130 C urrent A llergy & C linical Im m unology, A ugust 2007 Vol 20, N o.

3
Robin J Green, PhD
D epartm ent of Paediatrics and Child H ealth, U niversity
of Pretoria, South Africa
Paul C Potter, M D
U CT Lung Institute, Cape Tow n, South Africa
INTRODUCTION
The incidence of adverse drug reactions is w idely quot-
ed as about 15% of all hospitalised patients.
1,2
H ow ever, this total includes m any non-allergic reac-
tions in both susceptible and non-susceptible individu-
als. A t m ost 5% of individuals have allergic drug reac-
tions, of w hich antibiotic allergy is by far the m ost fre-
quent event. Few studies of the incidence of adverse
drug reactions in intensive care units (IC U s) are avail-
able. H ow ever, a recent report of cutaneous adverse
drug reactions in an IC U has been published.
3
The
authors report on an 8-m onth period in an adult IC U .
The incidence of adverse drug reactions of a cutaneous
nature w as 11.6% . R isk factors identified w ere fem ale
gender, obesity, age over 60 and im m une dysregula-
tion (system ic lupus, dysthyroidism and anti-phospho-
lipid antibody syndrom e). A ntibiotics w ere the m ain
drug involved and few patients had a previous history
of drug reaction. Patients w ho had anaphylactic events
had a poor prognosis. The risk factors are com m only
reported (Table I).
O f all drug and antibiotic allergic reactions, allergy to
beta-lactam s is the m ost com m on reaction.
4
Penicillin
reactions are usually explained by either IgE or T-cell
dependent responses. B enzylpenicillin is no longer the
m ost frequently prescribed antibiotic, especially in the
IC U , and therefore new er antibiotic allergies have
evolved.
Im m ediate hypersensitivity reactions to antibiotics are
IgE m ediated and characterised by the im m ediate
release of inflam m atory m ediators from m ast cells
resulting in anaphylaxis, urticaria and angio-oedem a.
5
B eta-lactam allergy is com m on enough for m ost clini-
cians to have an approach to this condition but other
drug allergies are less com m on, less often diagnosed,
often lack validated diagnostic tests and are usually
m anaged poorly.
This review focuses on the various diagnostic tests as
w ell as therapeutic strategies to deal w ith antibiotic
allergy in the IC U setting.
SUSPECTING ANTIBIOTIC ALLERGY
B ased on the risk factors, the m ost im portant state-
m ent regarding clinical presentation of drug allergy is
that a high index of suspicion is the m ost useful clue.
N early every clinical sign or abnorm al laboratory test
has drug allergy in its differential. A useful clinical guide
is that IgE-m ediated reactions usually present w ithin
30 m inutes of drug adm inistration and usually have
skin (urticarial, angio-oedem a), gastro-intestinal (diar-
rhoea or vom iting), respiratory (bronchospasm ) or sys-
tem ic (shock, hypotension) features. D elayed reactions
suggest another im m une m echanism for allergy.
Testing for suspected antibiotic allergy
M any clinical features of drug allergy in patients in an
IC U setting m ay be attributable to other causes, or
drugs other than antibiotics, and hence the approach of
trying to confirm allergy is useful. W ohrl and col-
leagues
6
reported on a cohort of 291 individuals w ith
suspected drug allergy. A ll patients had a detailed his-
tory, skin-prick testing (SPT) or specific IgE and provo-
cation testing. A lthough this w as not an IC U study they
w ere able to offer clear-cut recom m endations on drug
allergy, avoidance and alternatives to 82.1% of
patients, clearly show ing the usefulness of testing
strategies. In addition the IC U patient frequently har-
bours an organism that has m ultiple antibiotic resis-
tance patterns and dem ands use of a drug despite sus-
pected allergy. In addition som e disease states have
few or no alternative drug selections.
ANTIBIOTIC ALLERGY IN THE INTENSIVE
CARE UNIT
C orrespondence: Prof R G reen, PO B ox 67, Pretoria 0001. E-m ail
robingreen@ up.ac.za
ABSTRACT
D rug allergy in an intensive care unit (IC U ) m ay be
m ore com m on than realised. A ntibiotics are the
m ain drug involved and few patients have a previous
history of drug reaction. O f all drug and antibiotic
allergic reactions, allergy to beta-lactam s is the m ost
com m on reaction. B eta-lactam allergy is com m on
enough for m ost clinicians to have an approach to
this condition but since other drug allergies are less
com m on, less often diagnosed, and often lack vali-
dated diagnostic tests, they are usually m anaged
poorly. B ased on the risk factors, the m ost im portant
statem ent regarding clinical presentation of drug
allergy is that a high index of suspicion is the m ost
useful clue to suspected allergy. Testing strategies
need to confirm allergy and skin-prick testing is use-
ful in m any circum stances. Treatm ent of a proven
antibiotic allergy m ay include avoidance, but
because the IC U patient frequently harbours an
organism that has m ultiple antibiotic resistance pat-
terns and dem ands use of a drug despite suspected
allergy, m ethods of desensitisation should be
know n.
Table I. Risk factors for antibiotic allergy
Increasing age uncom m on in children
Fem ale sex
Intravenous adm inistration
O besity
Im m une disorders including H IV-positive individuals
C ystic fibrosis
M ultiple adverse events to m any drugs
A topy is not generally a risk factor
Previous reactions are uncom m on
Today a w ider selection of tests are available for testing
for antibiotic allergy. The four m ain tests are specific
R A ST testing, specific C A ST testing, skin-prick testing
and m easurem ent of serum tryptase.
Specific radio-allergosorbent test (RAST)
W hile R A STs are available to a w ide range of inhalant
and food allergens only a few antibiotic tests are
offered. They are reflected in Table II.
U nfortunately the R A STs for penicillin m easure only the
m ajor determ inant of penicillin. The m inor determ inant
is an im portant cause of anaphylaxis and therefore ana-
phylactic reactions cannot be excluded by negative
penicillin R A ST. R A ST testing has a useful negative pre-
dictive value in excluding future allergic reactions in
negative patients. H ow ever positive predictive value is
poor.
Cellular antigen stimulation test (CAST)
The C A ST is useful for detecting non-IgE-m ediated
sensitivity to certain drugs. It can also confirm IgE-
m ediated sensitivity, but in general, specific IgE tests,
such as SPTs and the C A P R A STs are m ore efficient in
this regard.
Principle of the CAST
The C A ST depends on the exposure of interleukin-3
prim ed fresh basophils to different concentrations of
an allergen, drug or chem ical. B asophils w hich are sen-
sitive to such exposure release sulphido leukotrienes
into the m edia. These released leukotrienes are m ea-
sured by an enzym e-linked im m unosorbent assay
(ELISA ). The C A ST thus m easures both IgE- and non-
IgE-m ediated leukotriene release in the ELISA .
C ut-off values for non-specific leukotriene release have
been determ ined by exposing ( 20) healthy (non-aller-
gic and non-sensitive) adult individuals to the agents,
determ ining background release in this w ay. Patients
w ho are clinically sensitive release leukotrienes in lev-
els above the norm al controls.
7
The technical cut-off values are listed in Table III.
Requesting a CAST
A lim ited num ber of laboratories conduct the C A ST in
South A frica. For a C A ST a full history of specific expo-
sure in relation to clinical sym ptom s should be provid-
ed to the laboratory to assist selection of the m ost like-
ly allergenin a cost-effective w ay.
A fresh sam ple of ED TA blood is required (2 x 4 m l
specim ens) and this should reach the laboratory in the
m orning on w hich the test is to be conducted, prefer-
ably w ithin 3 hours of taking the blood sam ple. Patients
should be off all oral steroids for 48 hours prior to the
test. It is also preferable to investigate the patients 3
w eeks after a severe adverse reaction.
Patients m ay be brought to the laboratory w here blood
is taken freshly and the patient can also be interview ed
to assist intelligent selection of the m ost appropriate
C A ST reagent. It is also im portant to ensure that
patients are not on oral or injected steroids w ithin 2
w eeks of conducting a C A ST on their basophils.
The result of a C A ST is usually available w ithin 24
hours and it is our policy to discuss each result w ith the
patient and to provide specific w ritten inform ation to
facilitate avoidance of the allergen/preservative/addi-
tive/drug to w hich the patient is found to be sensitive.
This form of testing is becom ing increasingly useful for
patients w ith antibiotic reactions; how ever borderline
or low values m ay not exclude patients w ith potential
life-threatening reactions on challenge testing.
Skin-prick testing (SPT)
SPT is available only for beta-lactam antibiotics. B oth
m ajor and m inor determ inants of penicillin should be
tested.
8
C urrently the tem porary com m ercial unavail-
ability of Pre-Pen (penicilloyl polylysine) m akes SPT to
this m ajor determ inant difficult. M inor determ inant
C urrent A llergy & C linical Im m unology, A ugust 2007 Vol 20, N o. 3 131
Table II. Antibiotic RASTs
Penicilloyl G c1
Penicilloyl V c2
A m oxicilloyl c6
A m picilloyl c5
C efachlor R c7
Table III. Technical cut-off values for CAST
Code Allergen Conc. in cell stimulation Technical cut-off
pg/ml sLT
ANTIBIOTICS
B A G 2-C 1 Penicillin G 500 g 50
B A G 2-C 2 Penicillin V 500 g 40
B A G 2-C 11 PPL (B enzylpenicilloyl-polylysine) 5 g 110
B A G 2-C 12 M D M (M inor determ inant m ixture) 100 g 100
B A G 2-C 203 A m picillin 2 m g 70
B A G 2-C 204 A m oxicillin 200 g 100
B A G 2-C 3 C ephalosporin C 20 g 40
B A G 2-C 31 C efam andole 500 g 80
B A G 2-C 32 C efazolin 500 g 80
B A G 2-C 33 C efuroxim e 500 g 40
B A G 2-C 61 Sulfam ethoxazole 20 g 50
B A G 2-C 62 Trim ethoprim 20 g 40
B A G 2-C 75 Tetracycline 20 g 90
B A G 2-C 81 C iprofloxacin 20 g 90
testing is also im portant. M D M can be m ade by diluting
fresh Penicillin G w ith 2-w eek-old penicillin, 10 000
U /m l. A protocol for penicillin SPT is described in Table
IV. O ther protocols are available from the authors.
Serum tryptase
The patient w ho has a sudden severe episode of shock
in the IC U or theatre is often considered to have had an
anaphylactic reaction to a drug. H ow ever, m any causes
exist and these com plicate the diagnosis especially in
patients w ho have been ill w ith various conditions prior
to drug adm inistration. A useful test to separate out ana-
phylactic from other 'anaphylactoid' events is serum
tryptase. This m easurem ent should be done im m edi-
ately follow ing the reaction, w hen a peak in levels is
expected, and then som e 6 hours later w hen return to
baseline should occur. Tryptase seem s not to be a use-
ful m easure after drug-provocation test reactions.
9
Oral provocation testing
Som e antibiotics have no gold-standard diagnostic test-
ing available and oral provocation m ay serve as the gold
standard. Such agents include m etronidazole and
erythrom ycin.
10
TREATING ANTIBIOTIC ALLERGY IN THE
ICU
The diagnostic w ork-up suggested above is im portant
for the IC U patient w ith suspected antibiotic allergy
because often that antibiotic is the last antibiotic to
w hich highly resistant organism s m ay still be sensitive
or alternatives m ay not be available.
G eneral principles of m anagem ent of anaphylactic drug
reactions are listed in Table V.
1
A frequent question in practice is the use of
cephalosporins in patients w ith penicillin allergy. This
topic w as the subject of a recent m eta-analysis.
11
These authors review ed 219 articles and com m ented
on 9. A lthough the description of penicillin allergy diag-
nosis varied am ong studies they found a significant
cross-allergy betw een penicillins and first-generation
cephalosporins but this is negligible w ith second- and
third-generation cephalosporins. They concluded w ith
the statem ent that in selecting such a substitute antibi-
otic, particular em phasis should be placed on the chem -
ical structure sim ilarities betw een the reacting drug and
proposed substitute. A third- or fourth-generation
cephalosporin m ay be an acceptable substitute in the
IC U setting for penicillin-allergic patients w ho have
m inor reactions but should be considered only in spe-
cial situations in individuals w ho have had a docum ent-
ed anaphylactic reaction to penicillin. A recom m enda-
tion is that before using any cephalosporin in a peni-
cllin-sensitive patient, SPT to the proposed
cephalosporin should be used at concentrations of
25 m g/m l (w ith positive and negative controls) to con-
firm that the patient is not sensitive. There is a 95%
negative predictive value to this test. This could have
m edicolegal significance as som e w ould argue that no
patient w ith penicillin allergy is com pletely safe from
reactions to any generation of cephalosporin.
O ther antibiotics containing beta-lactam rings, such as
m onobactam s (aztreonam ), have no significant cross-
reactivity w ith penicillins, and recently im ipenem has
been show n to be tolerated by penicillin and beta-lac-
tam allergic patients.
12
Desensitisation for antibiotic allergy
D esensitisation for drug allergy is the induction of tem -
porary clinical unresponsiveness to drug allergens.
12
G radual re-introduction of sm all doses of drug allergen
at fixed tim e intervals allow s the delivery of full thera-
peutic doses protecting against anaphylaxis. The cellu-
lar and m olecular inhibitory m echanism s are not w ell
understood but the suggestion is that intracellular sig-
nalling pathw ays w ithin m ast cells and basophils
becom e inhibited.
12
Such protocols are available for com m on drugs (Tables
VI-IX) including penicillin, cephalosporins, carbapen-
em s, vancom ycin and sulphas. M ost of these protocols
apply to adult patients w hile the techniques are seldom
em ployed in children.
O nly im m ediate type I reactions to penicillin and beta-
lactam s are am enable to rapid desensitisation. O ther
reactions such as m aculopapular rashes, erythem a
m ultiform e, Stevens Johnson syndrom e, toxic epider-
m al necrolysis, bullous erythem a, erythroderm a, serum
sickness, haem olytic anaem ia, neutropenia, throm bo-
cytopenia, and acute interstitial nephropathy are not
am enable to rapid desensitisations.
12
132 C urrent A llergy & C linical Im m unology, A ugust 2007 Vol 20, N o. 3
Table IV. Penicillin SPT protocol
1. Pre-Pen in increasing quantities of diluted concen-
trations 1:1 000, 1:100, 1:10 follow ed, if negative,
by intraderm al test
2. M D M in increasing quantities of diluted concentra-
tions as above
3. R eaction m easurem ent: positive if > 5 m m w heal
size
4. A lw ays use a positive (histam ine) and negative
(saline) control
5. SPT should be perform ed in an IC U setting even for
non-IC U patients
Table V. Principles of managing anaphylactic
drug reactions
1. Stop the antibiotic adm inistration im m ediately
2. Treat the patient for the circulatory collapse and
bronchospasm by standard m eans.
3. Intram uscular or intravenous adrenaline rem ains
the m ainstay of treatm ent.
4. A dvise drug avoidance w here possible
5. A dvise cross-reacting drug avoidance w here possi-
ble
6. O n discharge the patient should receive a M edic-
alert disc.
7. D esensitise if the drug is absolutely required
Table VI. Penicillin desensitisation protocol
A typical protocol for desensitisation to intravenous
penicillin and cephalosporins starts at 1:10 000 to
1:100 the target dose, and doubling doses are deliv-
ered every 15-20 m inutes over the course of several
hours until the target dose is reached.
12
A ll patients should be given an H 1-antihistam ine during
the desensitisation process. The role of steroids is con-
troversial.
Sulfa hypersensitivity in patients with HIV
infection
Sulfam ethoxazole/trim ethoprim (SM X-TM P) is the
m ost effective m edication for treatm ent and preven-
tion of Pneum ocystis jerovicii pneum onia (PC P) in
patients w ith A ID S. In m any sectors of practice in
South A frica it is the only available agent. H ow ever,
adverse events are frequently reported. In m ost
patients using SM X/TM P skin reactions occur. In m ost
patients the drug is stopped but there is new evidence
that this drug needs to be stopped only in severe cases
(Table X).
In patients w ith defined allergy, desensitisation can be
perform ed. In IC U s that treat PC P in H IV-positive chil-
dren this m ethod is som etim es im portant to be able to
continue life-saving therapy (Table XI). D esensitisation
can restore tolerability in approxim ately tw o-thirds of
patients w ho use it.
15
C urrent A llergy & C linical Im m unology, A ugust 2007 Vol 20, N o. 3 133
Table VII. Ceftazidime desensitisation protocol
1. 50 m g over 6-8 hours IV infusion
2. 750 m g over 6-8 hours IV infusion
3. 1 g over 6-8 hours IV infusion
4. Full dose (100 m g/kg/day) over 24 hours
Table VIII. Piperacillin/tazobactam desensitisation
protocol
1. 100 m g over 6 hours IV infusion
2. 500 m g over 6 hours IV infusion
3. 2 g over 6 hours IV infusion
4. Full dose (10 m g/kg/day) over 24 hours
Table IX. Vancomycin desensitisation protocol
13
Day Time Concentration Infusion rate Cumulative dose from
(min) (mg/ml) (mg/min) the start (mg)
Rapid desensitisation
1 0-10 0.0001 0.0001 0.001
10-20 0,001 0.00033 0.004
20-30 0.001 0.001 0.014
30-40 0.01 0.0033 0.047
40-50 0.01 0.01 0.15
50-60 0.1 0.033 0.48
60-70 0.1 0.1 1.48
70-80 1 0.33 4.8
80-90 1 1 14.8
90-100 10 2.2 36.8
100-110 10 4.4 80.8
Slow desensitisation
1 110-215 10 4.4 500
2 0-300 1 1.7 500
3 0-300 1 1.7 500
4 0-300 1 1.7 500
5 0-300 1 1.7 500
6 0-300 2 3.3 1000
7 0-300 2 3.3 1000
8 0-300 2 3.3 1000
9 0-300 3 5.0 1500
10 0-300 3 5.0 1500
11 0-300 3 5.0 1500
12 0-300 3 5.0 1500
13 0-300 3 5.0 1500
14 0-300 4 6.7 2000
15 0-300 4 6.7 2000
16 0-300 4 6.7 2000
17 0-300 4 6.7 2000
18 0-300 4 6.7 2000
19 0-300 4 6.7 2000
20 0-300 4 6.7 2000
21 0-300 4 6.7 2000
22 0-300 4 6.7 2000
23 0-300 4 6.7 2000
24 0-300 4 6.7 2000
25 0-300 4 6.7 2000
26 0-300 4 6.7 2000
27 0-300 4 6.7 2000
28 0-300 4 6.7 2000
CONCLUSION
A ntibiotic allergy in the IC U is becom ing an im portant
topic w ith the em ergence of m ultiresistant organism s
and lim itations in antibiotic selections. W e should have
an approach to confirm ing suspected allergy and not
sim ply stop or change antibiotics w ithout proof. In addi-
tion protocols are now available to restore tolerance to
antibiotics in patients w ith severe allergic reactions.
These how ever should in the m ain be em ployed in an
IC U setting to lim it the possibility of adverse reactions.
Declaration of conflict of interest
The authors declare no conflict of interest.
REFERENCES
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4. R odriques-Pena R , A ntunez C , M artin E, B lanca-Lopez N , M ayorga
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sensitivity reactions to penicillins and other betalactam s. Curr
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6. W ohrl S, Vigl K, Stingl G . Patients w ith drug reactions is it w orth
testing? Allergy 2006; 61: 928-934.
7. Potter PC . C linical indications and interpretation of the C A ST.
Current Allergy & Clinical Im m unology 2006; 19: 14-17.
8. Schafer JA , M ateo N , Parlier G L, R otschafer JC . Penicillin allergy
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545.
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severity m arker in drug provocation tests. Int Arch Allergy Im m unol
2006; 140: 164-169.
10. G arcia-R ubio I, M artinez-C ocera C , Santos M agadan S, R odriques-
Jim enez B , Vasquez-C ortes S. H ypersensitivity reactions to
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13. Kitazaw a T, O ta Y, Kada N , M orisaw a Y, Yoshida A , Koike K, Kim ura
S. Successful vancom ycin desensitization w ith a com bination of
rapid and slow infusion m ethods. Int M ed 2005; 45: 317-321.
14. M otala C . D rug-induced adverse reactions in H IV and A ID S.
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15. R yan C , M adalon M , W ortham D W , G raziano FM . Sulfa hypersen-
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134 C urrent A llergy & C linical Im m unology, A ugust 2007 Vol 20, N o. 3
Table X. Indications to stop SMX-TMP
14
Persistent rash or fever > 5 days
A bsolute neutrophil count < 500/m m
3
H ypotension/dyspnoea
B listering desquam ation/m ucus m em brane involve-
m ent
Table XI. SMX-TMP desensitisation
Day Dose SMX-TMP
1 1 m l of 1:20 paediatric suspension of SM X-
TM P 0.4 m g/2 m g
2 2 m l of 1:20 paediatric suspension of SM X-
TM P 0.8 m g/4 m g
3 4 m l of 1:20 paediatric suspension of SM X-
TM P 1.6 m g/8 m g
4 8 m l of 1:20 paediatric suspension of SM X-
TM P 3.2 m g/16 m g
5 1 m l of paediatric suspension of SM X-TM P
8 m g/40 m g
6 2 m l of paediatric suspension of SM X-TM P
16 m g/80 m g
7 4 m l of paediatric suspension of SM X-TM P
32 m g/160 m g
8 8 m l of paediatric suspension of SM X-TM P
64 m g/320 m g
9 1 tablet of SM X-TM P 80 m g/400 m g
10 1 tablet of double-strength (D S) SM X-TM P
160 m g/800 m g
Thereafter 1 tablet of D S SM X-TM P on M onday,
W ednesday, and Friday for PC P prophylaxis or 2
tablets a day for the treatm ent of isosporiasis.
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