CE Certified HAV Viral Infection Blood Test Multi Specimen Reliable Reactive Result

Certified One Step HAV(hepatitis A virus) IgG/ IgM Rapid test ,Whole Blood/Serum/Plasma Specimen,, quick and easily

Product Name: One Step HAV(hepatitis A virus) IgG/ IgM Rapid Diagnostic Test Cassette

Intended Use:

The HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Hepatitis A virus (HAV) in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive result with the HAV IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Summary:

First isolated in 1973, Hepatitis A is an enveloped RNA virus in the picornaviridae family. Its transmission depends primarily on serial transmission from person to person by the fecal-oral route, but HAV can also be contracted from contaminated water, personal contact, sexual contact, and illicit drug use. Infection is characterized by rapid onset following an incubation period of approximately 28 days (15-50 days), which is followed by a rapid onset of symptoms. Signs and symptoms can include nausea, vomiting, diarrhea, dark urine, jaundice, fever, headache, weight loss, and abdominal pain. The likelihood of symptoms increases with age. Acute illness typically does not last more than two months. There is no chronic viral shedding and no chronic stage of the disease, although recurrences, acute fulminant hepatitis, and other complications may occur.

IgM anti-HAV antibodies are detectable at or prior to onset of clinical illness, and decline in about 3 to 6 months. IgG anti-HAV appears soon after IgM, persists for years after infection, and confers lifelong immunity. The presence of total anti-HAV and the absence of IgM anti-HAV can be used to differentiate between past and current infections. IgM assays can detect antibody for a short period of time in persons recently administered hepatitis A vaccine, but the lower concentrations found 4 to 6 months after the onset of infection typically do not produce a positive test result.

TEST PRINCIPLE

The HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of:

1) a burgundy colored conjugate pad containing HAV antigen conjugated with colloidal gold (HAV Ag conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (M line and G line) and a control line (C line). The M line is pre-coated with mouse anti-human IgM, the G line is precoated with mouse anti-human IgG and the C line is pre-coated with a control antibody. When an adequate volume of test specimen and sample diluent are dispensed into the sample well and buffer well respectively, the specimen migrates by capillary action across the cassette.

Anti-HAV IgM, if present in the specimen, will bind to the HAV Ag conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-human IgM, forming a burgundy colored M line, indicating a HAV IgM positive test result. Anti-HAV IgG, if present in the specimen, will bind to the HAV Ag conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-human IgG, forming a burgundy colored G line, indicating a HAV IgG positive test result. Absence of both test lines (M and G) suggests a negative result.

The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of control line antibodies, regardless of the color development on the test lines (M and G). Otherwise, the test result is invalid and the specimen must be retested with another device.

TEST PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Once thawed, mix the specimen well prior to performing the assay.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Label the device with the specimen ID number.

Step 4: Using a squeezing motion, fill the capillary pipette with the serum, plasma or whole blood. Do not exceed the specimen line (see following image). The volume of the specimen is approximately 5 µL. For maximum precision, transfer the specimen using a pipette capable of delivering 5 µL volumes.

Holding the capillary pipette vertically, dispense the entire specimen into the center of the sample well (S well), making sure that there are no air bubbles.

Immediately add 2 drops (approximately 60-80 µL) of sample diluent into the buffer well (B well) with the bottle positioned vertically

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The HAV IgG/IgM Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HAV IgM test; the results show that The HAV IgM Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

Relative Sensitivity: 99.9% (95%CI*: 94.2%-100%)

Relative Specificity: 99.5% (95%CI*: 98.3%-99.9%)

Accuracy: 95.6% (95%CI*: 98.5%-99.9%) *95% Confidence Intervals

The HAV IgG/IgM Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HAV IgG test; the results show that The HAV IgG Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

Relative Sensitivity: 99.9% (95%CI*: 94.2%-100%)

Relative Specificity: 99.5% (95%CI*: 98.3%-99.9%)

Accuracy: 95.6% (95%CI*: 98.5%-99.9%) *95% Confidence Intervals