Devices and methods for detecting amniotic fluid in vaginal secretions
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-033/558
G01N-033/68
출원번호
US-0970342
(2013-08-19)
등록번호
US-9494596
(2016-11-15)
발명자
/ 주소
Fuks, Boris
Petrunin, Dmitrii D.
Zaraisky, Evgeny I.
Boltovskaya, Marina N.
Nazimova, Svetlana V.
Starosvetskaya, Nelly A.
Konstantinov, Alexandr
Marshiskaia, Margarita I.
출원인 / 주소
N-Dia, Inc.
대리인 / 주소
Fish & Richardson P.C.
인용정보
피인용 횟수 :
0인용 특허 :
51
초록
The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.
대표청구항▼
1. A method for diagnosing rupture of fetal membranes (ROM) with 100% negative predictive value in a pregnant woman using a device comprising a pad region and a test region, the method comprising: (a) introducing a vaginal fluid sample obtained from the pregnant woman to the pad region of the device
1. A method for diagnosing rupture of fetal membranes (ROM) with 100% negative predictive value in a pregnant woman using a device comprising a pad region and a test region, the method comprising: (a) introducing a vaginal fluid sample obtained from the pregnant woman to the pad region of the device, wherein the pad region comprises a first monoclonal antibody that is specific for PAMG-1 protein, wherein the first monoclonal antibody is mobilizable and binds to the PAMG-1 protein when present in the sample to form a PAMG-1 protein/monoclonal antibody complex;(b) detecting, in the test region of the device, the presence of the PAMG-1 protein/monoclonal antibody complex in the sample, only when the concentration of the PAMG-1 protein in the sample exceeds a predefined detection threshold, wherein the test region comprises a second monoclonal antibody that is specific for the same PAMG-1 protein and is immobilized in the test region, wherein:(i) the first and second monoclonal antibodies do not cross-react with each other and wherein the first and second PAMG-1-specific monoclonal antibodies are selected from the group consisting of M271, produced by hybridoma N271, deposited with the Russian National Collection of Industrial Microorganisms (VKPM) Depository and assigned accession number VKPM-93; M52, produced by hybridoma N52, deposited with the VKPM and assigned accession number VKPM-92; and M42, produced by hybridoma N42, deposited with the VKPM and assigned accession number VKPM-94; and(ii) the predefined detection threshold is set at 5 ng/ml, a level that eliminates 100% of false positive results by adjusting the concentration of one or both of the first and second monoclonal antibodies; and(c) diagnosing ROM with 100% negative predictive value if the PAMG-1 protein is detected in the sample. 2. The method of claim 1, further comprising diagnosing ROM with at least 99% specificity and 100% sensitivity. 3. The method of claim 1, further comprising diagnosing ROM with 99% positive predictive value. 4. The method of claim 1, wherein the pregnant woman is at 20 to 41 weeks' gestation. 5. A method for diagnosing ROM with at least 99% positive predictive value in a pregnant woman using a device comprising a pad region and a test region, the method comprising: (a) introducing a vaginal fluid sample obtained from the pregnant woman to the pad region of the device, wherein the pad region comprises a first monoclonal antibody that is specific for PAMG-1 protein, wherein the first monoclonal antibody is mobilizable and binds to the PAMG-1 protein when present in the sample to form a PAMG-1 protein/monoclonal antibody complex;(b) detecting, in the test region of the device, the presence of the PAMG-1 protein/monoclonal antibody complex in the sample, only when the concentration of PAMG-1 in the sample exceeds a predefined detection threshold that is set at a level that reduces false negative results such that at least 99% positive predictive value is achieved, wherein the test region comprises a second monoclonal antibody that is specific for the same PAMG-1 protein and is immobilized in the test region, wherein:(i) the first and second monoclonal antibodies do not cross-react with each other and wherein the first and second PAMG-1-specific monoclonal antibodies are selected from the group consisting of M271, produced by hybridoma N271, deposited with the Russian National Collection of Industrial Microorganisms (VKPM) Depository and assigned accession number VKPM-93; M52, produced by hybridoma N52, deposited with the VKPM and assigned accession number VKPM-92; and M42, produced by hybridoma N42, deposited with the VKPM and assigned accession number VKPM-94; and(ii) the predefined detection threshold is set at 5 ng/ml by adjusting the concentration of one or both of the first and second monoclonal antibodies; and(c) diagnosing ROM with at least 99% positive predictive value if the PAMG-1 protein is detected in the sample. 6. The method of claim 5, further comprising diagnosing ROM with at least 99% specificity and 100% sensitivity. 7. The method of claim 5, wherein the pregnant woman is at 20 to 41 weeks' gestation. 8. A method for diagnosing ROM in a pregnant woman with at least 99% specificity and 100% sensitivity using a device comprising a pad region and a test region, the method comprising: (a) introducing a vaginal fluid sample obtained from the pregnant woman to the pad region of the device, wherein the pad region comprises a first monoclonal antibody that is specific for PAMG-1 protein, wherein the first monoclonal antibody is mobilizable and binds to the PAMG-1 protein when present in the sample to form a PAMG-1 protein/monoclonal antibody complex;(b) detecting, in the test region of the device, the presence of the PAMG-1 amniotic protein/monoclonal antibody complex in the sample, only when the concentration of the PAMG-1 protein in the sample exceeds a predefined detection threshold, wherein the test region comprises a second monoclonal antibody that is specific for the same PAMG-1 protein and is immobilized in the test region of the device, wherein:(i) the first and second monoclonal antibodies do not cross-react with each other and wherein the first and second PAMG-1-specific monoclonal antibodies are selected from the group consisting of M271, produced by hybridoma N271, deposited with the Russian National Collection of Industrial Microorganisms (VKPM) Depository and assigned accession number VKPM-93; M52, produced by hybridoma N52, deposited with the VKPM and assigned accession number VKPM-92; and M42, produced by hybridoma N42, deposited with the VKPM and assigned accession number VKPM-94; and(ii) the predefined detection threshold is set at 5 ng/ml by adjusting the concentration of one or both of the first and second monoclonal antibodies; and(c) diagnosing ROM with at least 99% specificity and 100% sensitivity if the PAMG-1 protein is detected in the sample. 9. A method for diagnosing ROM with 100% negative predictive value in a pregnant woman using a device comprising a pad region and a test region, the method comprising: (a) introducing a vaginal fluid sample obtained from the pregnant woman to the pad region of the device, wherein the pad region comprises a first monoclonal antibody that is mobilizable and is specific for PAMG-1 protein;(b) detecting, in the test region of the device, the presence of the PAMG-1 protein only when the concentration of the PAMG-1 protein in the sample exceeds a predefined detection threshold, wherein the test region comprises a second monoclonal antibody that is specific for the same PAMG-1 protein and is immobilized in the test region; wherein:(i) the first and second monoclonal antibodies do not cross-react with each other and wherein the first and second PAMG-1-specific monoclonal antibodies are selected from the group consisting of M271, produced by hybridoma N271, deposited with the Russian National Collection of Industrial Microorganisms (VKPM) Depository and assigned accession number VKPM-93; M52, produced by hybridoma N52, deposited with the VKPM and assigned accession number VKPM-92; and M42, produced by hybridoma N42, deposited with the VKPM and assigned accession number VKPM-94; and(ii) the predefined detection threshold is set at 5 ng/ml, a level that eliminates 100% of false positive results by adjusting the concentration of one or both of the first and second monoclonal antibodies; and(c) diagnosing ROM with 100% negative predictive value if the PAMG-1 protein is detected in the sample.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (51)
Yang Hsin M. (San Diego CA) Newton Michael (San Diego CA) Liu Ping (La Jolla CA), Analyte detection device including a hydrophobic barrier for improved fluid flow.
Berger Johann (Indianapolis IN) DeLaCroix Fern (Indianapolis IN) Buck Harvey (Indianapolis IN) Schrenk Juergen (Indianapolis IN), Apparatus for determination of a component in a sample.
Gribnau Thomas C. J. (Haren NLX) Roeles Frits (Dreumel NLX) Leuvering Johannes H. W. (Heesch NLX), Application of water-dispersible hydrophobic dyes or pigments as labels in immunoassays.
May Keith (Bedfordshire GB2) Prior Michael E. (Northamptonshire GB2) Richards Ian (Bedford GB2), Capillary immunoassay and device therefor comprising mobilizable particulate labelled reagents.
Cowley David M. (Brisbane AUX) Maguire David J. (Brisbane AUX) Voroteliak Victor (Brisbane AUX), Diamine oxidase and assay for rupture of amniotic membrane in pregnant mammals.
M. Javad Khosravi CA; Jehangir Mistry ; Anastasia Diamandi CA, Immunoassay of IGF family of peptides, their binding proteins and related molecules in dried whole blood filter paper spots.
Tarcha Peter J. (Lake Villa IL) Donovan James J. (Waukegan IL) Wong Martin (Grayslake IL), Indicator reagents, diagnostic assays and test kits employing organic polymer latex particles.
Eisinger Robert W. (San Diego CA) Khalil Mohammed H. (San Diego CA) Katz David H. (La Jolla CA) Sargeant Robert B. (Ramona CA), Lateral flow, non-bibulous membrane assay protocols.
Konstantinov Alexander (Princeton NJ) Foux Boris (Moscow RUX) Stepanov Alexander (Moscow RUX) Zaraisky Evgeny (Moscow RUX) Nazimova Svetlana (Moscow RUX) Boltovskaya Marina (Moscow RUX) Starosvetskay, Method for detecting free insulin-like growth-factor-binding protein 1 and a test device for detecting the ruptures of f.
Sanders Brenda M. ; Jenkins Kenneth D. ; Nichols Jack L.,CAX ; Imber Bryan E.,CAX, Method of screening physiological samples for elevated levels of heat shock proteins.
Shanks Ian A. (Bedford GB2) Smith Alan M. (Bedford GB2), Photometric instruments, their use in methods of optical analysis, and ancillary devices therefor.
Monbaliu Marcel J. (Mortsel BEX) Terrell David R. (Lint BEX) De Meutter Stefaan K. (Zandhoven BEX), Photosensitive recording material having an N-aryl carbazole p-type charge transport compound.
Litman David J. (Los Altos CA) Li Thomas M. (Milpitas CA) Buelteman Laura L. (San Jose CA) Wong Emmy T. (Los Alto Hills CA), Qualitative immunochromatographic method and device.
Litman David J. (Los Altos CA) Li Thomas M. (Milpitas CA) Buelteman Laura L. (San Jose CA) Wong Emmy T. (Los Altos Hills CA), Qualitative immunochromatographic method and device.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.