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Infectious Disease - Tropical & Vector-Borne

Chagas

The Chagas Antibody Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human 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 T. Cruzi.

Key Benefits:

  • Two band results for simple interpretation
  • Detects Chagas IgG Antibody
  • Room temperature storage or refrigerated (2-30⁰C)
  • Reagents included
  • Internal control included

Specifications:

  • Sensitivity: 94.7%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Chagas Antibody Test
S/P
GCCHA-302a
Cassette/
25 Tests/Kit
CE-IVDD
Chagas Antibody Test
WB/S/P
GCCHA-402a
Cassette/
25 Tests/Kit
CE-IVDD
S: Serum, P: Plasma, WB: Whole Blood

Dengue

The Dengue Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of anti-dengue IgG, IgM antibodies and/or NS1 protein in human whole blood, serum, or plasma. This test serves as an aid in the diagnosis of primary and secondary Dengue infections.

Key Benefits:

  • Detection of Dengue IgM & IgG antibody and/or NS1 antigen
  • Analysis of primary or secondary infection
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included

Specifications:

  • Sensitivity: IgG/IgM 95.8%; NS1 95.7%
  • Specificity: IgG/IgM 99.0%; NS1 98.3%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Dengue IgG/IgM Antibody Test
WB/S/P
GCDEN(ab)-402c
Cassette/
25 Tests/Kit
CE-IVDD
Dengue NS 1 Antigen Test
WB/S/P
GCDEN(NS)-402c
Cassette/
25 Tests/Kit
CE-IVDD
Dengue NS 1 & lgG/lgM Combo Test
WB/S/P
GCDEN-425a
Cassette/
20 Tests/Kit
CE-IVDD
The Dengue Rapid Test Device is not available for sale in the US. For EU and other countries, please contact us for more information. S: Serum, P: Plasma, WB: Whole Blood

V. cholera

The V. cholerae O1/O139 Antigen Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of Vibrio cholerae O1 and/or O139 in human fecal specimens.

Key Benefits:

  • Detection of Vibrio cholerae O1 and O139 antigen
  • Analysis of primary or secondary infection
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included

Specifications:

  • Sensitivity: 1.0 x 105 CFU/mL (for O1 and O139)
  • Specimen: Feces
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
V. cholerae O1 Antigen Test
Feces
GCVCH(O1)-602a√
Cassette/
20 Tests/Kit
CE-IVDD
V. cholerae O1/O139 Antigen Rapid Test
Feces
GCVCH(O1/O9)-602a√
Cassette/
20 Tests/Kit
CE-IVDD
The V. cholerae O1/O139 Antigen Rapid Test is not available for sale in the US. For EU and other countries, please contact us for more information.

Chikungunya

The Chikungunya IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative test which utilizes recombinant antigens derived from its structure protein and detects IgM anti-CHIK in human whole blood, serum or plasma within 15 minutes.

Key Benefits:

  • Two band results for simple interpretation
  • Detects IgM anti-CHIK
  • Room temperature storage or refrigerated (2-30⁰C)
  • Easy to read results

Specifications:

  • Sensitivity: 96.9%
  • Specificity: 98.6%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Chikungunya IgM Rapid Test
Serum/Plasma
GCCHK(IgM)-302a
Cassette/
25 Tests/Kit
CE marked
Chikungunya IgM Rapid Test
Whole blood/Serum/Plasma
GCCHK(IgM)-402a
Cassette/
25 Tests/Kit
CE marked
Chikungunya lgG/IgM Rapid Test
Whole blood/Serum/Plasma
GCCHK(lgG/IgM)-402a
Cassette
/
25 Tests/Kit
CE marked
The Chikungunya IgM Rapid Test is not available for sale in the US. For EU and other countries, please contact us for more information.

Giardia lamblia

The Giardia lamblia Antigen Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of Giardia lamblia in human fecal specimens, as a screening test and as an aid in the diagnosis of Giardia lamblia infection.

Key Benefits:

  • Two band results for simple interpretation
  • Detects Giardia lamblia Antigen
  • Room temperature storage or refrigerated (2-30⁰C)
  • Internal control included

Specifications:

  • Specimen: Feces
  • Sensitivity: 96.7%, Specificity: 98.9%, Accuracy: 98.4%,
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Giardia lamblia Rapid Test
Feces
GCGIA-602a
Cassette/
20 Tests/Kit
CE-IVDD
The Giardia lamblia Antigen Rapid Test is not available for sale in the US. For EU and other countries, please contact us for more information.

Leishmania

The Leishmania Ab Rapid Test is a rapid lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of the Leishmania donovan (L. donovani), the Visceral leishmaniasis causative protozoans, in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis.

Key Benefits:

  • Two band results for simple interpretation
  • Detects both anti-L. donovani IgG and IgM
  • Internal control included
  • Reagents included
  • Room temperature storage or refrigerated (2-30⁰C)

Specifications:

  • Sensitivity: 98.4%
  • Specificity: 99.6%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 15 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Leishmania Antibody Rapid Test
S/P
GCKal-301a
Strip
/
50 Tests/Kit
/
Leishmania Antibody Rapid Test
S/P
GCKal-302a
Cassette
/
25 Tests/Kit
/
Leishmania Antibody Rapid Test
WB/S/P
GCKal-401a√
Strip
/
50 Tests/Kit
CE-IVDD
Leishmania Antibody Rapid Test
WB/S/P
GCKal-402a
Cassette/
25 Tests/Kit
/
Leishmania Antibody Rapid Test
WB/S/P
GCKal-T402a
Cassette/
25 Tests/Kit
CE-IVDD
The Leishmania Ab Rapid Test is not available for sale in the US. For EU and other countries, please contact us for more information. S: Serum, P: Plasma, WB: Whole Blood

Brucella

The Brucella Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) anti-Brucella in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Brucella.

Key Benefits:

  • Facilitates patient treatment decisions quickly
  • Simple, time-saving procedure
  • Rapid diagnosis
  • Reliable results

Specifications:

  • Sensitivity: 96.0%, Specificity: 98.4%, Accuracy: 98.0%,
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Brucella Antibody Rapid Test
WB/S/P
GCBRU-402a√
Cassette
/
25 Tests/Kit
CE-IVDD
Brucella IgG/IgM Rapid Test Cassette
WB/S/P
GCBRU(IgG/IgM)-402a
Cassette
/
25 Tests/Kit
CE-IVDD
The Brucella Antibody Rapid Test is not available for sale in the US. For EU and other countries, please contact us for more information. S: Serum, P: Plasma, WB: Whole Blood

Malaria

The Malaria Rapid Test is a rapid lateral flow chromatographic immunoassay for the detection and differentiation of Malaria P. falciparum specific histidine rich protein-2 (Pf HRP-II), pLDH (Plasmodium lactate dehydrogenase) specific to Plasmodium species (Pan), Malaria P. vivax specific lactate dehydrogenase (Pv-LDH) and antibodies including IgG, IgM and IgA to P. falciparum (Pf) and P. vivax (Pv) in human blood specimen as an aid in the diagnosis of Malaria infection.

Key Benefits:

  • Rapid results seen in 15 minutes
  • Requires a small blood sample easily collected by fingerstick
  • Differentiated results allow diagnosis of potentially lethal P. falciparum infection
  • Easy to read, objective, qualitative results

Specifications:

  • Sensitivity: Pf Ag 100%; Pv Ag 100%
  • Specificity: Pf Ag 98.7%; Pv Ag 98.7%
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 20 minutes
  • Shelf Life: 24 months from the date of manufacture

Ordering Information:

Product DescriptionSpecimenCatalog No.FormatCut-off ValueKit SizeRegulatory Clearance
Malaria Pan Antigen Test
WB
GCMAL(pan)-402a
Cassette
200 parasites
25 Tests/Kit
CE-IVDD
Malaria P.f. Antigen Test
WB
GCMAL(pf)-402a
Cassette
200 parasites
25 Tests/Kit
CE-IVDD
Malaria P.f. Antigen Test
WB
GCMAL(pf/pan)-402a-DR
Cassette
/
25 Tests/Kit
CE-IVDD
Malaria Pf/Pan Antigen Test
WB
GCMAL(pf/pan)-402a
Cassette
200 parasites
25 Tests/Kit
CE-IVDD
Malaria P.f./P.v. Antigen Test
WB
GCMAL(pf/pv)-402a
Cassette
200 parasites
25 Tests/Kit
CE-IVDD
Malaria P.f./P.v. Antibody Test
S/P
GCMAL(pf/pv Ab)-302a
Cassette
/25 Tests/Kit
CE-IVDD
Malaria P.f./P.v. Antibody Test
WB/S/P
GCMAL(pf/pv Ab)-402a
Cassette
/25 Tests/Kit
CE-IVDD
The Malaria Rapid Test is not available for sale in the US. For EU and other countries, please contact us for more information. S: Serum, P: Plasma, WB: Whole Blood