two know more than one! - · pdf filede droguri, maladii tropicale, virusologie,...
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Biosynex S.A. 12, rue Ettore Bugatti CS 28006 67038 Strasbourg Cedex FranceTel: +33 388 775700 Fax: + 33 359 812174
Email: [email protected] www.biosynex.com
Innovation, our Mission
Rapid
Convenient
Reliable
Efficient
Results in minutes
Can be used without speculum
Enhanced specificity
Two markers on one strip
AMNIOQUICK PLUS2 an advanced way to diagnose PROM!
New test to identify amniotic fluid in vaginal sample through the combined detection of two markers, IGFBP-1 and AFP.
IGFBP-1 line is calibrated at a high detection limit in order to obtain highly specific results even in near term women.
AFP line is calibrated at a very low detection limit so that it remains sensitive beyond a gestational age (G.A.) of 39 weeks.
Easy to use result interpretation card.
Test results:
Order now under reference numbers: 0538_K10, 0538_K25 or 0538_K50.
Patent pending
Two know more than one...!
IGFBP-1 positive IGFBP-1 negative
G.A. 39 weeks: Rupture G.A.
Innovation, our Mission
Rapid
Convenient
Reliable
Efficient
Results in 10 minutes
Can be used without speculum
Highly correlated to clinical status
Ideal for Point of Care testing
Virology Bacteriology Autoimmunity Parasitology Virology Bacteriology Autoimmunity Parasitology Virology Bacteriology Autoimmunity Parasitology
AMNIOQUICK Rupture of fetal membranes that occurs before the onset of labor is known as Premature Rupture of Membranes or PROM. PROM is relatively frequent and concerns 5 to 10 % of pregnancy cases. It might lead to preterm delivery and fetal infection. Appropriate management of PROM is important to reduce the conse-quences to neonatal health. The leakage of amniotic liquid is not always detectable by conventional clinical examination and therefore confirmatory biological test can be very useful. Biologi-cal tests are based on detection of alkalini-sation of vaginal fluid (easy to proceed, sensitive, inexpensive but poorly specific) or presence of a molecule which is physio-logically present in high concentration in amniotic fluid (diamine oxidase, alpha-fetoprotein, fibronectin, IGFBP-1).
AMNIOQUICK offers a convenient soluti-on to obstetricians and midwives for accu-rate diagnostic of PROM. AMNIOQUICK is a rapid test based on the detection in vaginal samples of IGFBP-1 (Insulin-Like Growth Factor Binding Protein-1) which is found in high concentration in amniotic fluid. AMNIOQUICK can be used from the early stages of pregnancy to near term women. It is an easy-to-use rapid test that allows better management of PROM.
Biosynex S.A.12, rue Ettore Bugatti CS 2800667308 Strasbourg Cedex FranceTel: +33 388 775700 Fax: + 33 359 812174Email: [email protected] www.biosynex.com
Biosynex Deutschland GmbHRobert-Bosch-Breite 23
37079 Goettingen GermanyTel: +49 551 504 11 0 Fax: +49 551 504 11 29
Email: [email protected] www.biosynex.de
AMNIOQUICK
Rupturile de membrana fetala care se produc inainte de aparitia travaliului sunt cunoscute sub denumirea de rupturi premature de membrana sau PROM (Premature Rupture Of Membranes). Rupturile premature de memebrana au o frecventa relativ crescuta astfel ca ele pot sa apara la aproximativ 5 pana la 10% dintre femeile insarcinate. PROM pot conduce la nastere prematura si la infectia fetala in consecinta managementul corect al PROM este important pentru a reduce consecintele asupra starii de sanatate a nou nascutilor. Pierderea lichidului amniotc nu este intotdeauna detectabila prin metodele conventionale clinice existenta unor teste biologice confirmatorii fiind foarte utila. Testele biologice au la baza detctia alcalinizarii fluiului vaginal (metoda simpla, sensibila, ieftina dar foarte putin specifica) sau identificarea unor molecule fiziologic prezente in concentratii mari in fluidul amniotic (diamin oxidaza, alfafetoproteina, fibronectina, IGFBP-1)AMNIOQUICK ofera o solutie convenabila pentru obstetricieni pentru a putea pune un diagnostic cat mai precis al PROM. AMNIOQUICK este un test rapid bazat pe detectia in probele vaginale a IGFBP-1 (insulin like growth factor binding protein-1) care se gaseste in concentratii mari in fluidul amniotic. AMNIOQUICK poate fi utilizat incepand inca din stadiile timpurii ale sarcinii si pana aproape de termen. Acest test este un test usor de utilizat, rapid care permite o diagnosticare foarte precisa a PROM corelata excelent cu statusul clinic.
Rezultat pozitiv apare o banda colorata in mov in zona de test (T) si in zona de control (C)
Rezultat negativ apare doar o banda in zona de control (C)
Rezultat invalid Nu apare nici o banda vizibila in zona control (C). Acest test este invalid si trebuie repetat folosind un strip nou
ISO 9001
ISO 13485
www.biosynex.comwww.biosynex.de
The BIOSYNEX Group is one of the most significant manufacturers of rapid membrane tests on the in-vitro diagnostic market. We offer high quality, easy to use Drugs of Abuse, Tropi-cal Disease, Virology, Bacteriology, Autoimmune Disease, Oncology, Cardiology, Fertility, Obstetrics and Emergency Medicine kits.
Interpretation
POSITIVE RESULT
A purple colored band appears in
the Test zone (T) and in the Control
Zone (C)
NEGATIVE RESULT
Only one band appears in the
control (C) zone.
INVALID RESULTS
No visible band in the control (C)
zone. The test is invalid and should
be repeated with a new strip.
Performance
Our Research and Development laboratories in Germany and France and our state of the art manufac-turing facilities are dedicated to continuously meet the needs of our customers.Our aim is to provide diagnostic tests to help physici-ans make faster and better medical and therefore lifesaving decisions.
CT
Additional Information
REF 0524_K10 : each kit contains 10 tests REF 0524_K25 : each kit contains 25 testsREF 0524_K50 : each kit contains 50 tests
Guaranteed shelf life: 18 monthsStorage conditions: 2-30C
AMNIOQUICK can detect less than 1 microliter of amniotic
fluid in vaginal secretions. The cut-off of the test for IGFBP-1
has been adjusted to detect 5ng/ml in order to limit the
interference other potentially contaminating fluids (semen,
urine or blood).
CT
CT
Biosynex S.A.12, rue Ettore Bugatti CS 2800667308 Strasbourg Cedex FranceTel: +33 388 775700 Fax: + 33 359 812174Email: [email protected] www.biosynex.com
Biosynex Deutschland GmbHRobert-Bosch-Breite 23
37079 Goettingen GermanyTel: +49 551 504 11 0 Fax: +49 551 504 11 29
Email: [email protected] www.biosynex.de
Interpretarea rezultatelor
Performantele testului
Coduri pentru comandaREF 0524_K10 : fiecare kit contine 10 testeREF 0524_K25 : fiecare kit contine 25 testeREF 0524_K50 : fiecare kit contine 50 teste
Termen de valabilitate: 18 luniConditii de stocare: 2-30 C
AMIOQUICK poate detecta mai putin de 1 microlitru de lichid amniotic in secretiile vaginale. Cutofful testului pentru IGFBP-1 a fost ajustat sa detecteze 5ng/mL pentru a limita interferenta cu alte fluide potential contaminate (sperma, sange sau urina)
Informatii aditionale
ISO 9001
ISO 13485
www.biosynex.comwww.biosynex.de
The BIOSYNEX Group is one of the most significant manufacturers of rapid membrane tests on the in-vitro diagnostic market. We offer high quality, easy to use Drugs of Abuse, Tropi-cal Disease, Virology, Bacteriology, Autoimmune Disease, Oncology, Cardiology, Fertility, Obstetrics and Emergency Medicine kits.
Interpretation
POSITIVE RESULT
A purple colored band appears in
the Test zone (T) and in the Control
Zone (C)
NEGATIVE RESULT
Only one band appears in the
control (C) zone.
INVALID RESULTS
No visible band in the control (C)
zone. The test is invalid and should
be repeated with a new strip.
Performance
Our Research and Development laboratories in Germany and France and our state of the art manufac-turing facilities are dedicated to continuously meet the needs of our customers.Our aim is to provide diagnostic tests to help physici-ans make faster and better medical and therefore lifesaving decisions.
CT
Additional Information
REF 0524_K10 : each kit contains 10 tests REF 0524_K25 : each kit contains 25 testsREF 0524_K50 : each kit contains 50 tests
Guaranteed shelf life: 18 monthsStorage conditions: 2-30C
AMNIOQUICK can detect less than 1 microliter of amniotic
fluid in vaginal secretions. The cut-off of the test for IGFBP-1
has been adjusted to detect 5ng/ml in order to limit the
interference other potentially contaminating fluids (semen,
urine or blood).
CT
CT
Biosynex S.A.12, rue Ettore Bugatti CS 2800667308 Strasbourg Cedex FranceTel: +33 388 775700 Fax: + 33 359 812174Email: [email protected] www.biosynex.com
Biosynex Deutschland GmbHRobert-Bosch-Breite 23
37079 Goettingen GermanyTel: +49 551 504 11 0 Fax: +49 551 504 11 29
Email: [email protected] www.biosynex.de
Biosynex Group este unul dintre cei mai importanti producatori de teste rapide pentru piata de diagnostic in vitro Biosynex Group ofera teste rapide pentru identificarea de droguri, maladii tropicale, virusologie, bacteriologie, maladii autoimune, oncologie, cardiologie, fertil