HAV
HBsAb
HBsAg
HBcAb
HCV
HEV
- Intended Use
The One Step HAV IgM Test is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Hepatitis A Virus (HAV) in Serum/Plasma to aid in the diagnosis of Hepatitis A Virus.
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. Take samples out from a frozen condition, allow samples to reach room temperature and label them.
2. Remove the cassette from the foil pouch prior to use and place it on a flat surface. Add 10 μl of serum sample into the sample well, and immediately add 3 drops (90ul-100ul) of buffer.
3. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 15 minutes should be considered invalid.
- Interpretation of Results
1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result.
2. Negative: Only one color band appearing at the control line (C) indicates negative result.
3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.
- Product Properties
Product Format: Cassette
Products name: HAV IgM Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- Intended Use
This kit is intended for the qualitative measurement Hepatitis B surface antigen (HBsAb) in human serum, and is appropriate for a rapid, simple and accurate auxiliary diagnosis of HBV infection. As it is valuable for the auxiliary diagnosis, screening of blood donors, and rapid detection of HBV infection, the kit can be used in blood centers, clinical settings, epidemic prevention stations and research centers.
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. Open the foil pouch and take out the test cassette
2. Add 100ul or 2-3 drops of serum sample into the sample well which is at the bottom of the cassette.
3. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 15 minutes should be considered invalid.
- Interpretation of Results
1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result.
2. Negative: Only one color band appearing at the control line (C) indicates negative result.
3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.
- Product Properties
Product Format: Cassette
Products name: HBsAb Serum/Plasma Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, BV
- Intended Use
This kit is intended for the qualitative measurement Hepatitis B surface antigen (HBsAg) in human whole blood, serum or plasma, and is appropriate for a rapid, simple and accurate auxiliary diagnosis of HBV infection. As it is valuable for the auxiliary diagnosis, screening of blood donors, and rapid detection of HBV infection, the kit can be used in blood centers, clinical settings, epidemic prevention stations and research centers
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Whole Blood: Add 1 drop (45-55ul) of whole blood sample into the sample well, and immediately add 1 drop (30-40ul) of buffer.
3. Serum/Plasma: Add 1 drop (40-50ul) of serum/plasma sample into the sample well, and immediately add 1 drop (30-40ul) of buffer.
4. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 20 minutes should be considered invalid.
- Interpretation of Results
1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result.
2. Negative: Only one color band appearing at the control line (C) indicates negative result
3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.
- Product Properties
Product Format: Cassette
Products name: HBsAg Whole Blood/Serum/Plasma Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Whole Blood/Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- Intended Use
This kit is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B virus core antibody (HBcAb/anti-HBc) in Serum / Plasma
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. Open the foil pouch and take out the test cassette.
2. Add 100ul or 2-3 drops of serum/plasma sample into the sample well which is at the bottom of the cassette.
3. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 15 minutes should be considered invalid.
- Interpretation of Results
1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result
2. Negative: Only one color band appearing at the control line (C) indicates negative result.
3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.
- Product Properties
Product Format: Cassette
Products name: HBcAb Serum/Plasma Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, SGS
- Intended Use
This kit is intended for the qualitative measurement antibodies against Hepatitis C virus (HCV) in human whole blood, serum or plasma, and is appropriate for a rapid, simple and accurate auxiliary diagnosis of HCV infection. As it is valuable for the auxiliary diagnosis, screening of blood donors, and rapid detection of HCV infection, the kit can be used in blood centers, clinical settings, epidemic prevention stations and research centers
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Whole Blood: Add 1 drop (40-50ul) of whole blood sample into the sample well, and immediately add 1 drop (35-50ul) of buffer.
3. Serum/Plasma: Add 1 drop (30-45ul) of serum/plasma sample into the sample well, and immediately add 1 drop (35-50ul) of buffer.
4. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 20 minutes should be considered invalid.
- Interpretation of Results
1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result.
2. Negative: Only one color band appearing at the control line (C) indicates negative result.
3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.
- Product Properties
Product Format: Cassette
Products name: HCV Whole Blood/Serum/Plasma Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, BV
- Intended Use
The One Step HEV IgM Test is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to hepatitis E virus in Whole Blood /Serum / Plasma to aid in the diagnosis of HEV infection. The test is based on immunochromatography and can give a result within 15 minutes
- Storage and Stability
Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
- Assay Procedure
1. Take samples out from a frozen condition, allow samples to reach room temperature and label them.
2. Remove the cassette from the foil pouch prior to use and place it on a flat surface. Add 10 μl of serum sample into the sample well, and immediately add 3 drops (90ul-100ul) of buffer.
3. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 15 minutes should be considered invalid.
- Interpretation of Results
1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result.
2. Negative: Only one color band appearing at the control line (C) indicates negative result.
3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.
- Product Properties
Product Format: Cassette
Products name: HEV IgM Test Cassette
Methodology: Colloidal Gold
Specification: 4mm
Specimen: Serum/Plasma
Reading Time: with 10-15 minutes
Service: OEM and ODM, Technology and Policy support
Shelf life: 24 months
Certificates: ISO13485, BV
