- Email: [email protected]
HCV confirmatory testing of blood donors
372
breakdowns, without being the cause of them. More importantly, badger TB dies out naturally, as it did in former "black spots" in the midlands counties of England, when not topped up by recurrent herd breakdowns. The assumptions underlying the policy of badger culling are false and the money would be better spent on research focused on a more positive solution to what is essentially a bovine disease (eg, an ELISA test for cattle or a vaccine). 72
Bisley Old Road, Stroud GL5 1NB, UK
M. HANCOX
Nelson J. Causes of ill health and natural death in badgers in Gloucestershire. Vet Rec 1979, 105: 546-51. 2. Laplaud PM. A year long study of changes induced by castration in the plasma lipid and lipoprotein spectrum in the European badger. Atherosclerosis 1986; 61: 43-55 3. Francis J. Tuberculosis in animals and man. London: Cassell, 1958 4. Yates MD, Grange JM. Incidence and nature of human tuberculosis due to bovine tubercle bacilli in southeast England. Epidemiol Infect 1988; 101: 225-29 5. Cheeseman CL, Wilesmith JW, Stuart FA. Tuberculosis: the disease and its epidemiology in the badger. Epidemiol Infect 1989; 103: 113-25. 6. Pritchard DG, Stuart FA, Brewer JI, Mahmood KH. Experimental infection of badgers with Mycobacterium bovis. Epidemiol Infect 1987; 98: 145-54. 1.
Gallagher J,
Female
important determinant of lisinopril-induced cough
sex as an
well-recognised side-effect of angiotensinconverting enzyme (ACE) inhibitors; it usually appears during the first 2-3 months of therapy and may lead to withdrawal of the drug. In a Norwegian multicentre comparison of nifedipine with lisinopril in mild-to-moderate hypertension1 828 patients took part. The design was double-blind, double-dummy, parallel, and
SIR,-Cough
is
In
our
blood transfusion centre, of 126 donations that
were
repeatedly HCV positive by ELISA (Ortho, second generation) 19 (15%) were RIBA-2 confirmed, 42 (33%) were indeterminate, and 51-6% were negative. Of the 42 "indeterminate" donors 25 were seen again 1-12 weeks (median 3 weeks) after the first donation. RIBA-2 tests on the second samples do not suggest that donors from the west of France whose samples are labelled RIBA-2 indeterminate (C22, C33, or C100 only) are usually in a phase of early HCV seroconversion: RIBA-2
RIBA-2
reactivity in lst sample
reactivity in 2nd sample
a
randomised with active treatment for 10 weeks after a 4-week run-in
placebo period. Of the 412 patients randomised to lisinopril (average dose 18-8 mg) 8-5% reported cough spontaneously, compared with only 3-1% of 416 patients on nifedipine (37-4 mg) (p = 0 0009). Nearly three times more women than men spontaneously reported cough with lisinopril (12-6% vs 4-4%, p=00027), whereas such a difference was not apparent with nifedipine (2 -8 % vs 30%). In the male patients there seemed to be no difference in the frequency of cough between lisinopril and nifedipine (4.4% vs 30%; not significant [NS]). The female preponderence has been noted with other ACE inhibitors.2-4 In 5 patients, all women, cough contributed in part to withdrawal from the study. Non-smokers (72%) and smokers (28%) reported spontaneously similar frequency of cough with lisinopril (9-5% vs 8-1%; NS). When asked specifically about cough, smokers reported the symptom more often at baseline (placebo) than non-smokers (27-6% vs 12-2%; p=0-0002). When the specific question was asked, however, the increase from baseline in cough after lisinopril was more pronounced for non-smokers than for smokers (16% vs 7%; p =0-0188). Thus, cough caused by lisinopril seems to be more common in women
HCV confirmatory testing of blood donors SIR,-Dr Follet and colleagues (Oct 19, p 1024) note the difficulty of confirming second-generation ELI SAs for detection of blood donors positive for hepatitis C virus (HCV) antibodies, and suggest that Ortho recombinant immunoblot assay (RIBA-2) indeterminate samples should be routinely tested by the polymerase chain reaction (PCR). Dr Chan and colleagues (Nov 30, p 1391) highlighted the need for vigorous exclusion from transfusion of PCR-negative, RIBA-2 indeterminate donations that are reactive with C22 only.
’"’-’
’B
The commercial
,
,
availability of the
’UBI HCV ELISA’ (Organon) screening test and the ’Liatek HCV’ (InnogeneticsOrganon) confirmatory test kits provide the opportunity to evaluate serum samples previously tested by ELISA and RIBA-2. Of the 126 ELISA positive samples only 25 were reactive by the UBI test. All 19 RIBA-2 positive but only 95% of the indeterminate and 3-1% of the negative samples were UBI positive. The first and second samples of the 25 RIBA-2 indeterminate donors were tested by both the new kits. Only 1 was positive by UBI screening ELISA (donor A) and 2 by the confirmatory kit (positive one or more HCV antigen lines with a 2 + or higher rating or two or more lines with a 1 + or higher rating) (B and C). The identical reactivity for the first and second samples supports the unchanged RIBA-2 results: =
2nd sample UBI Liatek
1 st sample UBI Liatek
Delay between Ortho
Ortho
1 st and 2nd
UBI
Sample ELlSA* RIBA-2t ELlSA*
sample (wk)
Liatekt
and non-smokers.
Department of Nephrology, Ullevål Hospital, Oslo, Norway
INGRID OS
Grangården Medical Centre, Arendal
BJØRN BRATLAND
Ostra Sjukhuset,
Gothenburg, Sweden
BJÖRN DAHLÖF
Nesttun, Norway
KJELL GISHOLT
Øreåsen Medical Centre, Moss
JAN OTTO SYVERTSEN
Bærum Verk
STEINAR TRETLI
1. Os I, Bratland B, Dahløf, Gisholt K, Syvertsen JO, Tretli S. Lisinopril or nifedipine in
essential hypertension?: a Norwegian multicenter study on efficacy, tolerability and quality of life in 828 patients. J Hypertens 1991; 9: 1097-104. 2 Gibson GR. Enalapril-induced cough. Arch Intern Med 1989; 149: 2701-03. 3. Coulter DM, Edwards IR. Cough associated with captopril and enalalpril. Br Med J 4.
1987, 294: 1521-23. Yeo WW, Maclean D, Richardson PJ, Ramsay LE. Cough and enalapril: assessment by spontaneous reporting and visual analogue scale under double-blind conditions. Br J Clin Pharmacol 1991, 31: 356-59
*As sample/cut-off ratio tBands scored (- to 4)
(strong positive) according
to
manufacturers’
bands 5-1-1, C-100, and C-33 consistentlytBands scored (- - to 4), bands NS4, NSS, C1 (core oligopeptide 1-4), and instructions,
C3 consistently These data show that most C22 RIBA-2 indeterminate blood donors in our area are not implicated in early anti-HCV seroconversion, and these serum samples were non-reactive in a new commercially available screening kit and confirmatory test. We hope that these samples are showing false C22 positives or C22 positives not involved in hepatitis transmission because they will be missed by new blood donor HCV antibody screening tests.
Centre de Transfusion Sanguine, 44011 Nantes, France
DANIEL BOUDART JEAN-CLAUDE LUCAS CHANTAL ADJOU
JEAN-YVES MULLER
breakdowns, without being the cause of them. More importantly, badger TB dies out naturally, as it did in former "black spots" in the midlands counties of England, when not topped up by recurrent herd breakdowns. The assumptions underlying the policy of badger culling are false and the money would be better spent on research focused on a more positive solution to what is essentially a bovine disease (eg, an ELISA test for cattle or a vaccine). 72
Bisley Old Road, Stroud GL5 1NB, UK
M. HANCOX
Nelson J. Causes of ill health and natural death in badgers in Gloucestershire. Vet Rec 1979, 105: 546-51. 2. Laplaud PM. A year long study of changes induced by castration in the plasma lipid and lipoprotein spectrum in the European badger. Atherosclerosis 1986; 61: 43-55 3. Francis J. Tuberculosis in animals and man. London: Cassell, 1958 4. Yates MD, Grange JM. Incidence and nature of human tuberculosis due to bovine tubercle bacilli in southeast England. Epidemiol Infect 1988; 101: 225-29 5. Cheeseman CL, Wilesmith JW, Stuart FA. Tuberculosis: the disease and its epidemiology in the badger. Epidemiol Infect 1989; 103: 113-25. 6. Pritchard DG, Stuart FA, Brewer JI, Mahmood KH. Experimental infection of badgers with Mycobacterium bovis. Epidemiol Infect 1987; 98: 145-54. 1.
Gallagher J,
Female
important determinant of lisinopril-induced cough
sex as an
well-recognised side-effect of angiotensinconverting enzyme (ACE) inhibitors; it usually appears during the first 2-3 months of therapy and may lead to withdrawal of the drug. In a Norwegian multicentre comparison of nifedipine with lisinopril in mild-to-moderate hypertension1 828 patients took part. The design was double-blind, double-dummy, parallel, and
SIR,-Cough
is
In
our
blood transfusion centre, of 126 donations that
were
repeatedly HCV positive by ELISA (Ortho, second generation) 19 (15%) were RIBA-2 confirmed, 42 (33%) were indeterminate, and 51-6% were negative. Of the 42 "indeterminate" donors 25 were seen again 1-12 weeks (median 3 weeks) after the first donation. RIBA-2 tests on the second samples do not suggest that donors from the west of France whose samples are labelled RIBA-2 indeterminate (C22, C33, or C100 only) are usually in a phase of early HCV seroconversion: RIBA-2
RIBA-2
reactivity in lst sample
reactivity in 2nd sample
a
randomised with active treatment for 10 weeks after a 4-week run-in
placebo period. Of the 412 patients randomised to lisinopril (average dose 18-8 mg) 8-5% reported cough spontaneously, compared with only 3-1% of 416 patients on nifedipine (37-4 mg) (p = 0 0009). Nearly three times more women than men spontaneously reported cough with lisinopril (12-6% vs 4-4%, p=00027), whereas such a difference was not apparent with nifedipine (2 -8 % vs 30%). In the male patients there seemed to be no difference in the frequency of cough between lisinopril and nifedipine (4.4% vs 30%; not significant [NS]). The female preponderence has been noted with other ACE inhibitors.2-4 In 5 patients, all women, cough contributed in part to withdrawal from the study. Non-smokers (72%) and smokers (28%) reported spontaneously similar frequency of cough with lisinopril (9-5% vs 8-1%; NS). When asked specifically about cough, smokers reported the symptom more often at baseline (placebo) than non-smokers (27-6% vs 12-2%; p=0-0002). When the specific question was asked, however, the increase from baseline in cough after lisinopril was more pronounced for non-smokers than for smokers (16% vs 7%; p =0-0188). Thus, cough caused by lisinopril seems to be more common in women
HCV confirmatory testing of blood donors SIR,-Dr Follet and colleagues (Oct 19, p 1024) note the difficulty of confirming second-generation ELI SAs for detection of blood donors positive for hepatitis C virus (HCV) antibodies, and suggest that Ortho recombinant immunoblot assay (RIBA-2) indeterminate samples should be routinely tested by the polymerase chain reaction (PCR). Dr Chan and colleagues (Nov 30, p 1391) highlighted the need for vigorous exclusion from transfusion of PCR-negative, RIBA-2 indeterminate donations that are reactive with C22 only.
’"’-’
’B
The commercial
,
,
availability of the
’UBI HCV ELISA’ (Organon) screening test and the ’Liatek HCV’ (InnogeneticsOrganon) confirmatory test kits provide the opportunity to evaluate serum samples previously tested by ELISA and RIBA-2. Of the 126 ELISA positive samples only 25 were reactive by the UBI test. All 19 RIBA-2 positive but only 95% of the indeterminate and 3-1% of the negative samples were UBI positive. The first and second samples of the 25 RIBA-2 indeterminate donors were tested by both the new kits. Only 1 was positive by UBI screening ELISA (donor A) and 2 by the confirmatory kit (positive one or more HCV antigen lines with a 2 + or higher rating or two or more lines with a 1 + or higher rating) (B and C). The identical reactivity for the first and second samples supports the unchanged RIBA-2 results: =
2nd sample UBI Liatek
1 st sample UBI Liatek
Delay between Ortho
Ortho
1 st and 2nd
UBI
Sample ELlSA* RIBA-2t ELlSA*
sample (wk)
Liatekt
and non-smokers.
Department of Nephrology, Ullevål Hospital, Oslo, Norway
INGRID OS
Grangården Medical Centre, Arendal
BJØRN BRATLAND
Ostra Sjukhuset,
Gothenburg, Sweden
BJÖRN DAHLÖF
Nesttun, Norway
KJELL GISHOLT
Øreåsen Medical Centre, Moss
JAN OTTO SYVERTSEN
Bærum Verk
STEINAR TRETLI
1. Os I, Bratland B, Dahløf, Gisholt K, Syvertsen JO, Tretli S. Lisinopril or nifedipine in
essential hypertension?: a Norwegian multicenter study on efficacy, tolerability and quality of life in 828 patients. J Hypertens 1991; 9: 1097-104. 2 Gibson GR. Enalapril-induced cough. Arch Intern Med 1989; 149: 2701-03. 3. Coulter DM, Edwards IR. Cough associated with captopril and enalalpril. Br Med J 4.
1987, 294: 1521-23. Yeo WW, Maclean D, Richardson PJ, Ramsay LE. Cough and enalapril: assessment by spontaneous reporting and visual analogue scale under double-blind conditions. Br J Clin Pharmacol 1991, 31: 356-59
*As sample/cut-off ratio tBands scored (- to 4)
(strong positive) according
to
manufacturers’
bands 5-1-1, C-100, and C-33 consistentlytBands scored (- - to 4), bands NS4, NSS, C1 (core oligopeptide 1-4), and instructions,
C3 consistently These data show that most C22 RIBA-2 indeterminate blood donors in our area are not implicated in early anti-HCV seroconversion, and these serum samples were non-reactive in a new commercially available screening kit and confirmatory test. We hope that these samples are showing false C22 positives or C22 positives not involved in hepatitis transmission because they will be missed by new blood donor HCV antibody screening tests.
Centre de Transfusion Sanguine, 44011 Nantes, France
DANIEL BOUDART JEAN-CLAUDE LUCAS CHANTAL ADJOU
JEAN-YVES MULLER