產品篩選條件: Viral Hepatitis

HEPAVASE MA-96 (TMB) (Anti-HAV IgM)

PRODUCT DESCRIPTION

This product is designed as an IgM capture ELISA for detection of acute Hepatitis A virus (HAV) infection. The solid phase is coated with capture antibodies specific for HAV IgM, while the liquid phase includes purified peroxidase-conjugated antibodies. It is optimized to detect early infection through IgM antibodies.

SPECIFICATION

Number of wells96
PrincipleIgM Capture
Assay formatQualitative
Total incubation time150 minutes
Sample typeSerum / Plasma
Sample volume10 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA

PERFORMANCE

1570 hospitalized patients were tested. The results are as follows：

The diagnostic sensitivity is 98%；The diagnostic specificity is 100%

Inter-assay precision CV< 20%Intra-assay precision CV< 15%

ORDERING INFORMATION

Catalogue No.Product
4AME3HEPAVASE MA-96 (TMB)

HEPAVASE A-96 (TMB) (Anti-HAV Antibody)

PRODUCT DESCRIPTION

This product is a competitive ELISA reagent designed for qualitative detection of Anti-HAV antibodies in human serum or plasma. With a 10 µL sample volume, 450 nm read wavelength, and 150-minute incubation time, it ensures sensitive and specific results (99.8% sensitivity, 99.5% specificity) with Inter-assay CV <25% and Intra-assay CV <20%. Certified by TFDA, it is reliable, user-friendly, and suited for clinical laboratory use.

SPECIFICATION

Number of wells96
PrincipleCompetitive
Assay formatQualitative
Total incubation time150 minutes
Sample typeSerum / Plasma
Sample volume10 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA

PERFORMANCE

1541 hospitalized patients were tested. The results are as follows：

The diagnostic sensitivity is 99.8%；The diagnostic specificity is 99.5%

Inter-assay precision CV< 25%Intra-assay precision CV< 20%

ORDERING INFORMATION

Catalogue No.Product
4AGE3GB HEPAVASE A-96 (TMB)

ANTICORASE MB-96 (TMB) (Anti-HBc IgM)

PRODUCT DESCRIPTION

This product is an IgM capture ELISA assay for qualitative detection of Anti-HBc IgM in human serum or plasma, indicative of acute hepatitis B virus (HBV) infection. It requires only 5 µL sample volume, with a 150-minute incubation and 450 nm read wavelength. Tested in 1,541 hospitalized patients, showing 96.1% sensitivity and 100% specificity. Certified by TFDA and CE; storage at 2-8°C.

SPECIFICATION

✱Notified body: 0344

Number of wells96
PrincipleIgM Capture
Assay formatQualitative
Total incubation time150 minutes
Sample typeSerum / Plasma
Sample volume5 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA / CE marked ✱

PERFORMANCE

1541 hospitalized patients were tested. The results are as follows：

The diagnostic sensitivity is 96.1%；The diagnostic specificity is 100%

Inter-assay precision CV< 25%Intra-assay precision CV< 20%

ORDERING INFORMATION

Catalogue No.Product
4CME3ANTICORASE MB-96 (TMB)

ANTICORASE B-96 (TMB) (Anti-HBc total)

PRODUCT DESCRIPTION

The GBC ANTICORASE B-96 (TMB) is a qualitative ELISA assay designed for the detection of total antibody against hepatitis B core antigen (Anti-HBc total) in human serum or plasma.

The assay employs the direct sandwich ELISA principle with antibodies immobilized in 96-well microplates and enzyme-conjugated components as the detection system. With a minimal sample volume of 50 µL and an incubation time of 90 minutes, the test provides rapid and reliable results.

Clinical validation in 5,812 hospitalized patients demonstrated 100% sensitivity and 99.8% specificity, with inter-assay CV < 15% and intra-assay CV < 20%. Results interpreted as Non-Reactive indicate no detectable Anti-HBc; Reactive samples confirm the presence of HBV core antigen antibodies and should be assessed in conjunction with clinical findings and other diagnostic markers.

Certified by TFDA and CE, the reagent is stable at 2–8°C and is well suited for both clinical diagnostics and epidemiological surveillance.

SPECIFICATION

✱Notified body: 0344

Number of wells96
PrincipleDirect Sandwich
Assay formatQualitative
Total incubation time90 minutes
Sample typeSerum / Plasma
Sample volume50 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA / CE marked ✱

PERFORMANCE

5,812 hospitalized patients were tested. The diagnostic sensitivity is 100%；The diagnostic specificity is 99.8%

Inter-assay precision CV< 15%Intra-assay precision CV< 20%

ORDERING INFORMATION

Catalogue No.Product
4CBE3ANTICORASE B-96 (TMB)

ANTISURASE B-96 (TMB) (Anti-HBs)

PRODUCT DESCRIPTION

This in vitro diagnostic qualitative ELISA assay detects antibodies against the Hepatitis B surface antigen (Anti-HBs) in human serum or plasma. Operated using a sandwich ELISA format with 96 wells, it requires 50 µL of specimen, with a total incubation time of 90 minutes and reading wavelength at 450 nm. Clinical testing among 235 hospitalized patients showed 100% sensitivity and 99.83% specificity. Certified by TFDA and CE. Non-Reactive results indicate absence of detectable Anti-HBs; Reactive results indicate presence of Anti-HBs antibody, to be interpreted alongside clinical findings.

SPECIFICATION

✱Notified body: 0344

Number of wells96
PrincipleSandwich
Assay formatQualitative
Total incubation time90 minutes
Sample typeSerum / Plasma
Sample volume50 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA / CE marked ✱

PERFORMANCE

235 hospitalized patients were tested. The diagnostic sensitivity is 100%；The diagnostic specificity is 99.83%

Inter-assay precision CV< 10%Intra-assay precision CV< 10%

ORDERING INFORMATION

Catalogue No.Product
4SBE3ANTISURASE B-96 (TMB)

ANTISURASE B-96 II (TMB) (Anti-HBs)

PRODUCT DESCRIPTION

This in vitro diagnostic quantitative ELISA reagent is designed for measuring antibodies against Hepatitis B surface antigen (Anti-HBs) in human serum or plasma. It operates via the sandwich ELISA principle, using 50 µL of sample with an incubation time of 90 minutes and readout at 450 nm. Clinical evaluation in 838 hospitalized patients revealed 100% sensitivity and 99.52% specificity, with both intra-assay and inter-assay precision CV < 15%. Certified under TFDA and CE 0344. Ideal for monitoring immune status following vaccination and supporting diagnostic decisions.

PERFORMANCE

838 hospitalized patients were tested. The diagnostic sensitivity is 100%；The diagnostic specificity is 99.52%

The precision results of ANTISURASE B-96 II (TMB) indicated a high level of precision with CV (%) < 25% within runs, between runs, days, sites, operators, and lots.

SPECIFICATION

✱Notified body: 0344

Number of wells96
PrincipleSandwich
Assay formatQuantitative
Total incubation time90 minutes
Sample typeSerum / Plasma
Sample volume50 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA / CE marked ✱

ORDERING INFORMATION

Catalogue No.Product
4SBE6ANTISURASE B-96 TMB II (Anti-HBs Quantitative) – 96T

NANBASE C-96 V4.0 (Anti-HCV)

PRODUCT DESCRIPTION

This product is a direct sandwich ELISA reagent for qualitative detection of Anti-HCV antibodies in human serum or plasma, intended for identifying current or past infection. It uses a 100 µL sample volume with a 105-minute incubation and read wavelength at 450 nm. Clinical validation shows 100% sensitivity and 99.8% specificity. Certified under TFDA and CE 0344. Non-Reactive results indicate absence of detectable Anti-HCV antibody; Reactive results confirm presence and should be interpreted in conjunction with clinical findings and additional diagnostics.

SPECIFICATION

✱Notified body: 0344

Number of wells96 / 480
PrincipleDirect Sandwich
Assay formatQualitative
Total incubation time105 minutes
Sample typeSerum / Plasma
Sample volume100 μL
Reading wavelength450 nm
Storage2-8°C
CertificationTFDA / CE marked ✱

PERFORMANCE

The diagnostic sensitivity is 100%；The diagnostic specificity is 99.8%

PrecisionVariability%CV
Repeatabilitywithin run<10%
Reproducibilitybetween-day<20%
between-run<20%
between-sites<15%
between-operators<15%
between-lots<15%

ORDERING INFORMATION

Catalogue No.Product
4NAE3NANBASE C-96 V4.0 (Anti-HCV) – 96T
4NAE12NANBASE C-96 V4.0 (Anti-HCV) – 480T

GB HDV Ab

PRODUCT DESCRIPTION

This product is an in-vitro diagnostic qualitative ELISA kit for detection of antibodies to Hepatitis D Virus (HDV), including both IgG and IgM, in human serum or EDTA-plasma. It uses a direct sandwich ELISA format. Requires a 100 µL specimen, with total incubation time of 105 minutes, and reading at 450 nm. Clinical testing on 1,003 HDV Ab-positive specimens confirmed diagnostic sensitivity of 100% and specificity of 98.6%. Precision (CV) across runs, days, operators, sites, and lots is < 25%. Storage at 2-8°C. Non-Reactive indicates no detectable antibodies; Reactive indicates presence of HDV antibodies, to be interpreted with clinical correlation.

SPECIFICATION

Number of wells96
PrincipleDirect Sandwich
Assay formatQualitative
Total incubation time105 minutes
Sample typeSerum / Plasma
Sample volume100 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA

PERFORMANCE

1,003 HDV Ag seropositive specimens were tested. The diagnostic sensitivity is 100%；The diagnostic specificity is 98.6%

The precision results of ANTISURASE B-96 II (TMB) indicated a high level of precision with CV (%) < 25% within runs, between runs, days, sites, operators, and lots.

ORDERING INFORMATION

Catalogue No.Product
4EHD001GB HDV Ab – 96T

EASE BN-96 (TMB) (HBeAg/Anti-HBe)

PRODUCT DESCRIPTION

This is an in vitro diagnostic qualitative ELISA kit for detecting both Hepatitis B e antigen (HBeAg) and its corresponding antibody (Anti-HBe) in human serum or plasma. It uses the sandwich ELISA format, requiring 100 µL of sample and a total incubation time of 150 minutes, with reading at 450 nm. Clinical validation demonstrates HBeAg sensitivity 98.5%, specificity 99.11%; Anti-HBe sensitivity 99.0%, specificity 99.49%. Intra- and inter-assay precision CVs are < 10%. Non-Reactive results indicate no detection of the antigen/antibody; Reactive indicates detection and should be interpreted with clinical context. TFDA & CE certified.

SPECIFICATION

✱Notified body: 0344

Number of wells96
PrincipleSandwich
Assay formatQualitative
Total incubation time150 minutes
Sample typeSerum / Plasma
Sample volume100 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA / CE marked ✱

PERFORMANCE

The diagnostic sensitivity for GB EASE BN-96 HBeAg is 98.5%；The diagnostic specificity for GB EASE BN-96 HBeAg is 99.11%The diagnostic sensitivity for GB EASE BN-96 Anti-HBe is 99.0%；The diagnostic specificity for GB EASE BN-96 Anti-HBe is 99.49%

Inter-assay precision CV< 10%Intra-assay precision CV< 10%

ORDERING INFORMATION

Catalogue No.Product
4BNE3EASE BN-96 (TMB)

SURASE B-96 (TMB) (HBsAg)

PRODUCT DESCRIPTION

This product utilizes highly specific and high-affinity murine monoclonal antibodies immobilized on a 96-well microplate as the solid phase, and affinity-purified rat antibodies conjugated with peroxidase as the liquid phase. By employing heterologous antibodies in both phases, the assay significantly reduces cross-reactivity and minimizes false positives, ensuring superior performance and reliability.

The reagent is intended for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma, based on the ELISA sandwich principle. Samples yielding Non-Reactive results can be considered free of detectable HBsAg. Samples yielding Reactive results should be retested and confirmed with a neutralization assay; only confirmed reactive samples can be interpreted as containing HBsAg or Hepatitis B virus (HBV).

SPECIFICATION

✱Notified body: 0344

Number of wells96/480
PrincipleSandwich
Assay formatQualitative
Total incubation time110 minutes
Sample typeSerum / Plasma
Sample volume50 μL
Reading wavelength450 nm
Storage2-8°C
CertificationTFDA / CE marked ✱

PERFORMANCE

The diagnostic sensitivity is 100%；The diagnostic specificity is 99.58%

PrecisionVariability%CV
Repeatabilitywithin run<20%
Reproducibilitybetween-day<20%
between-run<15%
between-sites/between-operators<20%
between-lots<15%

ORDERING INFORMATION

Catalogue No.Product
4SGE3SURASE B-96 (TMB) – 96T
4SGE11SURASE B-96 (TMB) – 480T