Laboratory Diagnostics Products
A rapid one step test device for testing combinations of the following drugs: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Phencyclidine, and Tricyclic Antidepressant.
This test will detect other related compounds, please refer to the Analytical Specificity table in the package insert. This assay provides only a preliminary analytical test result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Rapid immunoassay
25 tests
Qualitative detection of multiple drugs and drug metabolites in human urine.
Canada Cleared, Not FDA Cleared, Not CE Cleared
The Trinity Biotech Captia™ Herpes Simplex Virus type 2 (HSV 2) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro semi-quantitative determination of IgM antibodies in human serum to Herpes simplex type 2 virus and as an aid in the diagnosis of herpes related diseases. High complexity test.
96 Tests/480 Tests
Infectious Diseases, Virology, Sexual Health, ToRCH
FDA: Not Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
The Trinity Biotech Captia™ Epstein-Barr Virus Capsid Antigen (EBV VCA) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies to Epstein-Barr virus in human serum. The Trinity Biotech anti-EBV VCA IgG assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis in the adult population. For in vitro diagnostic use. High complexity test.
96 Tests
Infectious Diseases, Virology
FDA: Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
The Trinity Biotech Captia™ Cytomegalovirus (CMV) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibody to cytomegalovirus in human serum. For in vitro diagnostic use. High complexity test.
96 Tests
Infectious Diseases, Virology, ToRCH
FDA: Cleared
Canada: Cleared
CE: Not Marked
The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro determination of Measles IgM antibodies in human serum. For in vitro diagnostic use. High complexity test.
96 Tests
Infectious Disease, Virology, MMRV
ELISA
FDA: Not Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
This device is intended for an indirect immunofluorescence antibody test for the detection and quantitation of antibodies to native (double stranded) deoxyribonucleic acid (nDNA) in human serum
IFA
48
Systemic Lupus Erthematosus (SLE)
FDA: Cleared
CE:Marked
Canada: Cleared
IFU Documents
SDS Documents
This device is intended for the screening and detection by indirect immunofluorescence (IF) of primarily anti-myelin associated glycoproteins (anti-MAG) and other glycolipid autoantibodies in human serum.
Provides 48 determinations
Autoimmune Neuropathies
FDA: Not Cleared
CE: Marked
Canada: Not Cleared
This device is intended for an indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-reticulin antibodies (ARA) in human serum.
Provides 240 determinations
Celiac, Dermatitis Herpetiformis
FDA: Not Cleared
CE: Marked
Canada: Not Cleared
SDS Documents
This device is intended for an indirect immunofluorescence antibody test for the detection and quantitation of anti-skin (anti-intercellular and anti-basement membrane) antibodies in human serum.
Provides 48 determinations
Vesiculo-bullous, Paraneoplastic Syndromes
FDA: Cleared
CE: Marked
Canada: Cleared
This device is intended for an indirect immunofluorescence antibody test for the qualitative and semi-quantitative detection of endomysial antibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis
Provides 48 determinations
Celiac Disease
FDA: Not Cleared
CE: Marked
Canada: Not Cleared
Provides 48 determinations
FDA: Not Cleared
CE: Marked
Canada: Cleared
The device is intended for indirect immunofluorescence (IF) antibody tests for the detection and quantitation of antinuclear antibodies (ANA) in human serum.
Provides 60 determinations
Dermato/Polymyositis, Rheumatoid Artfitis, Scleroderma, Sjogrns Syndrome, Systematic Lupus Erythematosus (SLE)
FDA: Cleared
CE: Marked
Canada: Not Cleared
The Captia™ Syphilis Total Antibody EIA kits is intended for use by appropriately trained and qualified personnel for the detection of antibodies to Treponema pallidum in human serum and plasma. The product may be used for the screening of blood donors, the screening of pregnant women, and to aid in the diagnosis of patients where syphilis infection is suspected.
96 Tests/480 Tests
Infectious Diseases, Bacteriology, Sexual Health, Blood Donor Screening
FDA: Not Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
The Captia™ NMT Syphilis IgM EIA is intended for the detection of IgM specific antibodies to Treponema pallidum (T. pallidum) in human serum or plasma and is used in the differential diagnosis of syphilis infections.
96 Tests
Infectious Diseases, Bacteriology, Sexual Health
FDA Not Cleared,
Canada Not Cleared,
CE Marked
Enzyme linked immunoassays (ELISA) for the detection and semi-quantitation of SS-B (La) antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and associated connective tissue disorders.
Special Order
EIA
96
Sjögren’s Syndrome, Systemic Lupus Erythematosus (SLE)
FDA: Cleared
Canada: Not Cleared
CE Marked
The Captia™ Malaria Total Antibody EIA is intended for use by appropriately trained and qualified personnel for the qualitative and semi-quantitative detection of antibodies to P.falciparum, P.vivax, P.ovale and P.malariae in human serum and plasma.
96 Tests/480 Tests
Infectious Diseases
FDA: Not Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
A rapid, one step screening test for the, qualitative detection of Fentanyl and Fentanyl metabolites in human urine.
lateral flow chromatographic immunoassay
40 tests
qualitative detection of Fentanyl and Fentanyl metabolites
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, Confirm 5 HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, Confirm 5 HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
20 ml
Drugs of abuse, GC/MS MIX
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
20 ml
Drugs of abuse, Pain MGMT
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
20 ml
Drugs of abuse, Pain MGMT
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, GC/MS HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, GC/MS HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, GC/MS HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, GC/MS LOW OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, GC/MS LOW OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, GC/MS LOW OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, Confirm 4 HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, Confirm 4 HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, Confirm 4 HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, Confirm 4 HIGH OPIATE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
5 ml
Drugs of abuse, Immunoassay Urine Toxicology
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
50 ml
Drugs of abuse, NEGATIVE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
5 ml
Drugs of abuse, NEGATIVE
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
5 ml
Drugs of abuse, Immunoassay Urine Toxicology
Canada Cleared, Not FDA Cleared, Not CE Cleared
DOA URINE TOXICOLOGY LIQUID CONTROL, Positive, Fentanyl (norfentanyl). The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
5 ml
Drugs of abuse, Immunoassay Urine Toxicology
Canada Cleared, Not FDA Cleared, Not CE Cleared
The DOA Urine Toxicology Controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. Each bottle contains stabilized human based urine.
qualitative or quantitative procedures for the detection of drugs in urine
5 ml
Drugs of abuse, Immunoassay Urine Toxicology
Canada Cleared, Not FDA Cleared, Not CE Cleared
A rapid, one step test for the qualitative detection of Buprenorphine in human urine
lateral flow chromatographic immunoassay
40 tests
detection of Buprenorphine
Canada Cleared, Not FDA Cleared, Not CE Cleared
A rapid one step test device for testing combinations of the following drugs: Amphetamine, Barbiturates,
Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, and Tricyclic Antidepressants.
This test will detect other related compounds, please refer to the Analytical Specificity table in the package insert. This assay provides only a preliminary analytical test result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Rapid immunoassay
25 tests
Qualitative detection of multiple drugs and drug metabolites in human urine.
Canada Cleared, Not FDA Cleared, Not CE Cleared
The N.C.S. hCG negative control – urine is intended to validate the performance of qualitative urinary hCG methods.
intended to validate the performance of qualitative urinary hCG methods
5 ml
PREGNANCY HCG
Canada Cleared, Not FDA Cleared, Not CE Cleared
The N.C.S. hCG positive control – urine is intended to validate the performance of qualitative urinary hCG methods. Low Positive control 25mIU/mL
intended to validate the performance of qualitative urinary hCG methods
5 ml
PREGNANCY HCG
Canada Cleared, Not FDA Cleared, Not CE Cleared
The hCG One Step Pregnancy Test device (urine/serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.
Rapid immunoassay
50 tests
early detection of pregnancy
Canada Cleared, Not FDA Cleared, Not CE Cleared
The hCG One Step Pregnancy Test device (urine/serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.
Rapid immunoassay
25 tests
early detection of pregnancy
Canada Cleared, Not FDA Cleared, Not CE Cleared
The hCG One Step Pregnancy Test device (urine/serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.
Rapid immunoassay
500 tests
early detection of pregnancy
Canada Cleared, Not FDA Cleared, Not CE Cleared
The hCG One Step Pregnancy Test device (urine/serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.
Rapid immunoassay
100 tests
early detection of pregnancy
Canada Cleared, Not FDA Cleared, Not CE Cleared
The hCG One Step Pregnancy Test device (urine/serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.
Rapid immunoassay
40 tests
early detection of pregnancy
Canada Cleared, Not FDA Cleared, Not CE Cleared
Rapid Test For Malaria Pan/Pf is a rapid, qualitative, two site sandwich immunoassay, utilizing whole blood for the detection of P.falciparum specific histidine rich protein-2 (Pf HRP-2) and Pan malaria specific pLDH. The test may also be used for differentiation of P. falciparum and other malarial species and for the follow up of antimalarial therapy in whole blood samples.
Rapid immunoassay
10 tests
Malaria Pan/Pf
Canada Cleared, Not FDA Cleared, Not CE Cleared
Rapid Test For Malaria Pan/Pf is a rapid, qualitative, two site sandwich immunoassay, utilizing whole blood for the detection of P.falciparum specific histidine rich protein-2 (Pf HRP-2) and Pan malaria specific pLDH. The test may also be used for differentiation of P. falciparum and other malarial species and for the follow up of antimalarial therapy in whole blood samples.
Rapid immunoassay
25 tests
Malaria Pan/Pf
Canada Cleared, Not FDA Cleared, Not CE Cleared
Test kit component
Rapid immunoassay
4 ml
Malaria Pan/Pf
Canada Cleared, Not FDA Cleared, Not CE Cleared
Test kit component
Rapid immunoassay
4 ml
Plasmodium falciparum malaria
Canada Cleared, Not FDA Cleared, Not CE Cleared
Rapid test for P. falciparum malaria-Device is a rapid, qualitative, two site sandwich immunoassay for the determination of P. falciparum specific histidine rich protein-2 (Pf HRP-2) in whole blood for the diagnosis of falciparum malaria in individuals with signs and symptoms consistent with malaria infection
Rapid immunoassay
25 tests
Plasmodium falciparum malaria
Canada Cleared, Not FDA Cleared, Not CE Cleared
Rapid test for P. falciparum malaria-Device is a rapid, qualitative, two site sandwich immunoassay for the determination of P. falciparum specific histidine rich protein-2 (Pf HRP-2) in whole blood for the diagnosis of falciparum malaria in individuals with signs and symptoms consistent with malaria infection
Rapid immunoassay
10 tests
Plasmodium falciparum malaria
Canada Cleared, Not FDA Cleared, Not CE Cleared
IFA
6 wells
FDA Not Cleared, CE Marked Canada Not Cleared
The MONO Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood, serum or plasma as an aid in the diagnosis of Infectious Mononucleosis.
Rapid immunoassay
20 tests
Canada Cleared, Not FDA Cleared, Not CE Cleared
IFA
8 wells
FDA Cleared, CE Marked Canada Not Cleared
IFA
4 wells
FDA Not Cleared, CE Marked Canada Cleared
IFA
6 wells
FDA Cleared, CE Marked Canada Not Cleared
IFA
6 wells
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
6 wells
FDA: Not Cleared
CE: Marked
Canada: Not Cleared
IFA
8 wells
FDA Cleared, CE Marked Canada Cleared
IFA
12 wells
FDA Cleared, CE Marked Canada Cleared
IFA
6 wells
FDA Not Cleared, CE Marked Canada Cleared
IFA
6 wells
FDA Not Cleared, CE Marked Canada Cleared
IFA
6 wells
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA: Cleared
CE: Marked
Canada: Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared
CE Marked
Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
5 x 0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
60 ml
FDA Cleared, CE Marked Canada Cleared
IFA
For 1 litre
FDA: Cleared
CE: Marked
Canada: Cleared
IFA
5 ml
FDA Cleared, CE Marked Canada Cleared
