WO1995030150B1 - Method for detecting free igfbp-1 - Google Patents

Method for detecting free igfbp-1

Info

Publication number
WO1995030150B1
WO1995030150B1 PCT/IB1995/000364 IB9500364W WO9530150B1 WO 1995030150 B1 WO1995030150 B1 WO 1995030150B1 IB 9500364 W IB9500364 W IB 9500364W WO 9530150 B1 WO9530150 B1 WO 9530150B1
Authority
WO
WIPO (PCT)
Prior art keywords
igfbp
igf
free
monoclonal antibody
detecting
Prior art date
Application number
PCT/IB1995/000364
Other languages
French (fr)
Other versions
WO1995030150A1 (en
Filing date
Publication date
Priority claimed from US08/234,851 external-priority patent/US5597700A/en
Application filed filed Critical
Priority to AU24163/95A priority Critical patent/AU706284B2/en
Priority to EP95918108A priority patent/EP0755515B1/en
Priority to JP07528104A priority patent/JP2001501723A/en
Priority to DE69513160T priority patent/DE69513160D1/en
Publication of WO1995030150A1 publication Critical patent/WO1995030150A1/en
Publication of WO1995030150B1 publication Critical patent/WO1995030150B1/en

Links

Abstract

A method and device is described for detecting fetal membrane rupture by detecting only that insulin-like growth-factor-binding protein 1 (IGFBP-1) which is free of insulin-like growth factors 1 and 2 (IGF-1 and IGF-2). The method is based on the fact that the concentration of free IGFBP-1 in the blood serum is about ten times lower than that of the IGFBP-1 bound to IGF-1 and IGF-2, while the amniotic liquid which is contained in the amnion has more than 1000 times the concentration of free IGFBP-1 than the blood serum. The device comprises a one pad (22) and two strips (24, 26) test kit which may be used to detect free IGFBP-1 in a range of concentrations from 5 ng/ml to 250 νg/ml.

Claims

AMENDED CLAIMS[received by the International Bureau on 1 November 1995 (01.11.95); original claims 1-8, 17, 18, 20, 21 and 23-25 cancelled; new claim 4 added; remaining claims amended and renumbered as claims 1-3 and 5-12 (3 pages)]
1. A method for detecting free insulin-like growth-fac¬ tor-binding protein 1 (IGFBP-1) in a sample containing amniotic fluid, where the fluid contains IGFBP-1 free of insulin growth factor 1 (IGF-1) and insulin growth factor 2 (IGF-2) , said method comprising: contacting the sample with a first labeled monoclonal antibody which is reactive with free IGFBP-1, to form an IGFBP-1- labeled antibody complex in the presence of free IGFBP-1 in the sample, reacting such complex with a solid support having immobilized thereon, a second monoclonal antibody which is reactive with free IGFBP-1, where said first and second monoclonal antibodies (i) bind to first and second different binding sites on IGFBP-1, respectively, and (ii) each competes with IGF-1 and IGF-2 for binding to IGFBP-1; and detecting the presence of IGFBP-1 in the sample by detecting the IGFBP-1-labeled antibody complex bound to the solid support.
2. The method of claim 1, where the first monoclonal antibody is attached to a detectable agent selected from the group consisting of insoluble particles, enzymes, dyes, and radioactive isotopes.
3. The method of claim 1, where said detecting is effective for diagnosing fetal membrane rupture.
4. The method of claim 3, where said detecting is effective to determine low levels of free IGFBP-1 present in the amniotic fluid at concentrations down to about 10 ng/ml.
5. A device for detecting free insulin-like growth-fac¬ tor-binding protein 1 (IGFBP-1) in a sample containing amniotic fluid, where the fluid contains IGFBP-1 free of insulin growth factor 1 (IGF-1) and insulin growth factor 2 (IGF-2) , said device comprising: 2
a first porous medium containing a first monoclonal antibody, said antibody being labeled, and a second porous medium composed of a first element and a second element, said first and second elements being intercon¬ nected to the first medium, and where said first and second media allow migration of a liquid sample therethrough, said first element having a test region containing a second monoclonal antibody fixed therein, said second element having a control region composed of (i) a first part containing the second monoclonal antibody fixed therein and (ii) a second part containing free IGFBP-1 fixed therein, where said first and second monoclonal antibodies bind to first and second different binding sites on IGFBP-1, respec¬ tively, and each monoclonal antibody competes with IGF-1 and IGF-2 for binding to IGFBP-1.
6. The device of claim 5, for use in the diagnosis of fetal membrane rupture.
7. The device of claim 5, where said first labeled monoclonal antibody is freeze-dried.
8. The device of claim 5, which further includes a protective film covering at least a portion of said device.
9. The device of claim 5, wherein said second porous medium further contains the first monoclonal antibody in non-labeled form.
10. The device of claim 5, where the first medium is composed of a pad of glass fibers and the second medium is composed of nitrocellulose.
11. The device of claim 8, in which said film contains an aperture for sample introduction in the region covering said first porous medium.
12. The device of claim 11, further including a casing enclosing said device, where said casing possesses an opening above said aperture and observation windows located above said test region and said control region.
PCT/IB1995/000364 1994-04-28 1995-04-27 Method for detecting free igfbp-1 WO1995030150A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU24163/95A AU706284B2 (en) 1994-04-28 1995-04-27 Method and device for detecting free IGFBP-1
EP95918108A EP0755515B1 (en) 1994-04-28 1995-04-27 Method and device for detecting free igfbp-1
JP07528104A JP2001501723A (en) 1994-04-28 1995-04-27 Method and apparatus for detecting free IGFBP-1
DE69513160T DE69513160D1 (en) 1994-04-28 1995-04-27 METHOD AND TEST DEVICE FOR DETECTING FREE IGFBP-1

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/234,851 1994-04-28
US08/234,851 US5597700A (en) 1994-04-28 1994-04-28 Method for detecting free insulin-like growth-factor-binding protein 1 and a test device for detecting the ruptures of fetal membranes using the above method

Publications (2)

Publication Number Publication Date
WO1995030150A1 WO1995030150A1 (en) 1995-11-09
WO1995030150B1 true WO1995030150B1 (en) 1995-12-07

Family

ID=22883079

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB1995/000364 WO1995030150A1 (en) 1994-04-28 1995-04-27 Method for detecting free igfbp-1

Country Status (8)

Country Link
US (4) US5597700A (en)
EP (1) EP0755515B1 (en)
JP (1) JP2001501723A (en)
AT (1) ATE186403T1 (en)
AU (1) AU706284B2 (en)
CA (1) CA2189050A1 (en)
DE (1) DE69513160D1 (en)
WO (1) WO1995030150A1 (en)

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