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BIOSYNEX
INTERNATIONAL CATALOGUE 2019

INTERNATIONAL CATALOGUE 2019

Product catalog summary

Overview: The document is an international catalogue from BIOSYNEX, a French leader in rapid diagnostic tests (RDT), detailing their offerings for 2020. It covers various diagnostic areas including bacteriology, molecular biology, parasitology, mycology, virology, biochemistry, oncology, women's health, immunology, and instruments.

Company Profile: BIOSYNEX focuses on designing, developing, and offering innovative health solutions. They emphasize a strong entrepreneurial culture, innovation, quality, and customer satisfaction. The company is certified with EN ISO 9001:2015 and EN ISO 13485:2016, and holds CE certificates.

Contact Information: The catalogue provides contact details for different geographical areas: North Area (North America, Europe, North Asia), South Area (Central and South America, Middle East, South East Asia, Oceania), and African Area, along with customer service contacts.

Product Categories:

Bacteriology: Includes RDTs for Chlamydia trachomatis, Clostridium difficile, Clostridium tetani, Helicobacter pylori, Legionella pneumophila, Streptococcus, and Treponema pallidum.
Molecular Biology (PCR): Covers tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Gardnerella vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Treponema pallidum, and more.
Parasitology: RDTs and PCR tests for malaria and other parasitic infections.
Mycology: Tests for cryptococcosis, candidiasis, and aspergillosis.
Virology: RDTs and PCR tests for viruses such as Epstein-Barr, dengue, respiratory infections, gastrointestinal infections, hepatitis, HIV, and more.
Biochemistry and Oncology: Includes tests for toxicology, urinary strips, colorectal cancer, bladder tumor antigen, CRP, PSA, cardiac markers, and hemostasis.
Women's Health: Tests related to obstetrics and hormonology.
Immunology: Tests for celiac disease and rheumatoid factors.
Instruments: Includes rapid test readers, strip readers, molecular biology instruments, and stainer instruments.

Key Features: Each test kit includes specific components such as test cassettes, solutions, and controls, with storage conditions and shelf life detailed. Some tests are compatible with automated interpretation using the BSX Reader.

Diagnostic Kits Overview: The document provides detailed information on various diagnostic kits used for detecting different bacterial and viral infections through methods such as lateral flow tests and real-time PCR. The kits are designed for in vitro diagnosis and are used in clinical settings.

1. Lateral Flow Tests:

PYLORITOP® Ab BSS: Detects anti-Helicobacter pylori antibodies in blood, serum, or plasma. The kit includes 25 test cassettes and pipettes, with a storage life of 24 months at 2-30°C.
BIOSYNEX® S. pneumoniae: Detects capsule wall polysaccharides in urine or CSF. Includes 20 test cassettes and a positive control, with an 18-month storage life at 2-30°C.
BIOSYNEX® Legionella: Detects Legionella pneumophila serogroup 1 antigen in urine. Contains 25 test cassettes and a positive control, with an 18-month storage life at 2-30°C.
STREPTOP® A and STREPTATEST®: Detects Streptococcus group A antigens in throat swabs. Kits include test strips, extraction solutions, and controls, with a 24-month storage life at 2-30°C.
SYPHILITOP®: Detects anti-Treponema pallidum antibodies in blood, plasma, or serum. Includes 50 test cassettes and pipettes, with a 24-month storage life at 2-30°C.

2. Molecular Biology (PCR) Kits:

Chlamydia trachomatis PCR Kit: Detects Chlamydia trachomatis by real-time PCR. Includes Master Mix tubes and controls, with a 12-month storage life at -20°C.
RealLine N. gonorrhoeae (lyo): Lyophilized kit for detecting Neisseria gonorrhoeae DNA. Includes Ready Master Mix tubes and controls, with a 12-month storage life at 4-8°C.
RealLine Multiplex Kits: Various kits for detecting multiple pathogens such as Mycoplasma, Gardnerella, and Treponema pallidum. Each kit includes Ready Master Mix tubes and controls, with a 12-month storage life at 4-8°C.

3. Agglutination Tests:

Staph aureus Fumouze®: Coagglutination slide test for identifying Staphylococcus aureus. Includes test red blood cells and droppers, with a 16-month storage life at 2-8°C.
RPR Card Test: Detects reaginic antibodies in serum or plasma. Available in 100 and 500 test formats, with a 24-month storage life at 2-8°C.
Streptozyme Fumouze®: Slide haemagglutination test for detecting antistreptococcic antibodies. Includes test blood cells and a dropper, with a 50-test capacity.

Storage and Handling: Most kits require storage at temperatures ranging from 2-30°C, with specific kits needing refrigeration at 2-8°C or freezing at -20°C. Each kit includes specific components necessary for conducting the tests, such as test cassettes, pipettes, and control solutions.

Agglutination Tests:

Candidiasis Identification: Two kits are available for the identification of Candida albicans and Candida dubliniensis using latex agglutination. The kits contain latex reagents, dissociating reagents, test cards, stirrers, and droppers. They are stored at 2-8°C for 15 months.
Aspergillosis Serology: This kit uses indirect haemagglutination for aspergillosis diagnosis. It includes sensitized and non-sensitized red blood cells, buffer solution, adsorbent, and controls, with a storage life of 18 months at 2-8°C.
Candidiasis Serology: Similar to the aspergillosis kit, it uses indirect haemagglutination for candidiasis diagnosis and has a storage life of 16 months at 2-8°C.

Staining Reagents:

MycetColor: Used for staining fungal elements for microscopic examination. It includes dissociating and staining reagents, black cards, and sticks, with a storage life of 18 months at 12-25°C.
MycetBlue: For staining fungal elements post-culture, with a storage life of 18 months at 12-25°C.
MycetFluo: Provides fluorescent staining for direct microscopic examination, with a storage life of 18 months at 12-25°C.

Molecular Biology (PCR):

Candida albicans Detection: Real-time PCR kits for detecting Candida albicans and Gardnerella vaginalis DNA in clinical samples. Each kit includes master mix tubes, positive control, and internal control, with a storage life of 12 months at 4-8°C.

Rapid Diagnostic Tests (RDT) - Lateral Flow:

Epstein-Barr Virus: Kits for detecting IgG and IgM antibodies in blood, serum, or plasma, with a storage life of 12 months at 2-30°C.
Dengue: Kits for detecting NS1 antigen and IgG/IgM antibodies in blood, serum, or plasma, with a storage life of 24 months at 2-30°C.
Respiratory Infections: Kits for detecting influenza and RSV antigens from swabs, with a storage life of 12-18 months at 2-30°C.
Gastrointestinal Infections: Kits for detecting norovirus, rotavirus, and adenovirus in stool samples, with a storage life of 12-24 months at 2-30°C.
Hepatitis: Kits for detecting hepatitis A, B, C, and E antibodies and antigens in serum and plasma, with a storage life of 18-24 months at 2-30°C.
HIV: Kits for detecting HIV-1 and HIV-2 antibodies in serum, plasma, and whole blood, with a storage life of 24 months at 2-30°C.

Molecular Biology (PCR) for HIV, HCV, HBV:

HIV Real-TM Quant: Quantitative detection of HIV-1 RNA in plasma, with a storage life of 12 months at 2-8°C.
HCV Real-TM Quant: Quantitative detection of HCV RNA in plasma, with a storage life of 12 months at 2-8°C.
HBV Real-TM Quant: Quantitative detection of HBV DNA in plasma, with a storage life of 12 months at 2-8°C.
Comprehensive Detection: Kits for simultaneous detection of HIV, HCV, and HBV in plasma, with a storage life of 12 months at 2-8°C and -20°C.

Overview: This document provides detailed information on various diagnostic kits used for the detection of viral and bacterial infections, as well as other health conditions. The kits are primarily based on PCR (Polymerase Chain Reaction) technology and lateral flow assays, designed for in vitro diagnostics.

1. HIV, HCV, HBV Detection:

These kits are designed to detect HIV1 RNA, HIV2 RNA, HCV RNA, and HBV DNA in plasma samples. They can be used for individual samples or pooled samples with a recommended pool size of 5-10 samples.
Kit contents include internal controls, positive and negative controls, PCR mixes, and enzymes necessary for the detection process.
Storage conditions are specified as 12 months at 2-8°C and -20°C.

2. Herpes Simplex Virus (HSV) Detection:

Kits are available for the qualitative detection and differentiation of HSV type I and II DNA in various biological samples.
Kit contents include PCR mixes, polymerase, and control samples.
Storage is recommended at -16°C for 12 months.

3. Human Papillomavirus (HPV) Detection:

Kits are designed for the detection of 14 genotypes of HPV, including types 16, 18, and 45, with clinical significance.
Includes internal controls to ensure the presence of cellular material in samples.
Storage conditions are 12 months at -20°C.

4. Cytomegalovirus (CMV) Detection:

Available in both lyophilized and liquid formats for the detection of CMV DNA in clinical samples.
Kit contents include master mixes, calibrators, and internal standards.
Storage varies between 4-8°C and -20°C depending on the kit format.

5. Epstein-Barr Virus (EBV) Detection:

Kits for the detection of EBV DNA are available in lyophilized and liquid formats.
Includes positive control samples and ready master mix tubes.
Storage conditions are 12 months at 4-8°C and -20°C.

6. Varicella Zoster Virus (VZV) Detection:

Lyophilized kits for the detection of VZV in clinical samples.
Kit contents include positive control samples and master mix tubes.
Storage is recommended at 4-8°C for 12 months.

7. Human Herpesvirus 6 (HHV-6) Detection:

Kits for the detection of HHV-6 DNA in clinical samples.
Includes positive control samples and master mix tubes.
Storage conditions are 12 months at 4-8°C.

8. Rubella, TBEV, and Ebola Virus Detection:

Lyophilized kits for the detection of Rubella RNA, TBEV RNA, and Ebola virus RNA.
Kit contents include positive control samples and master mix tubes.
Storage is recommended at 4-8°C for 12 months.

9. Drug Detection and Urinary Strips:

DrugCheck+ kits for the detection of various drugs and metabolites in urine and saliva.
Urinary strips for the detection of multiple parameters in urine, compatible with specific readers.
Storage conditions vary between 12 to 18 months at 2-30°C.

10. Cancer and Health Markers:

Kits for the detection of colorectal cancer, bladder tumor antigen, CRP, PSA, micro-albumin, and cardiac markers.
Each kit includes specific test cassettes, pipettes, and diluents.
Storage conditions vary between 12 to 24 months at 2-30°C.

11. Women's Health:

Rapid tests for obstetrics, including detection of IGFBP-1 for premature rupture of fetal membranes.
Kit contents include test strips, swabs, and diluents.
Storage is recommended at 18 months at 2-30°C.

Catalog excerpts

NORTH AREA (North America, Europe, North Asia) Tel.: (+33) 3 88 78 78 87 E-mail: [email protected] Dr. Ihab KAZMA SOUTH AREA (Central and South America, Middle East, South East Asia, Oceania) Tel.: (+33) 3 88 77 57 22 E-mail: [email protected] Mr. Said EL CHIBANI AFRICAN AREA Tel.: (+33) 3 88 77 57 28 E-mail: [email protected] Dr. Marwan BOUANANI VISIT OUR WEBSITE www.biosynex.com/en

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BIOSYNEX, THE FRENCH LEADER IN RAPID DIAGNOSTIC TESTS (RDT) OUR TASKS To design, develop and offer innovative solutions devoted to health. To guarantee a favoured commercial relationship for each partner. To remain attentive to our customers' needs and market trends. OUR DNA A strong entrepreneurial culture, and one of innovation and quality on which our expertise is based A committed, trained team of men and women with a mutual objective: customer satisfaction. Anticipating tomorrow's needs is proof of masteret expertise. OUR IDENTITY Biosynex is the partner for healthcare specialists: "For...

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Contents BACTERIOLOGY RDT - LATERAL FLOW Chlamydia trachomatis . . . . . . . . . . . . . . . . . . . . . . . . 9 Clostridium difficile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Clostridium tetani. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Helicobacter pylori. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Legionella pneumophila . . . . . . . . . . . . . . . . . . . . . 12 Streptococcus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Treponema pallidum. . . . . . . . . . . . . . . . . . . . . . . . . . 14 MOLECULAR BIOLOGY (PCR)...

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BIOCHEMISTRY ONCOLOGY RDT - LATERAL FLOW Toxicology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Urinary strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Colorectal cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bladder tumor antigen . . . . . . . . . . . . . . . . . . . . . . . C reactiv protein CRP . . . . . . . . . . . . . . . . . . . . . . . . . Prostate cancer PSA . . . . . . . . . . . . . . . . . . . . . . . . . . Cardiac makers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hemostasis. . . ....

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Summary BORDETELLA PERTUSSIS PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 CHLAMYDIA PNEUMONIAE PCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 CHLAMYDIA TRACHOMATIS RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 PCR. . . . . . . . . . . . . . . . . . . . . 15, 17, 18, 19 CLOSTRIDIUM DIFFICILE RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9,10 CLOSTRIDIUM TETANI RDT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 HELICOBACTER PYLORI RDT. ....

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LATERAL FLOW BACTERIOLOGY CHLAMYDIA TRACHOMATIS Kit content: • 20 test cassettes • 1 bottle of solution A • 1 bottle of solution B • 20 extraction tubes • 20 Dacron swabs (CE) Storage: 12 months at 2-30°C C€ 1023 REF. 6120004 Positive and Negative controls C. difficile Tox A & B REF. 1030009 IMMUNOQUICK® TOX A & B Detection of toxin A & B from C. difficile bacteria in stool samples. Kit content: • 20 test cassettes • 1 vial of sample diluent buffer Storage: 12 months at 2-30°C C€ For 10 positive controls and 10 negative controls with IMMUNOQUICK® TOX A&B (ref. 1030009) Storage: 12 months at 2-8°C...

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RDT - LATERAL FLOW REF. 1030008 IMMUNOQUICK® C.DIFFICILE GDH Detection of glutamate dehydrogenase from C.difficile in stool samples 25 tests Kit content: • 25 test cassettes • 25 vials of sample dilution buffer • 1 positive control with recombinant GDH • Barcode for test batch identification Storage: 18 months at 2-30°C C€ REF. 1030016 TETANOTOP® Detection of tetanus antitoxin antibodies in serum, plasma or whole blood. REF. 502880 Positive control Tetanus 1 x 0.5 mL Kit content: • 20 test cassettes • 20 pipettes • 1 vial of buffer • Barcode card for test batch identification Storage: 18 months...

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Detection of anti-Helicobacter pylori antigens in human stool samples. 25 tests Kit content: • 25 test cassettes • 25 vials of diluent IgG Positive control Helicobacter 1 vial of 200 µL For 2 controls with PYLORITOP® Ab (ref. 1030010) Storage: 12 months at 2-8°C IgA Positive control Helicobacter 1 vial of 200 µL For 2 controls with PYLORITOP® Ab (ref. 1030010) Storage: 12 months at 2-8°C PYLORITOP® Ag with accessories Detection of anti-Helicobacter pylori antigens in human stool samples. 20 tests with stool collection papers Kit content: • 20 test cassettes • 20 vials of diluent • 20 stool collection...

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REF. 1030001 BIOSYNEX® Legionella Detection of Legionella pneumophila serogroup 1 antigen in the urine. Kit content: • 25 test cassettes • 25 pipettes • Positive control Storage: 18 months at 2-30°C C€ REF. 1030002 BIOSYNEX® S. pneumoniae Detection of capsule wall polysaccarides CWPS in the urine or CSF. Kit content: • 20 test cassettes • 20 pipettes • 1 vial of buffer • Positive control • Barcode for test batch identification Storage: 18 months at 2-30°C C€

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STREPTATEST® Detection of Streptococcus group A antigens in throat swabs. 25 tests with contols and accessories Kit content: • 25 strips • Extraction solution 1 • Extraction solution 2 • 25 extraction tubes • 25 sterile swabs (CE 0086) • 25 tongue depressors • Rack • Positive control • Negative control Storage: 24 months at 2-30°C C€ 20 tests with controls Kit content: • 20 test cassettes • Extraction solution 1 • Extraction solution 2 • 20 extraction tubes • 20 sterile swabs (CE 0086) • Rack • Positive control • Negative control Storage: 24 months at 2-30°C C€ STREPTOP® A Detection of Streptococcus...

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INTERNATIONAL CATALOGUE 2019

INTERNATIONAL CATALOGUE 2019

Catalog excerpts

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