INFRARED

THERMOMETER

HEALTH TECHNOLOGY ASSESSMENT SECTION

MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
012/2012
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DISCLAIMER
Technology review is a brief report, prepared on an urgent basis, which draws on
restricted reviews from analysis of pertinent literature, on expert opinion and / or
regulatory status where appropriate. It has not been subjected to an external review
process. While effort has been made to do so, this document may not fully reflect all
scientific research available. Additionally, other relevant scientific findings may have
been reported since completion of this review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS)

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya

Tel: 603 88831246

Fax: 603 8883 1230

Available at the following website: http://www.moh.gov.my

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Prepared by
Madam Sin Lian Thye
Nurse/ Information Specialist
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

Dr. Junainah Sabirin

Principal Assistance Director
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

Reviewed by:
Datin Dr. Rugayah Bakri
Public Health Physician & Deputy Director
Health Technology Assessment Section (MaHTAS)
Ministry of Health Malaysia

DISCLOSURE

The author of this report has no competing interest in this subject and the preparation of
this report is totally funded by the Ministry of Health, Malaysia.

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EXECUTIVE SUMMARY

Introduction
Evaluation of body temperature is one of the oldest known diagnostic methods
and is still an important sign of health and disease, both in everyday life and in
medical care. Accurate temperature measurement is critically important, particularly in
neonates and immune compromised children whom suspicion of infection could result in
investigations, treatment and even hospitalization. Consequently, inaccurate body
temperature measurement may result in patients remain undiagnosed and untreated, or
receiving unnecessary or inappropriate intervention.

Pulmonary artery temperature is considered the “gold standard” for measuring core
body temperature. The distal esophagus and nasopharynx are considered acceptable
alternatives. Other methods for measuring core body temperature include rectal and
bladder measurement. However, all these methods are considered invasive procedures.
Clinically, oral and rectal temperatures are the most reliable indicators of core body
temperature.

This review was requested by the Senior Principle Assistant Director, Medical Services
Development Section, following a product demonstration by a Company.

Objective/aim
The objective of this systematic review was to assess the safety, efficacy/effectiveness
and cost-effectiveness of Infrared thermometer for fever detection in a hospital or
primary care setting.

Results and conclusions

Infrared tympanic thermometer in children
One systematic review and four diagnostic accuracy studies showed that infrared
tympanic thermometer temperature measurement better reflect the core body
temperature than axilla thermometer temperature measurement. It also showed that the
Infrared tympanic thermometer sensitivity and specificity was moderate. However, the
sensitivity and specificity increased with higher cut of point of temperature defined as
fever.

Infrared tympanic thermometer in adult

With respect to its use in adult population, there was fair level of evidence involving four
diagnostic accuracy studies that showed that infrared tympanic thermometer was less
accurate to reflect core body temperature than pulmonary artery catheter or mercury in
glass oral thermometer.

Non- contact infrared thermometer

Four studies were retrieved on the effectiveness of non-contact infrared thermometer in
children. The evidence found was inconclusive whereby two studies reported good
correlation of non-contact infrared thermometer with rectal/ mercury in glass axilla
thermometer but the other two studies did not show good correlation.

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Cost - effectiveness/Cost
The evidence showed that the infrared tympanic thermometer with lowest purchase
price has higher overall cost compared to the highest purchase price, This was because
of the increased cost of consumables (nearly double the price in the cheaper infrared
tympanic thermometer) that contributed to the total cost. In contrast, the cost of covers
of the expensive infrared tympanic thermometer was found to be cheaper.

Safety
There was no retrievable evidence reporting any adverse events related to the use of
the infrared thermometer.

Methods
Electronic databases were searched from inception: MEDLINE including MEDLINE In-
Process & Other Non-Indexed Citations (Ovid); PubMed; EBM Reviews, Cochrane
database of systematic; EBM Reviews - Health Technology Assessment; NHS
economic evaluation database. Searches were also run in Horizon Scanning database-
National Horizon Scanning Centre, Australia and New Zealand Horizon Scanning
Network, National Horizon Scanning Birmingham, EuroScan; FDA; MHRA. In addition to
the database searches, articles were identified from reviewing the bibliographies of
retrieved articles and hand searching of journals.

A combination of both controlled vocabulary, such as the National Library of Medicine‟s

MeSH (Medical Subject Headings), and keywords free text. The search strategies used
in MEDLINE were adapted for use in other databases. The search was limited by
including search filters for „human studies‟.

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 INFRARED THERMOMETER
1. INTRODUCTION

Evaluation of body temperature is one of the oldest known

diagnostic methods and is still an important sign of health and
disease, both in everyday life and in medical care. 1,2 Accurate
temperature measurement is critically important, particularly in neonates
and immune compromised children whom suspicion of infection could
result in investigations, treatment and even hospitalization.3,4
Consequently, inaccurate temperature measurement may result in
patients remain undiagnosed and untreated, or receiving unnecessary or
inappropriate intervention.5,6 In health centres and hospitals, nurses
are responsible for measuring body temperature accurately and it is
important to take into account the kind of thermometer and the sites
of the body used for taking the measurement. 7

Pulmonary artery temperature is considered the “gold standard” for

measuring core body temperature,8 as mixed venous blood temperature
reflects thermoregulation by the hypothalamus. The distal esophagus and
nasopharynx are considered acceptable alternatives to the pulmonary
artery catheter and commonly used intra-operatively.9, 10 However, like the
pulmonary artery catheter, these instruments are invasive and thus are
generally inappropriate outside the peri-anesthesia, peri-operative and
critical care setting. Other invasive methods include rectal and bladder
measurement. Clinically, oral and rectal temperatures are the most
reliable indicators of core body temperature.11,12 Children younger than
four years have difficulty keeping an oral thermometer under their
tongues, making reliable temperature measurements difficult. At present,
rectal thermometer has traditionally been considered the gold standard for
temperature measurement in young children because it correlates highly
with core body temperature.11,12,13 However, when the core temperature
increases or decreases abruptly, rectal temperature changes more slowly
and can be substantially different from the core temperature. In addition
without proper sterilization techniques, rectal thermometer has the
capacity to spread contaminants that are commonly found in stool. Rectal
thermometers are very stressful for infants, are time-dependent and
require certain level of practice. These characteristics make it an
undesirable procedure for infants, health workers and parents. 14

Mercury in glass thermometer was the traditional type of thermometer

used to measure body temperature. However, mercury thermometers are
gradually being phased out. This is because of concerns regarding the
toxic environmental effect of mercury, namely toxicity from the absorption
due to breakage and risk of infection.15,1 Thus, they are no longer
recommended for use in infants and young children.16,17 Furthermore, The
UK Health and Safety Regulations requires that mercury containing

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 medical devices should not be used whenever a suitable alternative
exists.18

Electronic thermometers are widely used by healthcare professionals as

alternative methods to mercury thermometers. This thermometer is
supposedly accurate and very quick to use but they are often complex and
quite expensive. Recently, cheaper compact electronic thermometers
have been produced and available for use by the public, as well as
healthcare professionals. Other types of thermometer available in the
market is the chemical phase change thermometers which uses a
combination of chemicals that change colour in response to variations in
temperature. This type of thermometer is either chemical dot
thermometers where the chemicals are contained in cells on a plastic
stick, or chemical forehead thermometers which consists of a patch of
chemicals in a plastic pouch that is placed on the forehead. Chemical dot
thermometers are usually designed for single use but reusable types are
also available. In recent years, infrared thermometers have been more
frequently used. This type of thermometer determines the temperature of
infrared emission from a source rather than absorbing heat from the tissue
and reaching thermal equilibrium with it. Temperatures can typically be
obtained in less than five seconds. Most thermometers of this type
measure temperature at the ear drum (infrared tympanic thermometers)
but temporal artery thermometers are now available where temperature is
measured on the scalp.15 Researchers have found a difference of 0.5 C
between the tympanic thermometer and the mercury-in-glass
thermometer.6, 19, 20

This review was requested by the Senior Principle Assistant Director,

Medical Services Development Section, following a product demonstration
by a company.

2. OBJECTIVE/AIM

The objective of this systematic review was to assess the safety,

efficacy/effectiveness and cost-effectiveness of Infrared thermometer for
fever detection in a hospital or primary care setting.

3. TECHNICAL FEATURES

3.1 Infrared ear thermometer

3.1.1 Mechanism of action

Infrared thermometers, also called tympanic thermometers, detect infrared

energy emanating from the ear canal and tympanic membrane. Often a
large number of measurements are performed rapidly to calculate the

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 temperature in the auditory canal. The tympanic membrane was initially
adopted as a measurement site because its blood supply from the internal
carotid artery was thought to reflect the temperature at the hypothalamus,
which regulates body temperature. However, the blood supply is more
complex than this, as the external carotid artery also supplies the
tympanic membrane. Further, the mechanism by which temperature is
controlled is not necessarily related to the temperature of the
hypothalamus.21 The thermometer probe, which is not in contact with the
tympanic membrane, contains optical sensors, usually thermopiles
(electronic devices that convert thermal energy into electrical energy) that
can detect infrared emissions. The received energy is converted into a
temperature reading.17 Infrared tympanic thermometers are licensed for
use in people of all ages, including babies and young children.

3.1.2 Technique for measurement

An appropriate disposable probe cover should be used. The nurse should

inspect the cover to ensure that it has been fitted correctly and that there
are no wrinkles over the tip end. This will ensure the most accurate
reading possible is achieved. The cover is also used to help keep the
probe tip clean and for infection control purposes. The temperature of ear
canal may be 2 C lower than the eardrum, therefore incorrect placing can
give falsely low temperature readings. The heat energy received by the
thermometer probe depends on the anatomy of the ear, the design of the
thermometer probe and where the probe is placed. The thermometer
calculates the patient‟s temperature from the infra-red energy received.
Some models apply an offset to the ear measurement to indicate the
temperature at a different site on the body, such as the oral site reading.
Correct measurement technique is very important to ensure reliable
temperature readings. With some patients and gentle but firm pull on the
ear may be required to straighten the ear canal. Alternatively, the tragus
may be gently retracted. The probe should be placed gently in the ear
canal ensuring a snug fit and aimed at the eardrum as shown in the
picture below.

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3.2 Non- contact temporal artery thermometer

This thermometer measure infrared emission from the temporal artery, it is

held just above the skin surface of the forehead and use a tracking light to
indicate the measurement area. As this type of thermometer can be used
to measure the temperature of a sleeping child, it is generally marketed for
home use.
This device does not come into contact with the patient, so the risk of
cross infection is reduced. Further, the running costs of the thermometer
are low because no disposable covers are required.

4. METHODS

4.1 Searching

Electronic databases were searched from inception: MEDLINE including

MEDLINE In-Process & Other Non-Indexed Citations (Ovid); Pubmed;
EBM Reviews, Cochrane database of systematic; EBM Reviews - Health
Technology Assessment; NHS economic evaluation database. Searches
were also run in Horizon Scanning database (National Horizon Scanning
Centre, Australia and New Zealand Horizon Scanning Network, National
Horizon Scanning Birmingham, EuroScan); FDA; MHRA.

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 In addition to the database searches, articles were identified from
reviewing the bibliographies of retrieved articles and hand searching of
journals.

A combination of both controlled vocabulary, such as the National Library

of Medicine‟s MeSH (Medical Subject Headings), and keywords free text.
Copies of the search strategies used in MEDLINE are included in
Appendix 1 (these were adapted for use in other databases). The search
was limited by including search filters for „human studies‟

4.2 Selection

A reviewer screened the titles and abstracts against the inclusion and
exclusion criteria and then evaluated the selected full-text articles for final
article selection.

The inclusion and exclusion criteria

Inclusion criteria
Patient Patient with fever or without fever
Intervention Infrared thermometer, infrared ear or tympanic thermometer,
non contact infrared thermometer
Comparator Mercury in glass thermometer
Chemical thermometer
Digital thermometer
No comparator
Outcome Fever detection, sensitivity, specificity, ROC, safety, adverse
events, economic evaluation
Study design Diagnostic accuracy studies, systematic review, health
technology assessment, cross sectional, randomised control
trial

Exclusion criteria

Studies conducted in animals and non- English full text article or abstract
only.

Relevant articles were critically appraised using Critical Appraisal Skills

Programme (CASP) and diagnostic studies was graded according to
NHS Centre for Reviews and Dissemination (CRD) University of York,
Report Number 4 (2nd Edition) as in Appendix 2

5. RESULT AND DISSCUSSION

One systematic review, one cost analysis study, 14 diagnostic studies

involving the use of infrared tympanic thermometer in various health

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 service environments ranging from primary care to intensive care were
identified. Out of these 14 studies, four studies involved adults and 10
studies involved children. Six diagnostic studies were identified for the use
of non-contact infrared thermometer in hospital.

5.1 Safety

There was no retrievable evidence on the adverse events related to the

use of infrared tympanic or non-contact infrared thermometer. Based on
the document submitted by the company, this infrared tympanic
thermometer or non-contact infrared had received TUV certification in
Taiwan and it is a class II b device.

5.2 Efficacy/Effectiveness

5.2.1 Infrared tympanic thermometer in children

Dodd et al performed a systematic review that evaluated diagnostic

accuracy by examining the sensitivity and specificity of the infrared
tympanic thermometer. Twenty three studies were included (n = 4,098
children), majority of the studies used 38°C as cut-off point for fever for
both rectal and tympanic temperatures. The pooled estimates 95%
confidence interval for sensitivity and specificity of infrared thermometer
were 63.7% (95% CI 55.6% to 71.8%) and 95.2% (95% CI 93.5% to
96.9%), respectively. Thus, infrared tympanic thermometer would fail to
diagnose three to four fever in every 10 febrile children (with fever defined
by a rectal temperature of 38 C or above).22, Level 2

Nimah et al conducted a study on 36 children (mean age = 20 months)

admitted to paediatric and cardiac intensive care units at Cincinnati
Children‟s Hospital Medical Center. Infrared tympanic, forehead sensor,
indwelling rectal probe and axilla digital thermometer temperature
measurement were compared with indwelling Foley Catheter bladder
Thermometer with sensor temperature measurement as reference
standard. It was found that tympanic temperature measurement was
more closely agreed with bladder temperature when using cut off point of
100.4 F (38 C) defined as fever, the mean difference of infrared
tympanic measurement was - 0.03 (1.43) F; sensitivity = 80%, specificity =
81% as compared to rectal temperatures with mean difference of - 0.62
(1.44)°F, sensitivity = 67%, specificity = 93%; but forehead temperature
revealed a mean difference of - 0.56 (±1.81) F, sensitivity = 57%;
specificity was 87%, while the mean difference of axillary temperatures
was -1.25 (±1.73)°F, sensitivity = 40%, specificity = 98%. The authors
discouraged the use of axilla thermometer in critically ill children and
stated that infrared tympanic thermometer was accurate, reliable, practical
and a less invasive substitute for bladder or rectal thermometer.23, level 2

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El-Radhi and Patel conducted a study among 106 infants attending an
accident and emergency department comparing tympanic temperature
measure by infrared tympanic thermometer and axilla temperature
electronic thermometer to those temperature measures by rectal
thermometer (device no stated). The study result found that the
agreement between rectal and tympanic temperatures appeared greater in
both afebrile children with the mean difference of 0.38°C (range 0.25°C to
0.50°C) and febrile children with the mean difference of 0.42°C (range
0.27°to 0.58°C). For infants with rectal temperature of 38°C to 38.9°C, the
sensitivity of infrared tympanic thermometer was 76%, while the sensitivity
of axilla electronic thermometer was 24%. Similarly, for infants with a
rectal temperature greater than 38.9°C, the sensitivity of infrared tympanic
thermometer was 100% and sensitivity for axilla electronic thermometer
was 89%. The authors concluded that infrared tympanic thermometer was
more accurate than axilla electronic thermometer and offered additional
practical benefits. 6, level 2

Musumba et al conducted study to compare infrared tympanic

thermometer and electronic axilla thermometer to rectal electronic
thermometer in 145 children with median age of 40 months admitted to a
Kilifi District Hospital with severe malaria. They found that 95% limit of
agreement mean difference for tympanic temperature measured by
infrared tympanic thermometer was 0.42°C (95% LOA -1.6°C to 2.44°C)
and axilla temperature measure by electronic thermometer was 0.74°C
(95% LOA -0.85°C to 2.33°C). The authors concluded that in children with
severe malaria, tympanic thermometer showed more accurate reflection of
the body temperatures at admission and it‟s should be preferably used
where available. 24,level 2

Sehgal et al study compared rectal and tympanic temperature in children

with signs and symptoms of meningitis at Emergency Division of Kalawati
Saran Children‟s Hospital. The found that the mean difference was 0.8 C
(sd = 0.5 C), p=0.001 in 60 children with signs and symptoms of
meningitis. While 60 children without signs and symptoms of meningitis,
the mean difference was 0.1 C (sd = 0.1 C), p>0.05). When examining a
range of rectal temperature of 38°C to 40°C as cut off point of fever,
temperature measurement by tympanic thermometer had a sensitivity of
100% throughout and specificity peaked at 89% when using 39.5 C as a
cut of point. The authors concluded that tympanic thermometer can
reliably predict core temperature over a wide range of readings.25, level 2

Study carried out by van Staaij et al compare between both left and right
ear temperature using infrared tympanic thermometer with rectal digital
thermometer among 41 children (with mean age of 5.9 years) admitted to
a general paediatric ward of a children hospital in Netherland. An analysis

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of variance revealed no statistically significant differences between right
tympanic, left tympanic or rectal temperatures. Right tympanic and rectal
temperature differed by more than 0.5°C in 10 children with the maximum
difference being 1.78°C. When fever was defined as a rectal temperature
of 38°C or greater, sensitivity and specificity were 93.3% and 92%
respectively. The authors concluded that infrared tympanic thermometer
was accurately reflects rectal temperature and validly assessed the
presence of fever in children.26, level 2

Jean-Mary et al conducted study among 198 children with mean age of

1.3 years attending a hospital-based primary care practice in Boston for
“well child” visits or acute illness to compare infrared tympanic and
infrared axilla thermometer temperature measurement with digital rectal
thermometer temperature measurement. The mean rectal temperature
was 100.2°F (range, 96.9°- 105.1°F). Sixty-three patients were considered
febrile, as defined by a rectal temperature ≥100.4° F, and 135 were
considered afebrile. When rectal fever defined as ≥ 100.4 F or greater, the
sensitivity and specificity for infrared axilla thermometer was 63.5% and
92.6% respectively (diagnostic accuracy was 83.3%); and infrared
tympanic thermometer was 68.3% and 94.8% respectively (diagnostic
accuracy was 86.4%). The authors concluded that for a healthcare visit in
the outpatient setting, the use of either of these devices was an
appropriate screening tool, but if the history or physical examinations
raised concerns for possible febrile illness, the rectal value should be used
for the purpose of clinical accuracy.27, level 2

Paes et al evaluated the accuracy of temperature measure by infrared

tympanic thermometer with digital rectal thermometer temperature
measurement in 100 children with mean age of 3.24 years admitted to
pediatric ward of Spaarne Hospital in The Netherlands. The mean
difference tympanic temperature reading was found to be 0.271°C (SD ±
0.573°C), and the Pearson correlation coefficient (R) were 0.827, there
was a strong correlation between rectal and tympanic correlation. When
rectal temperature used 38.0°C as cut-off point for fever defined, the
sensitivity and specificity for tympanic temperature measurement was
80% and 97% respectively; and positive predictive value was 91% and
negative predictive value 94%. The data suggested that the tympanic
thermometer is accurate in predicting rectal temperature. The SD of
differences between rectal temperature and temperature measured with
tympanic temperature was large. This indicates that the tympanic
thermometer is not able to predict rectal measurement.28, level 2

The above studies were summaries in table 1.

Devrim et al compared two different type of infrared tympanic thermometer

(home and clinical) to measure body temperature with axilla temperature

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 using mercury in glass thermometer among 102 children admitted to
general pediatric ward and neonatal intensive care unit in the Hacettepe
University Ihsan Dog ˘ramacı Children‟s Hospital. When axillary
temperatures used cut of point of >38.3°C as defined fever, the mean
temperature difference of clinical tympanic temperature measurement was
- 0.74°C (95% LOA, 1.75°C to 0.27°C), the sensitivity and specificity was
95% and 96% respectively. While, for home tympanic temperature
measurement, the mean temperature difference was - 0.14°C (95% LOA -
1.27°C, 0.98°C), sensitivity and specificity was 69%, and 85%
respectively. The authors concluded that home tympanic thermometer
could be used for screening but not to decide patient follow-up.29,level 2

Hay et al study compared between body temperature measured by

infrared tympanic thermometer and axilla temperature measure by
mercury in glass thermometer among 16 preschool children with acute
cough presenting to primary care. The mean differences between the
axillary and tympanic measures was 1.18°C (95% LOA - 0.73 to 3.09).
When used axilla temperature with cut of point of 37 C or greater, the
sensitivity and specificity were 15% and 98.6% respectively. The authors
concluded that the mean difference was too large for the evaluated
infrared tympanic thermometer to replace the axilla mercury in glass
thermometer in normal clinical practice and that infrared tympanic
thermometer was poorly in detecting febrile children.30, level 2

The above studies were summaries in table 2.

5.2.2 Infrared tympanic thermometer in adults

Moran et al conducted study among 110 patients admitted to intensive

care unit a tertiary referral, university affiliated hospital in Australia, with
the aim to compare body temperature measured by infrared tympanic
thermometer and axilla temperature using mercury in glass thermometer
to pulmonary artery catheter temperature measurement. They found that
pulmonary artery temperatures were more consistent with axilla mercury-
in-glass thermometer with the mean difference of 0.295 (95% LOA -
0.424°C to 1.014°C) than infrared tympanic thermometer with the mean
difference of 0.358°C (95% LOA -0.560°C to 1.276°C). They concluded
that infrared tympanic thermometer could not be used as accurate
measures of core body temperature in the critically ill.31, level 2

In another smaller study of 25 intensive care unit patients conducted by

Farnell et al comparing chemical and tympanic temperature
measurements against the „gold standard‟ Pulmonary Artery Catheter
(PAC). They found that the mean temperature differences between the
PAC were 0.2 °C(p<0.0001, SD = 0.34) for chemical and 0.0 °C (p=0.39,

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 SD = 0.59) for tympanic temperatures and the mean temperature
differences ranged from -1.3 to 0.9°C and -2.3 to1.0 °C respectively. Both
the chemical and tympanic thermometers were significantly correlated with
temperatures derived from the PAC (r = 0.81, p<0.0001 and r = 0.59,
p<0.0001). The Bland–Altman plot of difference suggests that 95% of the
chemical thermometer readings were within a -0.5 to0.9 C range of the
PAC. In contrast, 95% of the tympanic thermometer readings were within
a much wider range (-1.2 to 1.2 C).5, level 2

Rajee and Sultana compared temperature measure using infrared

tympanic thermometer with oral temperature measure using mercury in
glass thermometer among 200 emergency room attendees Freemasons
Hospital, East Melbourne, Victoria, Australia. They found the tympanic
thermometer agreed with the mercury thermometer within −1.0 to 1.1°C.).
When fever defined as a oral temperature of 38°C or greater, the
sensitivity and specificity of tympanic thermometer was 60% and 97%
respectively.32, level 2

However, in another study conducted in Hong Kong by Lo et al in 100

adult surgical patients compare between temperature measured using
infrared tympanic thermometer with oral temperature by mercury in glass
thermometer. They found greater agreement between tympanic and oral
temperatures measurement in afebrile patients, the mean difference was
0.018°C (95%LOA -0.52°C to 0.56°C) than febrile patients with the mean
difference of 0.24°C (95%LOA -0.43°C, 0.9°C). The authors concluded
that oral mercury-in-glass thermometer should not be replaced with
infrared tympanic thermometer.33, level 2

5.2.3 Non-Contact infrared forehead/skin thermometer in children

A prospective, analytical, cross-sectional study was designed by Teran et

al in order to assess the effectiveness of the infrared non-contact
thermometer and temporal artery thermometer with rectal mercury in glass
thermometer in 434 children aged 1 to 48 months in the emergency room
and inpatient unit from the Pediatric Hospital Albina R. de Patiño. They
found that both temperature measurements were strongly correlated with
the rectal temperature measurements r=0.950 for temporal artery
thermometer and r=0.952 for non-contact infrared thermometer. The mean
difference in temperature between the rectal mercury in glass
thermometer and the non-contact thermometer was 0.029 0.01°C
(p<0.001), while the mean difference between the temporal artery
thermometer and the rectal mercury in glass thermometer was - 0.20
0.27°C (p<0.001). When fever was defined as a temperature equal to or
higher than 38°C, the sensitivity and specificity for the non-contact
thermometer was 97%. While the sensitivity was 91% and specificity was

10
99.6% for temporal artery thermometer. The authors concluded that the
non-contact infrared thermometer is a reliable, comfortable and accurate
method of measurement of temperature and is a very useful tool to screen
for fever in the paediatric population.34, level 2

The above study was summaries in table 3.

Similarly, De Curtis et al evaluated accuracy temperature measured using

infrared skin thermometer compared to temperature measure using rectal
mercury in glass thermometer as reference test, in 107 newborn admitted
to the newborn nursery or neonatal intensive care unit at University of
Rome. They found that the mean difference temperature reading of non-
contact infrared thermometer taken immediately after the mercury in glass
rectal thermometer measurement was -0.052 C (95% CI, -0.112 to
0.008 C). The LOA was -0.682 to 0.578. The authors concluded that
infrared skin thermometer cannot act as a substitute for rectal mercury in
glass thermometer in all cases; however, the differences between the two
measurements were modest and this is encouraging for the use of infrared
skin thermometer in monitoring body temperature in newborns.12, level 2

However, another study done by Fortune et al evaluated the accuracy of a

non-contact infrared thermometer compared with a rectal electronic
thermometer in two hundred patients with the mean age of 1.4 years
presenting to a tertiary pediatric emergency department. The study result
revealed a linear relationship between rectal electronic and non-contact
infrared thermometer was observed; however, the coefficient of
determination value between the two measurement was r2=0.48 (p<0.01).
They also found that non-contact infrared thermometer tend to
overestimate the temperature of afebrile children and underestimate the
temperature in febrile patients with r2=0.149 (p<0.01). The author
concluded that on-contact infrared thermometer did not sufficiently agree
with rectal electronic thermometer to indicate its routine use.35, level 2

Chiappini et al conducted a study to assess the diagnostic accuracy of

non-contact infrared thermometer compared with axilla mercury in glass
thermometer for detecting fever in 251 children admitted to pediatric
emergency department or pediatric clinic in five Italian cities. They found
that the mean body temperature obtained by mercury-in-glass
thermometer and non-contact infrared thermometer was 37.18 C (SD
0.96 C) and 37.30 C (SD = 0.92 C), respectively (p=0.153). Non-contact
infrared thermometer clinical repeatability was 0.108 C (SD 0.095 C),
similar to that of the mercury-in-glass thermometer 0.11 C (SD 0.1 C;
p=0.517). A significant correlation between temperature values obtained
with the two procedures was observed (r2 =0.84; p<0.0001). The limits of
agreement, by the Bland and Altman method, were - 0.62 (95%CI: - 0.47
to - 0.67) and 0.76 (95%CI: 0.61 to 0.91). When fever defined as axillary

11
 temperature > 38 C; the sensitivity was 89 % and specificity was 90%
respectively. The Non Contact Infrared Thermometer showed a good
performance. 36, level 2

5.3 Cost effectiveness/Cost

Tympanic measurement can be provided by infrared sensing thermometer

only, so there was no comparative analysis by different types of
thermometer, thus only the least and most expensive type of infrared
sensing model. The cost analysis calculated on total cost of using
exclusively the least costly model and the most expensive model of
infrared sensing thermometer was conducted. The result showed that the
tympanic thermometer with the lowest purchase price has a higher overall
cost compare to the tympanic thermometer with highest purchase priced.
This is because of the increased cost of consumables (nearly double the
price) that contribute to the total cost. In contrast, the cost of covers is
lower in the most expensive model. The recurring costs per year
(consumables and staff) are more than £ 50,000 (RM 246,824.00) more
per year for the cheaper model, which outweighs the higher initial
purchase price of the most expensive model. The result also indicate that
time for reading is not important cost driver for tympanic measurement
because it take only two second to make a temperature reading. The
(discounted) cost over 10 years including staff costs is range from £ 732,
000 (RM 3,613,504.00) to £ 1,064,000 (RM 5,252,416.00).15 level 1

5.4 Limitations

Several imitation need to be address when interpreting the above studies,

there were lack of information regarding thermometer calibration,
temperature methods such as depth of penetration, placement time, mode
used or “ear tug use”, and whether measurement were concurrent or
sequential and the time to complete all measurement, lack of information
on blinding across temperature measurement sites and during repeated
measurement at the same site, small sample size i.e. less than 50 patient.
In additional, the selection was done by one reviewer. Although there was
no limit apply on language during the search but only English articles were
included in this report.

12
Table 1: Summary of studies reporting sensitivity and specificity of different type of
thermometer using bladder or rectal thermometer as reference test
Authors Study Test Methods Reference Fever Sen % Spec PPV NPV
design test cut off %
levels
Nimah CS Infrared tympanic indwelling RSP 38 C 80 81 81 79
20
et a. thermometer Foley Catheter
2006 with 400
forehead sensor Series 57 87 83 66
Touch temple thermistor
thermometer bladder
indwelling Mon a Thermometer 67 93 91 73
therm rectal
probe rectum
digital axilla 40 98 96 61
thermometer
Dodd SR Infrared tympanic Rectal 38 C 63.7 95.2 - -
21
et al. thermometer thermometer
2006 either
electronic,
indwelling or
mercury
El-Radhi CS Infrared tympanic Rectal 38 - 76 - - -
& Patel thermometer thermometer 38.9 C
6 24
(device not
Electronic stated) 38 C 100
2006 thermometer
89
Sehgal Case Infrared tympanic Digital rectal 38 C 100 76 78 100
23
et al. control thermometer thermometer
38.5 C 100 80 87 100
2003 39 C 100 85 72 100
39.5 C 100 89 71 100
van Cross Infrared tympanic digital rectal 38 C 93.3 92 87.5 95.8
Staaij et Sectional thermometer thermometer
24
al. 38.5 C 100 100 - -

2003
Jean- prospectiv Infrared tympanic Digital rectal 100.4 F 68.3 94.8 - -
Mary e thermometer thermometer
25
et al. observatio Infrared axilla 63.5 92.6
2002; nal thermometer

Paes, Prospectiv Infrared tympanic Digital rectal 38 C 80 97 91 94

26
et al. e study thermometer thermometer
Infrared skin 12 100 100 77
2010 thermometer (
Beurer)
Infrared skin 64 96 84 89
thermometer
(thermofocus)

SR: Systematic Review Sen : sensitivity Spec: specificity PPV: Positive

Predictive Value
NPV: Negative Predictive
Value

13
 Table 2: Summary of studies reporting sensitivity and specificity of infrared tympanic
thermometer using mercury in glass axilla thermometer as reference test

Authors Study Test Reference Fever Sen % Spec PPV NPV

design Methods test cut off %
levels
Devrim et Cross Clinical mercury-in- 38.3 C 95 96 - -
27
al. sectional infrared glass axilla
2007 tympanic thermometers
thermometer

home infrared 69 85
tympanic
thermometer

Hay et Cross Infrared mercury axilla ≥ 37 C 15 98.6 75 19

28
al. sectional tympanic thermometer
thermometer
2004

NPV: Negative Predictive Value Sen : sensitivity Spec: specificity PPV: Positive Predictive
Value

Table 3 : Summary sensitivity and specificity non-contact infrared thermometer and

temporal artery thermometer using rectal mercury in glass thermometer as reference test

Authors Study Test Methods Reference Fever Sen % Spec PPV NPV
design test cut off %
levels
Teran et Prospective Non contact Rectal 38 C 97 97 95.2 98.1
32
al. analytical infrared mercury in
2012 cross thermometer glass
sectional thermometer
Temporal artery 91 99.6 99.3 94.6
thermometer

6. CONCLUSION

6.1 Effectiveness/efficacy

6.1.1 Infrared tympanic thermometer in children

One systematic review and four diagnostic accuracy studies showed that
infrared tympanic thermometer temperature measurement better reflect
the core body temperature than axilla thermometer temperature
measurement. It also showed that the Infrared tympanic thermometer
sensitivity and specificity was moderate. However, the sensitivity and
specificity increased with higher cut of point of temperature defined as
fever.

6.1.2 Infrared tympanic thermometer in adult

With respect to its use in adult population, there was fair level of evidence
involving four diagnostic accuracy studies that showed that infrared

14
 tympanic thermometer was less accurate to reflect core body temperature
than pulmonary artery catheter or mercury in glass oral thermometer.

6.1.2 Non- contact infrared thermometer

Four studies were retrieved on the effectiveness non-contact infrared

thermometer in children. The evidence found was inconclusive whereby
two studies reported good correlation of non- contact infrared thermometer
with rectal/axilla mercury in glass but the other two studies did not show
good correlation

6.2 Cost - effectiveness/Cost

The evidence showed that the infrared tympanic thermometer with lowest
purchase price has higher overall cost compared to the highest purchase
price, This was because of the increased cost of consumables (nearly
double the price in the cheaper infrared tympanic thermometer) that
contributed to the total cost. In contrast, the cost of covers of the
expensive infrared tympanic thermometer was found to be cheaper.

6.3 Safety

There was no retrievable evidence reporting any adverse events related to

the use of the infrared thermometer.

15
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17
9. APPENDIX
9.1. Appendix 1: LITERATURE SEARCH STRATEGY

Ovid MEDLINE® In-process & other Non-Indexed citations and

OvidMEDLINE® 1948 to present
1. Fever/
2. fever*.tw.
3. hyperthermia*.tw.
4. pyrexia*.tw.
5. 1 or 2 or 3 or 4
6. Thermometers/
7. Thermometer*.tw.
8. Body Temperature/
9. (body adj1 temperature*).tw.
10. Thermography/
11. thermograph*.tw.
12. 6 or 7 or 8 or 9 or 10 or 11
13. 5 and 12

OTHER DATABASES
EBM Reviews - Cochrane
database of systematic
reviews
EBM Reviews - Health Same MeSH, keywords, limits used as per
Technology Assessment MEDLINE search
PubMed
NHS economic
evaluation database
FDA
MHRA
TUV
Euroscan
Australia and New Non contact infrared thermometer
Zealand Horizon
Scanning Network
(ANZHSN)
NHSC

18
9.3 Appendix 2

HIERARCHY OF EVIDENCE FOR TEST ACCURACY STUDIES

Level Description
1. A blind comparison with reference standard among an appropriate
sample of consecutive patients
2. Any one of the following Narrow population spectrum
3. Any two of the following Differential use of reference
4. Any three or more of the following standard
Reference standard not blind
Case control study
5 Expert opinion with no explicit critical appraisal, based on
physiology, bench research or first principles.

SOURCE: NHS Centre for Reviews and Dissemination (CRD) University

of York, Report Number 4 (2nd Edition)

19