產品篩選條件: Blood Banking

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

HIVASE 1+2 (Anti-HIV 1+2)

PRODUCT DESCRIPTION

This in vitro diagnostic ELISA assay is designed for qualitative detection of antibodies to HIV-1 and/or HIV-2 in human serum or plasma. The test uses a direct sandwich ELISA format with a 96-well microplate, a specimen volume of 50 µL, and an incubation time of 90 minutes, read at 450 nm. Certified by TFDA (Taiwan), it provides reliable HIV antibody screening. A Non-Reactive result indicates no detectable HIV-1/2 antibodies; Reactive indicates presence of antibodies and should be interpreted with clinical correlation.

SPECIFICATION

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

ORDERING INFORMATION

Catalogue No.Product
4HIV3GB HIVASE 1+2 (HIV 1+2)-96 – 96T
4HIV11GB HIVASE 1+2 (HIV 1+2)-480 – 480T

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

GB HIV Ag-Ab COMB

Product Information Download

Download GBC HIV Ag-Ab COMB (English Version)Download

PRODUCT DESCRIPTION

This product is based on the ELISA sandwich principle, utilizing highly specific antigen–antibody combinations to simultaneously detect HIV-1/2 antibodies and the HIV-1 p24 antigen. In the 96-well microplate, antibodies and antigens are immobilized as the solid phase, while purified peroxidase-conjugated components serve as the detection phase. This design minimizes cross-reactivity and reduces false positives, ensuring high sensitivity and reliability.

GB HIV Ag-Ab COMB assay is a manual 4th generation solid phase Enzyme-Linked Immunosorbent assay using a mixture of antigens and antibodies for the qualitative in vitro diagnostic screening in human serum or plasma (EDTA, Heparin, and Citrate) of antibodies to HIV-1 (group M and O), HIV-2 and HIV-1 p24 antigen. The device is for professional use only.

GB HIV Ag-Ab COMB assay is intended to be used as a screening test for donated blood to prevent transmission of HIV-1/HIV-2 to recipients of blood and blood components.

GB HIV Ag-Ab COMB assay is not intended to screen and diagnose acute or primary HIV infection.

GB HIV Ag-Ab COMB assay result does not distinguish between the detection of HIV-1 antibody, HIV-2 antibody, or HIV-1 p24 antigen and is not for diagnostic use.

PERFORMANCE

The diagnostic sensitivity is 100%；The diagnostic specificity is 99.9%.

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

SPECIFICATION

✱Notified body: 0344

Number of wells96/480
PrincipleSandwich
Assay formatQualitative
Total incubation time150 minutes
Sample typeSerum / Plasma
Sample volume100 μL
Reading wavelength450 nm
Storage2-8°C
CertificationTFDA / CE marked ✱

ORDERING INFORMATION

Catalogue No.Product
4EAIC11GB HIV Ag-Ab COMB – 96T
4EAIC13GB HIV Ag-Ab COMB – 480T