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LIAISON®ANTI-HAV
310200
Intended Use
For the qualitative detection of total IgG and IgM antibodies to Hepatitis A virus
Material provided
Reagent integral for 100 determinations. Diluent included.
Method
2-step sandwich chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators
Included
Sample Type
Serum or Na+ Heparin plasma
Sample Size
80 µL
Comments
In Vitro Diagnostic Use
LIAISON®Control Anti-HAV
310201
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® HAV IgM
310210
Intended Use
For the qualitative detection of IgM antibodies to Hepatitis A virus
Material provided
Reagent integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic micropartles
Calibrators
Included
Sample Type
Serum or Na+ Heparin plasma
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control HAV IgM
310211
Material provided
Two levels x 2 vials each 15 determinations per vial
LIAISON® Rubella IgG
310460
Intended Use
For the qualitative determination of IgG antibodies to Rubella virus
Material provided
Reagent integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic micropartles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Rubella IgG Tri-Controls
310461
Material provided
Three levels x 2 vials each 15 determinations per vial
LIAISON® Rubella IgM
310730
Intended Use
For the qualitative determination of IgM antibodies to Rubella virus
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
Antibody capture immunoassay using coated magnetic microparticles
Calibrators
Included
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control Rubella IgM
310732
Material provided
Two levels x 2 vials each, 20 determinations total
LIAISON® Treponema Assay
310480
Intended Use
For the qualitative determination of total antibodies to Treponema pallidum
Material provided
Reagent Integral for 200 determinations. Diluent included
Method
1-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
30 minutes
Sample Type
Serum
Sample Size
70 µL
Comments
In Vitro Diagnostic Use
LIAISON® VZV IgG
310490
Intended Use
For the qualitative determinations of IgG antibodies to Varicella-Zoster Virus
Material provided
Reagent Integral for 50 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control VZV IgG
310491
Material provided
Two levels x 2 vials each 20 determinations per vial
LIAISON® EBV IgM
310500
Intended Use
For the qualitative determination of IgM antibodies to Epstein-Barr virus viral capsid antigen
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control EBV IgM
310501
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON®VCA IgG
310510
Intended Use
For the qualitative determination of IgG antibodies to Epstein-Barr Virus Viral Capsid Antigen (VCA)
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic mircroparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control VCA IgG
310511
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® EBNA IgG
310520
Intended Use
For the qualitative determination of IgG antibodies to Epstein-Barr Virus Nuclear Antigen (EBNA-1)
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic mircroparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control EBNA IgG
310521
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® EA IgG
310540
Intended Use
For the qualitative determination of IgG antibodies to Epstein-Barr Virus Early Antigen (Diffuse) [EA(d)]
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control EA IgG
310541
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® HSV-2 Type Specific IgG
310620
Intended Use
For the qualitative determination of type specific IgG antibodies to Herpes Simplex Virus Type 2 (HSV-2)
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
5 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control HSV-2 Type Specific IgG
310621
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® Toxo IgG II
310705
Intended Use
For the qualitative determination of IgG antibodies to Toxoplasma gondii
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control Toxo IgG II
310706
Material provided
Two levels x 2 vials each 24 determinations
LIAISON® Toxo IgM II
310715
Intended Use
For the qualitative determination of IgM antibodies to Toxoplasma gondii
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators
Included
Incubation
25 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control Toxo IgM II
310716
Material provided
Two levels x 2 vials each 24 determinations
LIAISON® CMV IgG
310740
Intended Use
For the qualitative determination of IgG antibodies to Cytomegalovirus
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control CMV IgG
310741
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® CMV IgM
310750
Intended Use
For the qualitative determination of IgM antibodies to Cytomegalovirus
Material provided
Reagent integral for 100 determinations. Diluent included.
Method
3-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators
Included
Incubation
30 minutes
Sample Type
Serum
Sample Size
20 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control CMV IgM
310751
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® HSV-1 Type Specific IgG
310830
Intended Use
For the qualitative determination of type specific IgG antibodies to Herpes Simplex Virus Type 1 (HSV-1)
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
10 µL
Comments
In Vitro Diagnostic Use
LIAISON® Control HSV-1 IgG
310831
Material provided
Two levels x 2 vials each 40 determinations per vial
LIAISON® Treponema Serum Controls
310842
Material provided
Two levels x 2 vials each 20 determinations per vial
LIAISON® Borrelia burgdorferi
310870
Intended Use
For the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi
Material provided
Reagent Integral for 100 determinations. Diluent included
Method
2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators
Included
Incubation
20 minutes
Sample Type
Serum
Sample Size
5 µL
Comments
In Vitro Diagnostic Use
LIAISON® Borrelia burgdorferi Serum Controls
310871
Material provided
Two levels x 2 vials each 40 determinations per vial
ETI-Measles IgG ELISA
4601/96 Wells
Intended Use
For the semi-quantitative detection of IgG antibodies to Measles Virus
Label
HRP
Incubation
30 min + 30 min + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:101 dilution
Comments
In Vitro Diagnostic Use
ETI-Varicella Zoster (VZV) IgG ELISA
4621/96 Wells
Intended Use
For the qualitative and semi-qualitative detection of IgG antibodies to Varicella Zoster Virus
Label
HRP
Incubation
30 min + 30 min + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:101 dilution
Comments
In Vitro Diagnostic Use
ETI-Mumps IgG ELISA
4631/96 Wells
Intended Use
For the qualitative and semi-quantitative determination of IgG antibodies to Mumps Virus
Label
HRP
Incubation
30 min + 30 min + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:21 dilution
Comments
In Vitro Diagnostic Use
ETI-H. pylori IgG
4651/96 Wells
Intended Use
For the qualitative determination of IgG antibodies to H. pylori antigen
Label
HRP
Incubation
30 min + 30 min + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:21 dilution
Comments
In Vitro Diagnostic Use
Cytomegalovirus (CMV) IgG ELISA
720-320/96 Wells
Intended Use
For the qualitative and semi-quantitative detection of IgG antibodies to Cytomegalovirus
Label
HRP
Incubation
60 + 60 + 20 min/37°C
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:101 dilution
Comments
In Vitro Diagnostic Use
Cytomegalovirus (CMV) IgM Capture ELISA
720-330/96 Wells
Intended Use
For the qualitative detection of IgM antibodies to CMV
Label
HRP
Incubation
60 + 60 + 20 min/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:101 dilution
Comments
In Vitro Diagnostic Use
HSV 1&2 IgG ELISA
720-340/96 Wells
Intended Use
For qualitative and semi-quantitative detection of IgG antibodies to HSV Type 1 and/or Type 2
Label
HRP
Incubation
60 min + 60 min + 20 min/37°C
Chromogen/Substrate
TMB
Sample Type
Serum
Sample Size
100 µL of 1:101 dilution
Comments
In Vitro Diagnostic Use
Ortho® HCV 3.0 ELISA
930740/480 Wells
Intended Use
For the detection of antibody to Hepatitis C Virus (anti-HCV)
Label
HRP
Incubation
1 hr/37°C + 1 hour/37°C + 30 min/RT
Chromogen/Substrate
OPD
Sample Type
Serum/Plasma
Sample Size
210 µL of 1:21 dilution
Comments
In Vitro Diagnostic Use
HBsAg Confirmatory PLUS
N0143/44 Tests
Intended Use
Confirmatory assay for Hepatitis B Surface Antigen (HBsAg)
Sample Type
Serum/Plasma
Comments
In Vitro Diagnostic Use
ETI-HA-IgMK PLUS (IgM anti-HAV)
P001925/96 Wells
Intended Use
For the detection of IgM antibodies to Hepatitis A virus
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
100 µL of 1:100 dilution
Comments
In Vitro Diagnostic Use
ETI-AB-HAVK PLUS (anti-HAV)
P001926/96 Wells
Intended Use
For the detection of total antibodies to Hepatitis A virus
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
50 µL
Comments
In Vitro Diagnostic Use
ETI-AB-COREK PLUS (anti-HBc)
P001927/192 Wells
Intended Use
For the detection of total antibodies to Hepatitis B core antigen (anti-HBc)
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
50 µL
Comments
In Vitro Diagnostic Use
ETI-CORE-IgMK PLUS (IgM anti-HBc)
P001928/96 Wells
Intended Use
For the detection of IgM antibodies to Hepatitis B core antigen (IgM anti-HBc)
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
100 µL of (1:4000) dilution
Comments
In Vitro Diagnostic Use
ETI-AB-EBK PLUS (anti-HBe)
P001929/96 Wells
Intended Use
For the detection of antibodies to Hepatitis B(e) antigen (AntiHBe)
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
50 µL
Comments
In Vitro Diagnostic Use
ETI-EBK PLUS (HBeAg)
P001930/96 Wells
Intended Use
For the detection of Hepatitis B(e) antigen (HBeAg)
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
100 µL
Comments
In Vitro Diagnostic Use
ETI-AB-AUK PLUS (anti-HBs)
P001931/192 Wells
Intended Use
For the detection of antibodies to Hepatitis B surface antigen (anti-HBs)
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
100 µL
Comments
In Vitro Diagnostic Use
ETI-MAK-2 PLUS (HBsAg)
P001932/192 Wells
Intended Use
For the detection of Hepatitis B surface antigen (HBsAg)
Label
HRP
Incubation
2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate
TMB
Sample Type
Serum/Plasma
Sample Size
100 µL
Comments
In Vitro Diagnostic Use
Anti-HBs Quant AB AU Standard Set
P001936
Intended Use
Standard set anti-HBs (5-160 mIU/mL; WHO 1st reference preparation 1977)
Sample Type
Serum/Plasma
Comments
ASR: Analyte Specific Reagent analytical and performance characteristics are not established. Not for donor screening
TREP-SURE™ Syphilis Screen
TS96/96 Wells
Intended Use
For the in vitro diagnostic detection of (Treponema pallidum) Antibodies (Syphilis)
Label
HRP
Incubation
60 min + 30 min + 15 min/37°C
Chromogen/Substrate
TMB
Sample Type
Serum or EDTA and Citrated Plasma
Sample Size
100 µL
Comments
In Vitro Diagnostic Use
LIAISON® QuantiFERON® -TB Gold Plus
311020
Intended Use
The LIAISON® QuantiFERON®-TB Gold Plus assay is an in vitro diagnostic test for the detection of interferon-γ (IFN-γ) in human lithium heparin plasma by chemiluminescence immunoassay (CLIA) using the LIAISON® XL Analyzer. QIAGEN QuantiFERON®-TB Gold Plus Blood Collection Tubes, containing a peptide cocktail simulating ESAT-6 and CFP-10 proteins, are used in conjunction with the LIAISON® QuantiFERON®-TB Gold Plus assay to stimulate cells in heparinized whole blood. Detection of IFN-γ is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. The assay is a qualitative indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations to assist the clinician in making individual patient management decisions. The LIAISON® QuantiFERON®-TB Gold Plus assay must be performed using the LIAISON® XL Analyzer.
Material provided
Reagent integral for 200 determinations, 50 patients
Method
Direct sandwich: monoclonal antibodies to IFN-γ coated on magnetic particles and monoclonal antibodies to IFN-γ linked to an isoluminol derivative isoluminol-antibody conjugate
Calibrators
Included, lyophilized
Sample Type
Human Lithium Heparin Plasma (QIAGEN QuantiFERON®-TB Gold Plus Blood Collection Tubes)
LIAISON® Control QuantiFERON® -TB Gold Plus
311021
Intended Use
The LIAISON® Control QuantiFERON®-TB Gold Plus is intended for use as assayed quality control samples to monitor the performance of the LIAISON® QuantiFERON®-TB Gold Plus assay. The performance characteristics of LIAISON® Control QuantiFERON®-TB Gold Plus have not been established for any other assays or instrument platforms other than LIAISON® XL Analyzer.
Material provided
Control level 1 (lyophilized, 2 x 2.0 mL); Control level 2 (lyophilized, 2 x 2.0 mL)
LIAISON® SARS-CoV-2 S1/S2 IgG
311460
Intended Use
For qualitative determination of anti-S1 and anti-S2 specific IgG antibodies to SARS-CoV-2
Material provided
Reagent Integral for 110 determinations.
Method
Indirect chemiluminescence immunoassay (CLIA)
Calibrators
Included
Sample Type
Serum or plasma
LIAISON® SARS-CoV-2 S1/S2 IgG Control set
311461
Material provided
Sufficient for 40 determinations
Sample Type
Serum or plasma
