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WO1988010272A1 - Procede de conservation d'un echantillon de fluide corporel, avant analyse de detection d'une infection par l'hiv (virus du sida) - Google Patents

Procede de conservation d'un echantillon de fluide corporel, avant analyse de detection d'une infection par l'hiv (virus du sida) Download PDF

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Publication number
WO1988010272A1
WO1988010272A1 PCT/AU1988/000221 AU8800221W WO8810272A1 WO 1988010272 A1 WO1988010272 A1 WO 1988010272A1 AU 8800221 W AU8800221 W AU 8800221W WO 8810272 A1 WO8810272 A1 WO 8810272A1
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sample
hiv
body fluid
patient
rna
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PCT/AU1988/000221
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English (en)
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Garth Alexander Nicholson
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G01N33/56988—HIV or HTLV

Definitions

  • the present invention relates to an improved method in the assay for the diagnosis of acquired immune deficiency syndrome or AIDS.
  • the method of this invention permits antibody, viral RNA and antigen tests to be performed on the same sample.
  • BACKGROUND ART Acquired immune deficiency syndrome has been described as the first great pandemic of the second half of the twentieth century (Gallo, R. C, Scientific American, 256, 1, January 1987 p39).
  • HIV Human Immunodeficiency Virus
  • the virus is known to be found in body fluids, particularly blood, saliva and semen.
  • the initial screening test for persons exposed or thought to be exposed to HIV consists of an in vitro qualitative enzyme immunoassay (ELISA) for antibodies to the HIV in human serum or plasma. This is a semi-automated procedure and is the major screening test in blood banks and hospitals. This test is sensitive but false positive reactions occur. There are three other testing procedures:
  • Immunofluorescent assay which is a non-automated procedure and thus is not well adapted to mass screening. It is used in confirmation of serum repeatedly positive to the ELISA screening test; Radioimmuno- precipitation assay; and Nestern immunoblot. The last two further tests which are more specific but less sensitive.
  • testing for antibodies to HIV is performed in selected teaching hospitals and laboratories and thus most blood samples for HIV testing-require transport. Blood to blood contact is the high risk route of infection and cases are now coming to light where laboratory workers handling HIV positive blood have been infected such as by inadvertent needle-stick injury or by breaking of tubes containing infected blood and splashing of the blood to broken skin or to the mouth and eye areas.
  • the present inventor has found that antibodies to HIV and HIV antigens and RNA can be stabilised during transport and handling whilst being in a relatively safe and manageable form by placing the sample of body fluid to be analysed on an absorbent substrate and drying the sample.
  • a particularly preferred absorbent substrate is filter paper.
  • the inventor has found that the HIV antibodies when eluated from the substrate retain their activity and the eluate can be assayed for antibodies to HIV to give reliable results.
  • the invention provides a method of detecting HIV infection in a patient, which method comprises taking a sample of body fluid from said patient, applying said sample to an absorbent substrate, drying said sample, optionally eluating sai-d dried sample from said substrate and testing the dried sample or eluate for the presence of one or more of antibodies to or indicative of HIV or HIV antigens or RNA.
  • the invention provides a method of stabilising antibodies to or indicative of HIV or HIV antigens or RNA in a body fluid, which method comprises applying a sample of said body fluid to an absorbent substrate and drying said sample on said substrate.
  • the invention provides a method of detecting HIV infection in a patient at an earlier stage than conventional antibody testing, in picking up patients in the "window” period, by the detection of HIV RNA, using the same stabilised and dried sample.
  • the absorbent substrate is filter paper or other absorbent cellulosic material such as nitrocellulose, or other absorbent material.
  • the filter paper is of a high quality such as Schleicher and Schull No. SS2992, although gel or beads or other absorbent could be used to immobilise the body fluid in a form which is less prone to spillage or splashing.
  • the body fluid may be blood or a fraction thereof, saliva or semen.
  • Immobilisation of the body fluid and antibodies to or indicative of HIV or HIV antigens or RNA therein on an absorbent substrate allows for treatment of the body fluid to reduce viral infectivity whilst maintaining activity of the antibodies to or indicative of HIV or HIV antigens or RNA insofar as their assay activity is concerned. This means that the body fluid can be more safely transported and handled.
  • Preferred treatments to reduce viral infectivity comprise heat treatment, treatment by UV light or other, e.g. gamma radiation, and treatment of the absorbent substrate with chemical additives that reduce viral infectivity.
  • Heat treatment at about 60o for about 10 minutes to 6 days is suitable.
  • the absorbent substrate may be impregnated with a chemical to reduce HIV infectivity can be provided to medical practitioners or pathology laboratories where samples are taken for AIDS testing.
  • heat treatment of blood products can be used to inactivate HIV. Therefore, in a preferred embodiment, the risk of contamination by the virus can be reduced by subsequent heat treatment of the body fluid on the absorbent substrate.
  • heat treatment consists of heating at about 60°C for about 10 mins to about 6 days. Data as shown hereafter shows that heat treated samples still give a positive result and thus the antibodies to HIV are still active whilst the virus infectivity is substantially reduced.
  • Quinnan et al in Transfusion, 26, 5, 1986, p481, describe methods for the inactivation of HIV. These methods include chemical treatment such as ethyl ether, ⁇ -propiolactone, formaldehyde or detergents, and such treatments are embraced by this form of the present invention.
  • a particularly preferred means of treatment to reduce viral activity is to impregnate the absorbent substrate with a suitable chemical which will reduce viral infectivity such as 4-aminomethyltrioxsalen before or after placing the body fluid sample thereon and contacting the body fluid sample with UV light, before, during or after contact of sample with said substrate.
  • Suitable immunological based assays include immuno-fluorescent assay, radioimmunoprecipitation assay, Western- immunoblot, and ELISA.
  • PCR polymerase chain reaction
  • the method of the invention permits anonymity by use of automated blood collection methods, coded paper sheets and automatic finger lancing or air jet machinery.
  • the coded sheet can be sent to a central laboratory and the patient can keep a receipt or tear-off portion of the coded paper sheet.
  • a sample of serum, whole blood or plasma is taken from the patient or is otherwise sampled. From the patient the sample may be removed using a syringe or by the "finger prick" method. The sample is then applied to the substrate, such as a filter paper strip.
  • the preferred filter paper is Schleicher and Schull No. SS2992. Other high quality filter paper is also a further example of a preferred substrate.
  • the sample is then air dried and a second application can then be applied if required.
  • the sample may be then stored for a limited duration of days or weeks. If desired, the sample is treated in accordance with the above, to reduce viral infectivity.
  • a portion or disc of filter paper impregnated with the body fluid is taken and the constituents of the body fluid are eluated from the substrate, such as with the assay diluent. Elution times may vary but times between 5 and 60 minutes are suitable preferably using a shaking apparatus. Small amounts of suitable detergent may be added to improve elution although this is not necessary.
  • the eluated sample is then used in a typical HIV immunoassay such as that marketed by Abbott Laboratories as ABBOTT HTLV-III EIA No. 1037, which is the test kit used in New South Wales hospitals and laboratories.
  • Each bead is then washed three times with 4-6 ⁇ l distilled water.
  • 200 ⁇ l of conjugate (anti-human IgG (goat): horseradish peroxidase) is placed in wells with the bead and incubated at 40°C for 2 hours ⁇ 10 minutes.
  • Each bead is washed with 4-6ml of distilled water three times.
  • Beads are then transferred to assay tubes and 300 ⁇ l of freshly prepared substrate consisting of o-phenylenediamine.2HCl (12.8mg/5ml) is then dispensed into assay tubes and incubated at room temperature for 30 ⁇ 2 minutes. The reaction is stopped with 1ml of IN sulfuric acid.
  • the methodology of the invention is applicable to sera or other body fluids which are also infected by viral hepatitis.
  • Viral hepatitis antibodies are quite commonly found in AIDS infected blood or blood thought to be AIDS infected. This virus also poses the significant risk to people handling the blood or other body fluid and in this further form of the invention there is provided a means of detecting viral hepatitis in a blood sample wherein a dried sample of a body fluid is eluated from an absorbent substrate and the eluate is tested for the presence of antibodies to or indicative of viral hepatitis.
  • the practice of the invention is also applicable to viral hepatitis.
  • EXAMPLE 1 Two different samples of HIV antibody positive blood were placed on Schleicher and Schull No. SS2992 paper and air dried and left for 48 hours.
  • PAPER WITHOUT SERUM 0.017 The above shows that sufficient HIV antibodies are stable on the filter paper for at least 24 hours so as to be detected in comparison to reference sera.
  • EXAMPLE 2 Two different samples of the same antibody positive blood and 3 reference sera as used in Example 1 were separately applied to Schleicher and Schull No. SS2992 filter paper in two applications and heat treated in an oven at 60°C for 24 hours. Two sets of 3 x 6.5mm discs were excised from each sample sheet and run through the ABBOTT assay. The results are as follows:
  • EXAMPLE 3 Two 10 ⁇ l samples of antibody (-ve) and antibody (+ve) serum were added to filter paper. It was noted that the sera spread to different sized circles so multiple aliquots were prepared. The paper was then dried at room temperature for 24-48 hours.
  • Test A two spots containing the full 10 ⁇ l serum spot dried on paper were used.
  • Test B four 6.5mm spots punched out from the centre of 10mm serum spots dried on paper were used.
  • Test B dried serum spots:

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Virology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • Physics & Mathematics (AREA)
  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Un procédé permettant de détecter une infection par l'HIV chez un patient consiste à prélever un échantillon de fluide corporel chez celui-ci et à le sécher sur un substrat absorbant. L'échantillon peut ensuite être éventuellement élué et l'éluat ou l'échantillon séché peuvent être testés pour déterminer la présence d'anticorps contre l'HIV ou contre des antigènes de l'HIV ou des ARN, au moyen d'analyses standard. Le procédé de la présente invention permet de garder l'anonymat grâce à l'utilisation de procédés de prélévement du sang automatisés et de substrats absorbants codés, le patient conservant un reçu codé ou une partie détachée du substrat, reçu ou partie grâce auquels il peut obtenir les résultats du test. Le procédé de la présente invention permet d'effectuer des tests d'anticorps, d'antigènes et d'ARN sur le même échantillon, ce qui permet d'effectuer un certain nombre de tests différents sur un seul échantillon stabilisé, séché et inactivé.
PCT/AU1988/000221 1987-06-26 1988-06-27 Procede de conservation d'un echantillon de fluide corporel, avant analyse de detection d'une infection par l'hiv (virus du sida) Ceased WO1988010272A1 (fr)

Applications Claiming Priority (2)

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AU271487 1987-06-26
AUPI2714 1987-06-26

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WO1988010272A1 true WO1988010272A1 (fr) 1988-12-29

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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995033996A1 (fr) * 1994-06-07 1995-12-14 Selfcare, Inc. Trousse et procede d'analyse a domicile avec verification telephonique des resultats
EP0717283A3 (fr) * 1994-12-13 1997-05-28 Ortho Pharma Corp Dispositif et trousse d'essai pour la détection du SIDA
US5695930A (en) * 1994-11-10 1997-12-09 Weinstein; David E. HIV test kit method for detecting anti-HIV-I antibodies in saliva
WO1998038512A1 (fr) * 1997-02-26 1998-09-03 M. Peterson & Søn As Recueil, stabilisation et stockage eventuel d'echantillons de fluides organiques, de feces et de secretions, aux fins d'analyses d'anticorps
US5978466A (en) * 1993-11-02 1999-11-02 Home Access Health Corporation Method and system for anonymously testing for a human malady
EP1032265A4 (fr) * 1997-11-20 2001-05-30 Cerus Corp Composes de psoralene utilises pour inactiver des agents pathogenes
US6469052B2 (en) 1993-06-28 2002-10-22 Cerus Corporation Compounds for the photodecontamination of pathogens in blood
US6503699B1 (en) 1993-06-28 2003-01-07 Cerus Corporation Method for photodecontamination of pathogens in blood using 5'-primary aminopsoralens
US6686480B2 (en) 1993-06-28 2004-02-03 Cerus Corporation Compounds for the photodecontamination of pathogens in blood
EP3375892A1 (fr) 2013-12-12 2018-09-19 Altratech Limited Capteur capacitif
US10995331B2 (en) 2013-12-12 2021-05-04 Altratech Limited Sample preparation method and apparatus
JP7066093B2 (ja) 2015-03-31 2022-05-13 グローバル・ライフ・サイエンシズ・ソリューションズ・オペレーションズ・ユーケー・リミテッド 生体試料コレクタおよびその取扱いの改良ならびにそれに関する改良
US11459601B2 (en) 2017-09-20 2022-10-04 Altratech Limited Diagnostic device and system

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU1717483A (en) * 1982-07-21 1984-01-26 Garth Nicholson Pty. Ltd. Substrate-stabilised sample and assay for myasthenia gravis
AU3227684A (en) * 1983-08-25 1985-02-28 Biotech Research Laboratories Detection of antibodies in human serum
JPS60142259A (ja) * 1983-12-29 1985-07-27 Kanebo Ltd 固定化抗体
WO1987003374A1 (fr) * 1985-11-26 1987-06-04 Murex Medical Research Limited Detection d'anticorps

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU1717483A (en) * 1982-07-21 1984-01-26 Garth Nicholson Pty. Ltd. Substrate-stabilised sample and assay for myasthenia gravis
AU3227684A (en) * 1983-08-25 1985-02-28 Biotech Research Laboratories Detection of antibodies in human serum
JPS60142259A (ja) * 1983-12-29 1985-07-27 Kanebo Ltd 固定化抗体
WO1987003374A1 (fr) * 1985-11-26 1987-06-04 Murex Medical Research Limited Detection d'anticorps

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PATENT ABSTRACTS OF JAPAN, P-411, page 67; & JP,A,60 142 259 (KANEBO K.K.), 27 July 1985 (27.07.85). *

Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6469052B2 (en) 1993-06-28 2002-10-22 Cerus Corporation Compounds for the photodecontamination of pathogens in blood
US6686480B2 (en) 1993-06-28 2004-02-03 Cerus Corporation Compounds for the photodecontamination of pathogens in blood
US6503699B1 (en) 1993-06-28 2003-01-07 Cerus Corporation Method for photodecontamination of pathogens in blood using 5'-primary aminopsoralens
US6014438A (en) * 1993-11-02 2000-01-11 Home Access Health Corporation Method and system for anonymously testing for a human malady
US6016345A (en) * 1993-11-02 2000-01-18 Home Access Health Corporation Method and system for anonymously testing for a human malady
US5978466A (en) * 1993-11-02 1999-11-02 Home Access Health Corporation Method and system for anonymously testing for a human malady
WO1995033996A1 (fr) * 1994-06-07 1995-12-14 Selfcare, Inc. Trousse et procede d'analyse a domicile avec verification telephonique des resultats
US6319665B1 (en) 1994-06-07 2001-11-20 Inverness Medical Technology, Inc. Home test kit and method with telephone verification of results
US5695930A (en) * 1994-11-10 1997-12-09 Weinstein; David E. HIV test kit method for detecting anti-HIV-I antibodies in saliva
EP0717283A3 (fr) * 1994-12-13 1997-05-28 Ortho Pharma Corp Dispositif et trousse d'essai pour la détection du SIDA
WO1998038512A1 (fr) * 1997-02-26 1998-09-03 M. Peterson & Søn As Recueil, stabilisation et stockage eventuel d'echantillons de fluides organiques, de feces et de secretions, aux fins d'analyses d'anticorps
US6455286B1 (en) 1997-11-20 2002-09-24 Cerus Corporation Psoralens for pathogen inactivation
EP1032265A4 (fr) * 1997-11-20 2001-05-30 Cerus Corp Composes de psoralene utilises pour inactiver des agents pathogenes
US11274291B2 (en) 2013-12-12 2022-03-15 Altratech Limited Sample preparation method and apparatus
US10746683B2 (en) 2013-12-12 2020-08-18 Altratech Limited Capacitive sensor and method of use
US10995331B2 (en) 2013-12-12 2021-05-04 Altratech Limited Sample preparation method and apparatus
EP3375892A1 (fr) 2013-12-12 2018-09-19 Altratech Limited Capteur capacitif
US11796498B2 (en) 2013-12-12 2023-10-24 Altratech Limited Capacitive sensor and method of use
US12487238B2 (en) 2013-12-12 2025-12-02 Altratech Limited Capacitive sensor and method of use
JP7066093B2 (ja) 2015-03-31 2022-05-13 グローバル・ライフ・サイエンシズ・ソリューションズ・オペレーションズ・ユーケー・リミテッド 生体試料コレクタおよびその取扱いの改良ならびにそれに関する改良
EP3277426B1 (fr) * 2015-03-31 2022-12-28 Global Life Sciences Solutions Operations UK Ltd Améliorations dans et se rapportant à des collecteurs d'échantillon biologique et la manipulation de ce dernier
US11459601B2 (en) 2017-09-20 2022-10-04 Altratech Limited Diagnostic device and system
US12553078B2 (en) 2017-09-20 2026-02-17 Altratech Limited Diagnostic device and system

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