Devices and methods for detecting amniotic fluid in vaginal secretions
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-033/53
G01N-033/68
G01N-033/558
출원번호
US-0675613
(2012-11-13)
등록번호
US-9568479
(2017-02-14)
발명자
/ 주소
Fuks, Boris
Petrunin, Dmitrii Dmitrievich
Zaraisky, Evgeny Il'ich
Boltovskaya, Marina Nikolayevna
Nazimova, Svetlana Vladimirovna
Starosvetskaya, Nelly Andronikovna
Konstantinov, Alexandr
Marshiskaia, Margarita Igorevna
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, the method comprising: (a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and
1. A method for diagnosing rupture of fetal membranes (ROM) with 100% negative predictive value in a pregnant woman, the method comprising: (a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for placental α1-microglobulin (PAMG-1), wherein at least one of the two monoclonal antibodies binds to the PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex, wherein said 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;(b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample, only when the concentration of the PAMG-1 in the sample exceeds a predefined detection threshold of 5 ng/ml, wherein the predefined detection threshold is set at a level that eliminates 100% of false positive results; and(c) diagnosing ROM with 100% negative predictive value if the PAMG-1 is detected in the sample. 2. The method of claim 1, wherein the predefined detection threshold is an amount greater than the regular background level of the PAMG-1 in vaginal secretions of pregnant women in the absence of ROM and less than the level of the PAMG-1 present in amniotic fluid. 3. The method of claim 1, further comprising diagnosing rupture of fetal membrane with at least 99% specificity and 100% sensitivity. 4. The method of claim 1, further comprising diagnosing rupture of fetal membrane with 99% positive predictive value. 5. The method of claim 1, wherein the pregnant woman is at 20 to 41 weeks gestation. 6. A method for diagnosing rupture of fetal membranes (ROM) with at least 99% positive predictive value in a pregnant woman, the method comprising: (a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for placental α1-microglobulin (PAMG-1), wherein at least one of the two monoclonal antibodies binds to the PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex, wherein said 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;(b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample, only when the concentration of the PAMG 1 in the sample exceeds a predefined detection threshold of 5 ng/ml that is set at a level that reduces false positive results such that at least 99% positive predictive value is achieved; and(c) diagnosing ROM with at least 99% positive predictive value if the PAMG-1 is detected in the sample. 7. The method of claim 6, wherein the predefined detection threshold is an amount greater than the regular background level of the PAMG-1 in vaginal secretions of pregnant women in the absence of ROM and less than the level of the PAMG 1 present in amniotic fluid. 8. The method of claim 6, further comprising diagnosing rupture of fetal membrane with at least 99% specificity and 100% sensitivity. 9. The method of claim 6, wherein the pregnant woman is at 20 to 41 weeks gestation. 10. A method for diagnosing rupture of fetal membranes (ROM) in a pregnant woman with at least 99% specificity and 100% sensitivity, the method comprising: a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for placental α1-microglobulin (PAMG-1), wherein at least one of the two monoclonal antibodies binds to the PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex, wherein said 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;(b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample, only when the concentration of the PAMG 1 in the sample exceeds a predefined detection threshold of 5 ng/ml; and(c) diagnosing ROM with at least 99% specificity and 100% sensitivity if the PAMG-1 is detected in the sample. 11. A method for diagnosing rupture of fetal membranes (ROM) with 100% negative predictive value in a pregnant woman, the method comprising: (a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for placental α1-microglobulin (PAMG-1), wherein said 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;(b) detecting the presence of the PAMG-1 only when the concentration of the PAMG 1 in the sample exceeds a predefined detection threshold of 5 ng/ml, wherein the predefined detection threshold is set at a level that eliminates 100% of false positive results; and(c) diagnosing ROM with 100% negative predictive value if the PAMG-1 is detected in the sample.
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