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Catalogue Biosynex 2016 Vus A4
Catalogue Biosynex 2016 Vus A4
04 Bacteriology
Microbiology 11 Cardiology
Inflammatory markers
04. Group A streptococcus bacterial infection 11. Cardiology
Antibiogram M.H. & U.U Inflammatory markers
Chlamydia trachomatis
Clostridium difficile
12
Helicobacter pylori
05. Legionella
Toxicology
Lyme disease
Syphilis 12. Drugs in urine :
Tetanus DRUGCHECK range
Group B streptococcus
Streptococcus pneumoniae 13. Drugs in urine :
DRUGCHECK Sure’Cup range
Drugs in saliva :
06
DRUGCHECK TUBE saliva
Virology Drugs in urine : DIMA range
14
06. Epstein-Barr virus
Respiratory viruses
Dengue virus
Cancer markers
07. Gastro-intestinal infections 14. Cancer markers
Hepatitis
Human Immunodeficiency Virus
15 Hormonology
08 Parasitology Obstetrics
Mycology 15. hCG
Premature Rupture Of Membranes
08. Concentration of parasitic elements (PROM)
Malaria Vaginal pH
Candida albicans
Cryptococcus PS
09.
Celiac disease
Rheumatoid Arthritis
16 Veterinary diagnostics
10 Biochemistry
2 SUMMARY
BLOTS & PCR
17 Bacteriology
28 AMPLIX
Real time PCR
17. Chlamydiae 28. The solutions
Whooping cough
Lyme disease 29. Nucleic acids automated extractors
Campylobacter Real time thermocyclers
19 Virology
20. Parvovirus
Rubella
21 Parasitology
23. Toxoplasmosis
21 Auto-immunity
INSTRUMENTS
22 Instruments
Accessories
22. Range of automated systems for
ImmunoLine & ImmunoBlot
27. Shakers
Reader for the erythro-sedimentation rate
SUMMARY 3
RDT : Bacteriology - Microbiology
1030007 - BIOSYNEX® MYCOPLASMA 20 galleries / kit 18 months M.H. ≥ 104 Myco/ml - U.U. ≥ 104 Myco/ml 24 h.
Chlamydia trachomatis
Direct detection of Chlamydiae trachomatis from female endocervical swabs and
male urethral swabs and urine samples.
Clostridium difficile
Detection of glutamate dehydrogenase (GDH) produced by Clostridium difficile or
Enterotoxin A and Cytotoxin B (Tox A&B) in faeces.
Helicobacter pylori
Detection of Helicobacter pylori antigen in faecal samples (Ag) or of specific
antibodies (Ab) of Helicobacter pylori in human serum, whole blood or plasma
1030010 - PYLORITOP® Ab
Detection of specific antibodies (Ab) of Helicobacter pylori. 25 devices / kit 24 months Sensitivity : 93,85 % - Specificity : 81,18 % 5 min.
Legionella
Lyme disease
Detection of specific total antibodies against the species of Borrelia burgdorferi in
serum (Blot Lymecheck® also available, see page 17).
Syphilis
Detection of antibodies against Treponema pallidum or of anti-lipoidal antibodies
W
(reaginic antibody) developing during syphilis.
NE
1030013 - TPHACHECK®
Treponema pallidum haemagglutination test for the detection of
the antibodies of syphilis in serum or Cerebro-Spinal Fluid (CSF). 96 wells / kit 18 months Sensitivity : 99,6 % - Specificity : 98,5 % 45 min.
1 positive control and 1 negative control included.
Group 2 classification
1030015 - VDRLCHECK®
RPR card test for the detection of reaginic antibodies in serum. 13 cards
12 months Sensitivity : 100 % - Specificity : 100 % 8 min.
1 positive control and 1 negative control included. 100 reactions / kit
Group 1 classification
Tetanus
Detection of anti tetanus toxin antibodies in human serum, plasma or whole blood.
Group B streptococcus
1030006 - BIOSYNEX® Strep B 20 devices / kit 12 months Between 1.0 x 105 and 2.0 x 105 bacteria/swab 15 min.
Streptococcus pneumoniae
1 positive control included. 20 devices / kit 12 months Cut-off : 0,25 ng/mL 15 min.
Epstein-Barr virus
Detection of the heterophilic antibodies of infectious mononucleosis and of specific
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antibodies in whole blood, serum and plasma.
NE
Respiratory viruses
Detection of Influenza type A and type B viruses and of the respiratory syncytial virus
antigen (RSV) in nasopharyngeal swab, nasopharyngeal wash or nasal aspirate spe-
cimens.
Reference - Designation Packaging Shelf-life Cut-off / Performance Results
1150005 - INFLUENZATOP®
Detection of Influenza type A and B viruses. 10 devices / kit 18 months A : 4,68 ng/mL - B : 4,68 ng/mL 10 min.
1 positive control (to A&B) included.
1150006 - RSVTOP®
Detection of RSV. 10 devices / kit 12 months 50 ng/mL 10 min.
1 positive control included.
Dengue virus
Detection of IgG and IgM anti-dengue antibodies or dengue NS1 antigen in human
serum, plasma and whole blood.
Gastro-intestinal infections
Detection in stool samples of Norovirus, Adenovirus, and Rotavirus, separately or
combined.
W
NE
Reference - Designation Packaging Shelf-life Cut-off / Performance Results
1150010 - IMMUNOQUICK® Norovirus
Detection of Group I and II norovirus. 10 devices / kit 12 months Sensitivity : 95,65 % - Specificity : 91,67 % 15 min.
1150011 - BIOSYNEX Adenovirus ®
Detection of adenovirus. 25 devices / kit 24 months Sensitivity : 99,9 % - Specificity : 99,4 % 10 min.
1150012 - BIOSYNEX Rotavirus ®
Detection of rotavirus. 25 devices / kit 24 months Sensitivity : 99,1 % - Specificity : 99,9 % 10 min.
Hepatitis
Detection of IgM antibodies to Hepatitis A virus (HAV) in serum, 10 devices / kit 18 months 20 mIU/mL 15 min.
plasma and whole blood.
1150017 - HEVTOP®
Detection of IgM antibodies to Hepatitis E virus (HEV) in serum and 10 devices / kit 18 months 20 mIU/mL 15 min.
plasma.
1150004 - BIOSYNEX® HIVTOP 25 devices / kit 18 months Sensitivity : 99,9 % - Specificity : 99,5 % 10 min.
Ecological solution. ParaFix and Bailenger techniques. 50 filters / kit 12 months Filter parasite concentrator 10 min.
1120003 - BIOSYNEX® Paracheck
Mif and Bailenger techniques. 50 filters / kit 12 months Filter parasite concentrator 10 min.
Malaria
Detection of the 4 types of Plasmodium : P. falciparum, P. vivax, P. ovale and P. malaria
W in whole blood.
NE
Candida albicans
Cryptococcus PS
Detection of polysaccharide antigens of several species of cryptococcus in serum,
plasma, CSF and urine.
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NE
1120001 - BIOSYNEX® CryptoPS 20 devices / kit 12 months Sensitivity : 95 % - Specificity : 100 % 10 min.
Celiac disease
1020001 - BIOSYNEX® Celiac 12 devices / kit 12 months Sensitivity : 95,1 % - Specificity : 97,2 % 5 min.
Rheumatoid Arthritis
Detection of Rheumatoid Arthritis specific autoantibodies (anti-CCP) in human
serum, plasma or capillary whole blood.
Glucose, protein, pH, occult blood, ketones. 100 strips / kit 18 months Semi-quantitative reading 60 to 90 sec.
1040008 - URITOP+®7
Glucose, protein, pH, occult blood, nitrite, densité (SG), 100 strips / kit 18 months Semi-quantitative reading & qualitative reading 60 to 90 sec.
leucocytes.
1040009 - URITOP+®10
Glucose, protein, pH, occult blood, ketones, nitrite, specific gravity 100 strips / kit 18 months Semi-quantitative reading & qualitative reading 60 to 90 sec.
(SG), leukocytes, bilirubin, urobilinogen.
1040010 - URITOP+®11
Glucose, protein, pH, occult blood, ketones, nitrites, specific 100 strips / kit 18 months Semi-quantitative reading & qualitative reading 60 to 90 sec.
gravity (SG), leukocytes, bilirubin, urobilinogen, ascorbic acid.
1040011 - URITOP+®13
Glucose, protein, pH, occult blood, ketones, nitrite, specific gravity 100 strips / kit 18 months Semi-quantitative reading & qualitative reading 60 to 90 sec.
(SG), leukocytes, bilirubin, urobilinogen, ascorbic acid,
microalbumin, creatinin.
Micro-albumin
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Qualitative or semi-quantitative detection of albumin in human urine samples.
NE
Cardiology
Detection of the cardiac marker Troponin I (cTnl), in serum, plasma or whole blood.
Inflammatory markers
Detection of CRP (C-reactive protein) or of Procalcitonin (PCT) in case of bacterial
infections, in whole blood, serum and plasma.
W
NE
Drugs in urine
1140016 - DRUGCHECK® 11
Detection of AMP, BAR, BZO, COC, MDMA, MET, MOP, MTD, TCA, 8 devices / kit 18 months See individual performances 5 min.
THC and BUP.
Drugs in urine
Drugs in saliva
Drugs in urine
NE
W Detection of drugs and their metabolites (1 can with 25 strips).
Cancer markers
Detection of cancer markers for the screening of colorectal cancers (faecal occult
blood : FOB), prostate cancer (PSA : Prostate Specific Antigen) or bladder cancer
(Bladder Tumor Antigen).
Detection of human hemoglobine in human stool specimens (FOB). 20 devices / kit 18 months 20 µg Hb/g (200 ng/mL) 5 min.
1110002 - HEMOTRUST®
Detection of human hemoglobine in human stool specimens (FOB). 25 devices / kit 18 months 6 µg Hb/mL (50 ng/mL) 5 min.
1110003 - BIOSYNEX® FOB Expert
Detection of human hemoglobine in human stool specimens (FOB).
25 individual patient books included (information for stool NE
W 25 devices / kit 18 months 6 µg Hb/mL (50 ng/mL) 5 min.
collection, stool collection tube, and stool collection paper).
hCG
Detection of IGFBP-1 (Insuline-like Growth Factor Binding Protein 1). 10 devices / kit 12 months 5 ng/mL 10 min.
1090003 - AMNIOQUICK®
Detection of IGFBP-1 (Insuline-like Growth Factor Binding Protein 1). 10 strips / kit 12 months 5 ng/mL 10 min.
1090004 - AMNIOQUICK® Duo+
Detection of IGFBP-1 (Insuline-like Growth Factor Binding Protein 1) 10 devices / kit 12 months IGFBP-1 : 10 ng/mL - AFP : 5 ng/mL 10 min.
and AFP (Alpha-fetoprotein).
vaginal pH
4030002 - Lyme Ab
Detection of specific total antibodies against the species of Borrelia NE
W 10 devices / kit 12 months Sensitivity : 93 % - Specificity : 98 % 10-15 min.
burgdorferi in canine serum, whole blood or plasma.
4120003 - CHW Ag
Detection of canine Dirofilaria immitis (heartworm) antigens in NE
W 10 devices / kit 12 months Sensitivity : 94,4 % - Specificity : 100 % 5-10 min.
canine whole blood, plasma or serum.
Other available references : BTB Ab, C. Brucella Ab, CCV Ag, CDV Ab, CDV Ag, CPV/CCV Ag,
Ehrlichia Canice, Felv Ag, FMDVCHECK®, FPV Ag (feline Panleukopenia), Giardia Ag, H5 AIV Ag,
IBD Ag, n NDV Ag, PED Ag, Rabies Ag, Rotavirus Ag, TGE Ag, TGE/PED Ag.
Chlamydiae
Whooping cough
For the determination of IgG or IgA antibodies against Bordetella pertussis in human
serum or plasma.
2030004 - BORDETELLACHECK® Optima IgA 20 strips / kit 12 months Sensitivity : 97,1 % - Specificity : 96,6 % 2 h. 15
Lyme disease
For the determination of IgG or IgM antibodies against Borrelia burgdorferi sensu
lato (5 species : B. sensu strictu, B. garinii, B. afzelii, B. bavariensis and B.spielmanii)
in human serum, plasma or cerebrospinal fluid (Rapid test Lymetop® also available,
see page 5).
Reference - Designation Packaging Shelf-life Cut-off / Performance Results
2030005 - LYMECHECK® Optima IgG & IgM 20 strips / kit 12 months Sensitivity : 99,5 % - Specificity : 96 % 2 h. 15
Campylobacter
For the determination of IgG or IgA antibodies against Campylobacter jejuni and
Campylobacter coli in human serum or plasma.
6272 - recomLine® Campylobacter IgG 20 strips / kit 12 months According to antigens, see evaluation 2 h. 15
6273 - recomLine® Campylobacter IgA 20 strips / kit 12 months According to antigens, see evaluation 2 h. 15
Helicobacter pylori
For the determination of IgG or IgA antibodies against Helicobacter pylori in human
serum or plasma.
4772 - recomLine® Helicobacter IgG 20 strips / kit 12 months Sensitivity : 96,4 % - Specificity : 100 % 2 h. 15
4773 - recomLine® Helicobacter IgA 20 strips / kit 12 months Sensitivity : 69,2 % - Specificity : 100 % 2 h. 15
Treponema pallidum
5172 - recomLine® Treponema IgG 20 strips / kit 12 months Sensitivity : 100 % - Specificity : 98,5 % 2 h. 15
5173 - recomLine® Treponema IgM 20 strips / kit 12 months Sensitivity : 100 % - Specificity : 98,5 % 2 h. 15
Yersinia
For the determination of IgG or IgA (*IgM) antibodies against Yersinia enterocolitica
and Yersinia pseudotuberculosis in human serum or plasma.
4672 - recomLine® Yersinia IgG 20 strips / kit 12 months Comparison with 2 techniques, see evaluation 2 h. 15
4673 - recomLine® Yersinia IgA (*IgM)
(*IgM conjugate réf 2060003, 500 μL vial, to be used with réf 4673) 20 strips / kit 12 months Comparison with 2 techniques, see evaluation 2 h. 15
For the determination of IgM antibodies against Epstein Barr virus. 20 strips / kit 12 months Sensitivity : 99 % - Specificity : 99 % 2 h. 15
5502 - recomLine® CMV IgG
For the determination of IgG antibodies against Cytomegalovirus. 20 strips / kit 12 months Sensitivity : 100% - Specificity : 98,4 % 2 h. 15
5503 - recomLine® CMV IgM
For the determination of IgM antibodies against Cytomegalovirus. 20 strips / kit 12 months Sensitivity : 100 % - Specificity : 96,9 % 2 h. 15
5372 - recomLine® HSV-1 & HSV-2 IgG
For the determination of IgG antibodies against Herpes simplex 20 strips / kit 12 months Sensitivity : 99,4 % - Specificity : 91,1 % 2 h. 15
virus of type 1 & 2.
Hepatitis
For the determination of IgG and/or IGM antibodies against E or C Hepatitis virus in
human serum or plasma.
For the detection of IgG antibodies against the human immunodeficiency viruses
(HIV-1 and HIV-2) in human serum or plasma.
6672 - recomLine® HIV1 & HIV2 IgG 20 strips / kit 12 months Sensitivity : 100 % - Specificity : 98,2 % 4 h. 15
Parvovirus
For the determination of IgG or IgM antibodies against Parvovirus B19 in human
serum or plasma.
4472 - recomLine® Parvovirus B19 IgG 20 strips / kit 12 months According to population, see evaluation 2 h. 15
4473 - recomLine® Parvovirus B19 IgM 20 strips / kit 12 months According to population, see evaluation 2 h. 15
Rubella
For the determination of IgG antibodies against Rubella virus in human serum or
plasma.
4902 - recomBlot® Rubella IgG 20 strips / kit 12 months Sensitivity : 93 % - Specificity : 100 % 11 h. à 17 h.
Toxoplasmosis
For the determination of IgG or IgM (*IgA) antibodies against Toxoplasma gondii in
human serum or plasma.
5972 - recomLine® Toxoplasma IgG 20 strips / kit 12 months Sensitivity : 100 % - Specificity : 94,1 % 2 h. 15
5973 - recomLine Toxoplasma IgM (*IgA)
® Sensitivity : 83,2 % - Specificity : 93,2 %
20 strips / kit 12 months 2 h. 15
(*IgA conjugate réf 2060001, 500 μL vial, to be used with ref 5973) Sensitivity : 100 % - Specificity : 96 %
BLOTS : Auto-immunity
Auto-immune pathogens
5120002 Cellscheck kit : 100 slides for 500 patients and related reagents.
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NE FLEXIREADER : Portable reader for rapid diagnostic tests.
Comes in a case containing : 1 FLEXIREADER device, 1 printer, 2 cassette
adapters and 1 control cassette.
• Read and interpret over 30 different references of BIOSYNEX rapid diagnostic tests
(HIV, DRUGCHECK range, crp ...).
• Automatic test identification.
5060003 • FLEXIREADER software to save, send and read results.
• Internal or external test incubation.
• Traceability: images and results are archived.
• Connectivity : printer, barcode reader, USB cable/stick.
• Optimised connectivity : Wifi, Bluetooth, results sent by email ...
• Touchscreen.
• Compact : 100 x 85 x 180 mm - Weight : 474 grs.
5060004 Printer.
5060005 Printer paper (kit of 10 rolls).
Biochemistry readers
Reference Description
CUBE READER : Reader for the quantitative determination of CRP and INR.
• Sample size (whole blood) : only 5 μL (CRP) and 20 μL (INR).
• Results in 3 minutes.
CA0100 • Power supply : batteries or adapter.
• Androïd software, Bluetooth, USB connection.
• Data transfer to printer or host.
• Dimensions : 160 x 230 x 145 mm - Weight : 2,4 kg.
Portable readers
Reference Description
Shakers
Reference Description
5060007 IPP-4 platform available for 4 microtest plates (266 x 170 mm).
Real-time PCR, by its sensitivity, specificity and speed, provides a powerful tool for medical diagnostic.
BIOSYNEX offers healthcare specialists three complete extraction and amplification PCR solutions adapted to private and
public medical analysis laboratories, hospital centers and clinics’ needs. Our extraction and amplification reagents are
ready-to-use and allow the detection, identification and quantification of a wide range of pathogens.
28 AMPLIX RT PCR
AMPLIX : real time PCR
AMPLIX RT PCR 29
AMPLIX : real time PCR
Amplification reagents
AMPLIX PCR kits include all reagents necessary for quality analysis :
- ready to use Mastermix,
- specific internal standard and positive control,
- patented anticontamination system.
AMPLIX PCR reagents are available in liquid or freezer-dried format and are validated and compatible on the majority of
real-time PCR detection systems :
- AmpliX NG48, AmpliX NG96 (BIOSYNEX),
- Rotor-Gene 3000/6000/Q (QIAGEN),
- LightCycler 2.0/480 (ROCHE),
- Applied Biosystems 7300/7500 Real-Time PCR System (Life Technologies),
- StepOneTM Real-Time PCR System (Life Technologies),
- SmartCycler (Cepheid),
- CFX96™ Real-Time PCR Detection System (Bio-Rad),
- SLAN Real-Time PCR System (Shanghai Hongshi Medical Technology Co., Ltd.),
- Mx3005P QPCR System (Agilent Technologies),
- qTower 2.0/2.2 (Analytik Jena AG).
30 AMPLIX RT PCR
AMPLIX : real time PCR
VETERINARY RANGE
3160001 Swine influenza virus 3160005 Bluetongue virus
3160002 Porcine circovirus 3160006 Infectious bovine rhinotracheitis virus
3160003 Porcine reproductive and respiratory syndrome virus 3160007 Bovine viral diarrhea virus
3160004 Classical swine fever virus 3160008 Foot and mouth disease virus
NOTES
AMPLIX RT PCR 31
32