HAV

HAV IgM and IgG Test Cassette is a single use, rapid device intended for qualitative detection of IgM-class and IgG-class antibodies to hepatitis A virus (HAV) in whole blood, serum, plasma or feces samples. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV.

Features
  • Two band results for simple interpretation
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
  • Reagents included
Specifications
  • Sensitivity: IgM 98.5%
  • Specificity: IgM 97.7%
  • Specimen: Whole Blood, Serum, Plasma, Feces
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HAV IgM Rapid Test Serum/Plasma GCHAV(IgM)- 302Ba Cassette 25 Tests/Kit CE marked
HAV IgG/IgM Rapid Test Whole blood/Serum/Plasma GCHAV(IgG/IgM)-402a Cassette 25 Tests/Kit CE marked
HAV Antigen Rapid Test Feces GCHAV-602a Cassette 25 Tests/Kit CE marked

HBV

The Hepatitis B Virus Rapid Tests are rapid chromatographic immunoassays for the qualitative detection of Hepatitis B Surface Antigen (HBsAg), Hepatitis B Surface Antibody (HBsAb), Hepatitis B Envelope Antigen (HBeAg), Hepatitis B Envelope Antibody (HBeAb) and Hepatitis B Core Antibody (HBcAb) in serum, plasma or whole blood.

Features
  • Two band results for simple interpretation
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
  • Reagents included
Specifications:
  • Sensitivity: HBcAb 96.3%; HBeAb & HbeAg 94.5%; HBsAb 99%; HBsAg 99.4%
  • Specificity: HBcAb 96.8%; HBeAb & HbeAg 97.3%; HBsAb 99.56%; HBsAg 99.5%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Cut-Off Value Kit Size Qualification
HBcAb Hepatitis B Core Antibody Test Serum/Plasma GCHBcb-302a Cassette 2 NCU 25 Tests/Kit /
GCHBcb-302b Cassette 8 NCU 25 Tests/Kit /
Whole blood/Serum/Plasma GCHBcb-402a Cassette 2 NCU 25 Tests/Kit /
HBeAb Hepatitis B Envelope Antibody Test Serum/Plasma GCHBeb-302a Cassette 2 NCU 25 Tests/Kit /
GCHBeb-302b Cassette 8 NCU 25 Tests/Kit /
Whole blood/Serum/Plasma GCHBeb-402a Cassette 2 NCU 25 Tests/Kit /
HBeAg Hepatitis B Envelope Antigen Test Serum/Plasma GCHBeg-302a Cassette 0.5 NCU 25 Tests/Kit /
Whole blood/Serum/Plasma GCHBeg-402a Cassette 0.5 NCU 25 Tests/Kit /
HBsAb Hepatitis B Surface Antibody Test Serum/Plasma GCHBsb-301a Strip 30 mIU/mL 50 Tests/Kit /
GCHBsb-302a Cassette 30 mIU/mL 25 Tests/Kit /
Whole blood/Serum/Plasma GCHBsb-401a Strip 30 mIU/mL 50 Tests/Kit /
GCHBsb-402a Cassette 30 mIU/mL 25 Tests/Kit /
GCHBsb-402b Cassette 20 mIU/mL 25 Tests/Kit /
HBsAg Hepatitis B Surface Antigen Rapid Test Serum/Plasma GCHBsg-301a Strip 1 ng/mL 50 Tests/Kit /
GCHBsg-302a Cassette 1 ng/mL 25 Tests/Kit /
Whole blood/Serum/Plasma GCHBsg-401a Strip 1 ng/mL 50 Tests/Kit /
GCHBsg-402a Cassette 1 ng/mL 25 Tests/Kit /

HCV

The Hepatitis C (HCV) Antibody Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of anti-HCV antibodies IgG, IgM, and IgA in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of HCV infection.

Features
  • Two band results for simple interpretation
  • Detects anti-HCV IgG, IgM and IgA
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
Specifications
  • Sensitivity: 98.1%
  • Specificity: 98.9%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HCV Hepatitis C Virus Test Serum/Plasma GCHCV-301a Strip 50 Tests/Kit /
Serum/Plasma GCHCV-302a Cassette 25 Tests/Kit CE 0123
Whole blood/Serum/Plasma GCHCV-401a Strip 50 Tests/Kit /
Whole blood/Serum/Plasma GCHCV-402a Cassette 25 Tests/Kit CE 0123

HEV

The Hepatitis C (HCV) Antibody Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of anti-HCV antibodies IgG, IgM, and IgA in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of HCV infection.

Features
  • Easy operate and simple interpretation
  • Detects anti-HEV IgM
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
  • Reagents included
Specifications
  • Sensitivity: >99%
  • Specificity: 98.9%
  • Specimen: Serum, Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HEV Hepatitis E Virus Antibody Test Serum/Plasma GCHEV-302a√ Cassette 25 Tests/Kit CE marked

HIV

The Human Immunodeficiency Virus Rapid Tests are rapid chromatographic immunoassays for the qualitative detection of HIV p24 antigen and/or antibodies (IgG, IgM, and IgA) to HIV-1 and/or HIV-2 and/or Subtype O in serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HIV.

Features
  • Facilitates patient treatment decisions quickly
  • Simple, time-saving procedure
  • High sensitivity
  • Reliable results
  • CE List A certificate obtained
Specifications
  • Sensitivity: >99%
  • Specificity: >99%
  • Specimen: whole blood, serum or plasma
  • Time to Results: 10 – 15 minutes
  • Shelf Life: 24 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HIV 1/2 Ab Rapid Test Serum/Plasma GCHIV-301a Strip 50 Tests/Kit /
HIV 1/2 Ab Rapid Test Serum/Plasma GCHIV-302a√ Cassette 25 Tests/Kit CE 0123
HIV 1/2 Ab Rapid Test Whole Blood/Serum/Plasma GCHIV-401a Strip 50 Tests/Kit /
HIV 1/2 Ab Rapid Test Whole Blood/Serum/Plasma GCHIV-402a√ Cassette 25 Tests/Kit CE 0123
HIV 1/2 Ab Tri-line Rapid Test Whole Blood/Serum/Plasma GCHIV-GT402a Cassette 25 Tests/Kit /
HIV 1/2/O Ab Tri-line Rapid Test Serum/Plasma GCHIV-T302b Cassette 25 Tests/Kit /
HIV 1/2/O Ab Tri-line Rapid Test Whole Blood/Serum/Plasma GCHIV-T402a Cassette 25 Tests/Kit /
HIV Ab/Ag Rapid Test Whole Blood/Serum/Plasma GCHIV(Ag/Ab)-402a Cassette 25 Tests/Kit /

VISITECT CD4

The VISITECT CD4 Advanced Disease Rapid Test is a manually operated semi-quantitative assay for the estimation of CD4 protein on the surface of CD4+ T cells in human whole blood (capillary or EDTA venous) to indicate whether the level is above or below 200 cells/μL within prediagnosed HIV patients.

Features
  • Rapid estimation CD4+ T cell count levels
  • Receive an accurate result within an assay time for just 40 minutes.
  • Accelerate clinical diseases management
  • Test anywhere, any time
  • Reduce patient loss to follow-up
Specifications
  • Capillary samples: Sensitivity: 89.3%; Specificity: 92.3%;
  • Venous blood: Sensitivity: 86.3%; Specificity: 92.8%;
  • Specimen: whole blood
  • Assay time: 40 minutes
  • Storge: 2-30℃
  • Shelf Life: 12 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
VISITECT CD4 Advanced Disease Whole blood OD376 Cassette 50 Tests/Kit CE marked, WHO PQ

Syphilis (TP)

The Syphilis Ab Rapid Test Cassette uses a combination of syphilis antigen-colloidal gold conjugate and immobilized syphilis antigen to detect T. pallidum antibodies (IgG, IgM and IgA) qualitatively and selectively in whole blood, serum or plasma.

Features
  • Two band results for simple interpretation
  • Detects syphilis antibodies IgG ,IgM and IgA
  • Room temperature storage or refrigerated (2-30⁰C)
  • Easy to read results
  • Internal control included
Specifications:
  • Sensitivity: 99.54%
  • Specificity: 100%
  • Specimen: Whole blood/Serum/Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
Syphilis Antibody Rapid Test Serum/Plasma GCSYP-301a Strip 50 Tests/Kit CE marked
Syphilis Antibody Rapid Test Serum/Plasma GCSYP-302a Cassette 25 Tests/Kit CE marked
Syphilis Antibody Rapid Test Whole blood/Serum/Plasma GCSYP-401a Strip 50 Tests/Kit CE marked
Syphilis Antibody Rapid Test Whole blood/Serum/Plasma GCSYP-402a Cassette 25 Tests/Kit CE marked
HBsAg/HCV/HIV/Syphilis Combo Rapid Test Serum/Plasma GCHBCISY-345a Multi-panel Cassette 20 Tests/Kit /
HBsAg/HCV/HIV/Syphilis Combo Rapid Test Whole blood/Serum/Plasma GCHBCISY-445a Multi-panel Cassette 20 Tests/Kit /

HBV HBcAb/HBeAb/HBeAg/HBsAb/HBsAg Combo

The Hepatitis B Virus Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface Antigen (HBsAg), Hepatitis B surface Antibody (HBsAb), Hepatitis B Envelop Antigen (HBeAg), Hepatitis B Envelope (HBeAb), and Hepatitis B Core Antibody (HBcAb) in human whole blood, serum and plasma.

Features
  • Two band results for simple interpretation
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
  • Reagents included
Specifications
  • Clinical Evaluations:
    • HBsAg: Sensitivity: >99%; Specificity: 96.8%; Accuracy: 98.3%
    • HBsAb: Sensitivity: >99%; Specificity: 98.7%; Accuracy: 99.5%
    • HBeAg: Sensitivity: 98.2%; Specificity: 98.2%; Accuracy: 98.2%
    • HBeAb: Sensitivity: 94.5%; Specificity: 97.3%; Accuracy: 96.6%
    • HBcAb: Sensitivity: 96.3%; Specificity: 96.8%; Accuracy: 96.4%
  • Specimen: Whole blood/Serum/Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months after the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HBV HBcAb/HBeAb/HBeAg/HBsAb /HBsAg Combo Test Serum/Plasma GCHBV-355a Cassette 20 Tests/Kit /
Whole blood/Serum/Plasma GCHBV-455a Cassette 20 Tests/Kit /

HBsAg & HCV Combo

The HBsAg & HCV Combo Rapid Test is an immunochromatographic assay for the qualitative detection of HCV antibodies and HBsAg respectively, in human whole blood, serum or plasma samples. It is intended for professional use as an aid in diagnosing HCV, HBsAg infections.

Features
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
  • Reagents included
Specifications
  • Clinical Evaluations:
    • HCV: Sensitivity: 98.8%; Specificity: 99.6%; Accuracy: 99.5%
    • HBsAg: Sensitivity: 99.5%; Specificity: 99.7%; Accuracy: 99.7%
  • Specimen: Whole blood/Serum/Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months after the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HBsAg/HCV Combo Rapid Test WB/S/P GCHBC-402a Cassette 25 Tests/Kit /

HBsAg/HCV/HIV/Syphilis Combo

The HIV/HCV/HBsAg/Syphilis Combo Rapid Test is a rapid, immunochromatographic assay for the qualitative detection of HCV antibodies, HIV 1/2 virus- antibodies, HBsAg, and/or Treponema Pallidum antibodies respectively, in human whole blood, serum or plasma samples. It is intended for professional use as an aid in diagnosing HCV, HIV, HBV, and/or Syphilis infections. This assay provides only a preliminary result and all positive specimens should be confirmed with other qualified assays.

Features
  • Two band results for simple interpretation
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included
  • Reagents included
Specifications
  • Clinical Evaluations:
    • HCV: Sensitivity: 98.1%; Specificity: 98.9%; Accuracy: 98.9%
    • HBsAg: Sensitivity: 99.4%; Specificity: 99.5%; Accuracy: 99.5%
    • HIV: Sensitivity: 99.5%; Specificity: 99.8%; Accuracy: 99.8%
    • Syphilis: Sensitivity: 99.5%; Specificity: 99.7%; Accuracy: 99.7%
  • Specimen: Whole blood/Serum/Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months after the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HBsAg/HCV/HIV/Syphilis Combo Test Serum/Plasma GCHBCISY-345a Cassette 20 Tests/Kit /
Whole blood/Serum/Plasma GCHBCISY-445a Cassette 20 Tests/Kit /

HCV/HIV Combo

The HIV / HCV Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid, immunochromatographic assay for the qualitative detection of HCV antibodies, HIV 1/2 virus- antibodies respectively, in human whole blood, serum or plasma samples. It is intended for professional use as an aid in diagnosing HCV, HIV infections. This assay provides only a preliminary result and all positive specimens should be confirmed with other qualified assays.

Features
  • Two band results for simple interpretation
  • Room temperature storage or refrigerated (2-30⁰C)
  • Reagents included
Specifications
  • Clinical Evaluations:
    • HCV: Sensitivity: 98.1%; Specificity: 98.9%; Accuracy: 98.9%
    • HIV: Sensitivity: 99.5%; Specificity: 99.8%; Accuracy: 99.8%
  • Specimen: Whole blood/Serum/Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months after the date of manufacture
Ordering Information
Product Description Specimen Catalog No. Format Kit Size Qualification
HCV/HIV Combo Test Whole blood/Serum/Plasma GCHCI-402a Cassette 25 Tests/Kit /

Healstone Biotech

UNIT#650-655 West Kent Ave North,
Vancouver, British Columbia, V6P 6T7

1 (604) 800-2434
info.healstone@healgen.com

DISCLAIMER: The health-related information provided on this website is for general information only. It is not intended to serve as medical advice and is not substitute to rely upon in place of a qualified practitioner in your jurisdiction. Healstone Biotech Inc, and its affiliates Healgen Scientific LLC. make every effort to ensure the accuracy and reliability of the information that appears on its website, but cannot guarantee that it is error-free or complete. Please note that actual products may differ slightly from specifications or the pictures. Not everything listed on this website has yet been licensed by Health Canada for sale. Please contact us for more detailed information.

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