagent plus sample should be sucked into the sample, and the membrane surface of the sample well of the sample should have wetting marks.

4.Add about 2-3 drops of (80μl-120μl) sample buffer onto the sample well of cassette. Observe the test results immediately within 15-20 minutes, the result is invalid over 20 minutes.

Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by a pipette capable to deliver 5µL of volume.

Set up a timer. Read the result at 15 minutes. Don't read result after 20 minutes. To avoid confusion, discard the test device after interpreting the result..

 

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