Journal of Tropical Pediatrics, 2020, 00, 1–10

doi: 10.1093/tropej/fmaa111
Original Paper

Point-of-Care Testing Using Invasive and Non-

Invasive Hemoglobinometers: Reliable and
Valid Method for Estimation of Hemoglobin

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among Children 6–59 Months
Gomathi Ramaswamy MD, MBBS, Kashish Vohra MSc, BSc, Kapil
Yadav MD, MBBS, Ravneet Kaur MD, MBBS, Tripti Rai MSc, BSc,
Abhishek Jaiswal, MD, MBBS, and Shashi Kant, MAE, MBA, DNB,
MD, MBBS
Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi 110029, India
Correspondence: Kapil Yadav, Centre for Community Medicine, All India Institute of Medical Sciences, Room No 37,
New Delhi, India. Tel: 011-265-93848. E-mail: <dr.kapilyadav@gmail.com>.

ABSTRACT

Introduction: Globally around 47.4% of children and in India, 58% of children aged 6–59 months
are anemic. Diagnosis of anemia in children using accurate technologies and providing adequate
treatment is essential to reduce the burden of anemia. Point-of-care testing (POCT) devices is a po-
tential option for estimation of hemoglobin in peripheral and field settings were the hematology ana-
lyzer and laboratory services are not available.
Objectives: To access the validity of the POCTs (invasive and non-invasive devices) for estimation
of hemoglobin among children aged 6–59 months compared with hematology analyzer.
Methods: The study participants were enrolled from the pediatric outpatient department in
Haryana, India, from November 2019 to January 2020. Hemoglobin levels of the study participants
were estimated in Sahli’s hemoglobinometer and invasive digital hemoglobinometers (DHs) using
capillary blood samples. Hemoglobin levels in non-invasive DH were assessed from the finger/toe
of the children. Hemoglobin levels measured in POCTs were compared against the venous blood
hemoglobin estimated in the hematology analyzer.
Results: A total of 120 children were enrolled. The mean (SD) of hemoglobin (g/dl) estimated in
auto-analyzer was 9.4 (1.8), Sahli’s hemoglobinometer was 9.2 (1.9), invasive DH was 9.7 (1.9), and
non-invasive DH was 11.9 (1.5). Sahli’s hemoglobinometer (95.5%) and invasive DH (92.2%) had
high sensitivity for the diagnosis of anemia compared with non-invasive DH (24.4%). In contrast,
non-invasive DH had higher specificity (96.7%) compared with invasive DH (83.3%) and Sahli’s
hemoglobinometer (70%). Invasive DH took the least time (2–3 min) for estimation of hemoglobin
per participant, followed by Sahli’s (4–5 min) and non-invasive DH (5–7 min).
Conclusion: All three POCT devices used in this study are reasonable and feasible for estimating
hemoglobin in under-5 children. Invasive DHs are potential POCT devices for diagnosis of anemia

C The Author(s) [2020]. Published by Oxford University Press. All rights reserved.
V
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2  Validation of Hemoglobinometers

among under-5 children, while Sahli’s can be considered as a possible option, where trained and
skilled technicians are available. Further research and development are required in non-invasive DH
to improve accuracy.

LAY SUMMARY
In India, anemia is a serious public health problem, where 58% of the children aged 6–59 months

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are anemic. Point-of-care testing (POCT) using digital hemoglobinometers (DHs) has been recom-
mended as one of the key interventions by the Anemia Mukt Bharat program since 2018 in India.
These POCT devices are easy to use, less invasive, can be carried to field, require minimal training
and results are available immediately. Therefore this study assessed the validity of POCT devices—
invasive DH, non-invasive DH and Sahli’s hemoglobinometer among 6–59 months children in facil-
ity setting compared with the gold standard hematology analyzer. A total of 120 children under 6–
59 months of age were enrolled from the pediatric outpatient department in Haryana, India, from
November 2019 to January 2020. The (mean hemoglobin in g/dl) invasive (9.7) and non-invasive
DH (11.9) overestimated hemoglobin value, while Sahli’s (9.2) underestimated hemoglobin com-
pared with hematology analyzer (9.4). Invasive DH (92.2%) and Sahli’s hemoglobinometer (95.5%)
reported high ability to correctly identify those with anemia compared with non-invasive DH
(24.4%). In contrast, non-invasive DH (96.73%) had higher ability to correctly identify those with-
out the anemia compared with invasive DH (83.3%) and Sahli’s (70%).

INTRODUCTION hospital are few of the challenges associated with this

Children are one of the most vulnerable groups for
anemia. Globally, 47.4% of children under 5 years of
age are anemic [1]. In India, where anemia is a ser-
ious public health problem, around 6.8 crores (58%)
of children aged 6–59 months are anemic [2].
Childhood anemia impairs cognitive, motor, and lan-
guage development, and academic achievement. It
also increases the risk of infection, overall morbidity,
and mortality [3–5]. In the long run, anemia under-
mines work productivity in adulthood with substan-
tial economic consequences to the individual as well
as the country [4, 5]. Given the detrimental long-
term effects, prevention in early childhood is crucial.
Prophylactic iron–folic acid supplementation,
deworming, food-based approaches like dietary di-
versity, food fortification, and behavior change com-
munication interventions are implemented by the
governments to address anemia.
Hemoglobin is the most commonly used param-
eter for the diagnosis of anemia. The standard
method for hemoglobin estimation is using a hema-
tology analyzer in clinical laboratories [6]. However,
the prerequisite of venipuncture, clinical laboratory,
trained laboratory technicians, the requirement of at
least 1-ml blood and more than one visit to the
method. Venous puncture itself is a stressful proced-
ure among the children, parents, and the healthcare
worker. A study conducted in Brazil reported that a
failure rate of 10% was observed in the peripheral
venous sampling, and it was higher among malnour-
ished children [7]. Hence, alternate less invasive or
non-invasive technique is imperative for hemoglobin
estimation among under-5 children.
POCT for hemoglobin is recently becoming a
popular strategy to overcome the challenges associ-
ated with laboratory-based investigations. POCT
devices are easy to use, less invasive, can be carried
to the field, requires minimal training, and results are
available immediately. The commonly available
POCT methods for detection of anemia are Sahli’s
method, World Health Organization’s Hemoglobin
Color Scale, invasive digital hemoglobinometers
(DHs) using reagent-containing microcuvettes
(HemoCue 201, TrueHb), newer invasive DH using
reagent-free microcuvettes (HemoCue 301,
DiaSpect), non-invasive DH such as multiwavelength
co-oximetry [Radical-7(TM) and Pronto-7(TM)];
Masimo Corp. All invasive POCT requires less than
one drop of blood and a capillary blood sample can
be used to estimate hemoglobin.

Sahli’s hemoglobinometer is a widely used POCT
for more than two decades globally [8]. It is relative-
ly inexpensive, simple to use with no higher recur-
ring costs for testing materials and electricity, and
requires only a small amount of blood taken by a
skilled technician [9, 10]. The invasive DH is being
used in health camps, blood donation camps, nation-
al surveys, and field-level testing. The invasive DH
has reported acceptable diagnostic accuracy, and
Sahli’s reported a diverse range of diagnostic accur-
acy [11–13]. However, these studies have majorly
conducted among adolescents and adult age group.
Under-5 children are a challenging group for obtain-
ing the capillary sample, and studies have reported a
significant change in the diagnostic accuracy of
hemoglobin due to variation in the execution of ca-
pillary blood sampling procedure [14, 15].
The newer non-invasive DH can be a potential
option for estimating hemoglobin since these is no
pain associated with this procedure. It may be more
acceptable among the children and parents and con-
venient for the healthcare workers. However, there
are limited studies published on the validity of both
invasive and non-invasive DH for the estimation of
hemoglobin among the under-5 age group. Thus,
this study was aimed to assess the validity of POCT
devices Sahli’s hemoglobinometer, invasive DH, and
non-invasive DH among 6–59 months children in fa-
cility setting compared with the gold standard hema-
tology analyzer.
METHODOLOGY
Study design and setting
The present validation study was conducted from
November 2019 to January 2020 at the Sub District
Hospital (SDH), Comprehensive Rural Health
Services Project, Ballabgarh in Haryana, India.
Participants and ethics approval
A total of 120 children from 6 to 59 months of age
attending pediatric outpatient department clinics at
SDH Ballabgarh, Haryana, were enrolled in the
study. Children with minor ailments such as cough
or fever for <1-week, acute otitis media, mild impe-
tigo, viral warts, tenia versicolor etc., were included.
We excluded children with a history of renal, cardiac,
Validation of Hemoglobinometers  3
and respiratory diseases, children with any illness for
more than 2 weeks, and severely ill children assessed
by the investigator.
Ethics approval was obtained from the AIIMS
Institute Ethics Committee. Written informed con-
sent was obtained from Mother/Guardian.
Description of devices
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Hematology analyzer (Sysmex XS 1000i, Kobe,
Japan)
This autoanalyzer was selected as the reference test.
It uses Sodium Lauryl Sulfate method, which is a
non-cyanide method using an automated blood cell
counter machine for hemoglobin estimation, and its
principle is similar to the gold standard, i.e. cyanme-
themoglobin method.
Sahli’s hemoglobinometer
The principle in Sahli’s method involves the conver-
sion of hemoglobin to acid hematin and comparing
visually the color developed with that of standard
tinted glass. This method requires 20 ml of blood,
and results can be read by diffused daylight, 3 min
after adding the blood sample to hydrochloric acid.
It does not run on electricity nor requires cuvettes or
strips for every patient; thus, it is relatively
inexpensive.
HemoCue Hb 301 System (HemoCue AB,
Ängelholm, Sweden)
It is a pre-calibrated, portable, battery-operated, re-
agent-free microcuvette device that estimates hemo-
globin by measuring the absorbance of whole blood
at the Hb/HbO2 isosbestic points at the wavelength
of 506 and 880 nm for compensation of turbidity. It
requires 10 ml amount of blood, and provides results
within 3 s. It can operate in temperature ranging
from 10 to 40 C and measures hemoglobin from 0
to 25.6 g/dl.
Rad 67 Spot check pulse co oximeter (Rad-67TM
R R R
Pulse CO-OximeterV and rainbowV DCIV-mini
Sensor, Masimo, USA)
It measures SpO2, total hemoglobin- SpHb, and
SpCO with the easy-to-use finger gauge for patients
 3 kg. The sensor collects the patient’s vital signs
4  Validation of Hemoglobinometers
and sends them to the device, which, in turn, displays
the calculated SpHb value in g/dl. It displays results
within 30 s as claimed by the manufacturing com-
pany and weighs around 0.37 kg. The total hemoglo-
bin (SpHb) accuracy range of the device is 8–17 g/
dl. The device has three parameters viz. perfusion
index, signal quality, and interference to indicate the
quality of the test while measuring hemoglobin.
Accurate results will be obtained when all three
parameters fall in the green zone indicating stable
condition (Fig. 1).
Sample size and sampling method
All children who attended the pediatric clinic at the
SDH, Haryana, during the study period, and pre-
scribed for any blood investigation by pediatricians
were included. Considering bias (SD of difference)
as 0.1 (1.1) g/dl alpha error of 5%, power 80%, and
maximum allowed difference 2.8 g/dl in hemoglobin,
the minimum required sample size was 105 [16, 17].
The sample size of 120 children was finalized, con-
sidering a 10% non-response rate.
Data collection
A standard protocol was followed for performing all
the tests. As non-invasive DH involves prick free
method, it was used first for testing of hemoglobin
to keep the child calm for further invasive proce-
dures. Non-invasive DH displays spot-check results
correctly when its signal quality indicators for mo-
tion, perfusion index quality, and ambient light inter-
ference are stable. Each child was sampled at sitting
position, with the non-invasive DH positioned on a
flat surface at the level of the child’s hand. The finger
gauge, which measures the size of the finger or
Fig. 1. Non-invasive DH displaying hemoglobin value,
signal quality indicators and SpO2 values.
thumb or great toe was used to select the appropriate
finger or toe for measuring hemoglobin. The ring
sensor model was used on the selected finger or toe,
and the reading was obtained according to the manu-
facturer instructions (as shown in Fig. 2). The probe
was covered by a black sheet (provided by the manu-
facturer) to avoid light interference. Various cartoon
characters were showed to calm the child while test-
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ing using non-invasive DH.
Under strict aseptic precautions, the second drop
of capillary blood was used for Sahli’s, and the third
drop was used for invasive DH for estimation of
hemoglobin. The sequence of the blood sample
taken was alternated between Sahli’s and invasive
DH to overcome any bias that may arise due to the
difference in the second and third drop of blood.
Similarly, 2 ml of venous blood drawn from antecu-
bital fossa was used for hemoglobin estimation in a
hematology analyzer. The blood samples for all tests
were collected in the same setting on the same day,
and there was no treatment administered in
between.
Quality assurance
Hemoglobin values displayed from Sahli’s hemoglo-
binometer, invasive DH, and non-invasive DH were
not disclosed among technicians to avoid inter-
observer bias, especially with Sahli’s. Internal quality
control (IQC) was run daily for invasive DH and
Fig. 2. Estimation of hemoglobin using non-invasive
digital hemoglobinometer.

hematology analyzer. All three levels of IQC samples
(normal, low, and high) were checked and plotted in
the Levy Jennings (LJ) plot. All values were found to
be within the two standard deviation range in the LJ
plot. The end-user for non-invasive DH requires no
calibration. The non-invasive DH sensor uses a valid-
ation process different from the conventional quality
control materials of the automated hematology ana-
lyzer and the control cuvette of the HemoCue [18].
Data management and analysis
The data were entered in an android based mobile
application tool Epicollect5 and exported to Stata 14
software (Stata Corp. 2015, College Station, TX:
Stata Corp LP) for data analysis. The mean differ-
ence (SD of difference) and limits of agreement
(LOA) were calculated based on the Bland Atman
plot. Lin’s concordance coefficient and intra class
correlation coefficient were calculated with 95% CI.
Weighted Kappa was calculated to assess the agree-
ment between the equipment on grades of anemia.
Diagnostic accuracy for each test was examined
based on sensitivity, specificity, positive and negative
predictive values and ROC curve to detect anemia. A
p-value of <0.05 was considered for ascertaining
statistical significance.
RESULTS
In total, 120 children aged 6–59 months were
included in this study. Of the total, 77 (64.2%) were
male and 43 (35.8%) were female children. The
mean age of the children was 33.7 6 15.7 months,
ranging from 6 to 59 months. The overall prevalence
of anemia was 75.0% (n ¼ 90) estimated using hema-
tology analyzer [mild anemia ¼ 18.3% (n ¼ 22);
moderate anemia ¼ 48.3%, (n ¼ 58); and severe
Table 1. Prevalence of anemia and mean (SD) of hemoglobin determined by hematology analyzer,
Device Sahli’s, invasive DH and non-invasive DH among 6–59 months children in India (n ¼ 120)
Hemoglobin concentration, g/dl Hematology analyzer
Mean 6 SD 9.4 6 1.8
Range 4.0–13.6
Prevalence of anemia, n (%) 90 (75)
*p < 0.001;
**p > 0.05.
Validation of Hemoglobinometers  5
anemia ¼ 8.3% (n ¼ 10)]. Prevalence of anemia
using Sahli’s was 79.1% (n ¼ 95), invasive DH was
73.3% (n ¼ 88) and non-invasive DH was 19.2%
(n ¼ 23). (Table 1 and Fig. 3) There was no signifi-
cant difference in the prevalence of anemia between
invasive DH (p ¼ 0.768) and Sahli’s (p ¼ 0.442)
compared with hematology analyzer. There was a
significant difference in prevalence of anemia in esti-
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mated in non-invasive DH (p < 0.001) compared
with hematology analyzer.
Bland Altman analysis
The mean (SD) of hemoglobin (g/dl) values esti-
mated in hematology analyzer was 9.4 (1.8) vs. mean
(SD) observed in Sahli’s was 9.2 (1.9), p < 0.001, in-
vasive DH was 9.7 (1.9), p < 0.001 and non-invasive
DH was 11.9 (1.5), p < 0.001. When compared with
the hematology analyzer, bias and LOA for Sahli’s
was 0.27 g/dl (2.0 to 1.4), invasive DH was
0.27 g/dl (1.4 to 1.9), and non-invasive DH was
2.49 g/dl (0.3 to 5.2; Fig. 4 and Table 2).
Lin’s concordance and agreement between DHs
and hematology analyzer
Lin’s concordance coefficient for non-invasive DH
was 0.3 (p < 0.001), invasive DH was 0.9
(p < 0.001) and Sahli’s was 0.9 (p < 0.001) com-
pared with hematology analyzer for estimation of
hemoglobin. The weighted Cohen’s Kappa coeffi-
cient for different grades (no/mild/moderate/se-
vere) of anemia for Sahli’s was 0.70, invasive DH
was 0.73, and non-invasive DH was 0.12, indicating a
good degree of agreement for invasive DH and
Sahli’s compared with hematology analyzer.
Device Sahli’s Invasive DH Device non-invasive DH
9.2 6 1.9* 9.7 6 1.9* 11.9 6 1.5*
3.5–12.6 4.4–13.5 5.1–15.2
95 (79.1)** 88 (73.3)** 23 (19.2)*
6  Validation of Hemoglobinometers

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Fig. 3. Prevalence of anemia by severity (%) determined from the non-invasive DH, invasive DH, Device Sahli’s and
hematology analyzer among 6–59 months children in India (n ¼ 120).

Fig. 4. Bland–Altman plot showing agreement in hemoglobin concentration assessed by hematology analyzer, Sahli’s
hemoglobinometer, invasive DH and non-invasive DH.

Table 2. Bias (SD) of difference, LOA and concordance determined by hematology analyzer,
Device Sahli’s, invasive DH and non-invasive DH among 6 to 59 months children in India
(N ¼ 120)
Sahli’s hemoglobinometer Invasive DH Non-invasive
(n ¼ 120) (n ¼ 120) DH (n ¼ 120)

Bias (SD) of difference in hemoglobin 0.27 6 1.9 0.27 6 1.9 2.49 6 0.1
95% LOA in hemoglobin 2.0, 1.4 1.4, 1.9 0.3, 5.2
Sensitivity (%) for detecting anemia 95.5 92.2 24.4
Specificity (%) for detecting anemia 70 83.3 96.7
Positive predicted value (%) for detecting anemia 79.2 73.3 19.2
Negative predicted value (%) for detecting anemia 20.8 26.7 80.8
Lin’s concordance correlation coefficient (qc) 0.9 0.9 0.3
Cohen’s Kappa coefficient 0.70 0.73 0.12

Fig. 5. ROC of hemoglobin values measured using
hemoglobinometers compared with hematology analyzers.
The area under the curve for Sahli’s was 0.90, in-
vasive DH was 0.94 and non-invasive DH was 0.78
(p < 0.001) and depicted in Fig. 5.
Sensitivity and specificity for detecting anemia
Device Sahli’s had 95.5% sensitivity, 70% specificity,
79.2% positive predictive value, and 20.8% negative
predictive value. For invasive DH, the sensitivity,
specificity, positive predictive value and negative pre-
dictive value was 92.2%, 83.3%, 73.3% and 26.7% re-
spectively and for device non-invasive DH its
sensitivity, specificity, positive predictive value and
negative predictive value was 24.4%, 96.7%, 19.2%
and 80.8%, respectively for detection of anemia as
compared with the hematology analyzer.
Sahli’s device had a sensitivity of 100% and speci-
ficity of 90.8% to detect severe anemia (hemoglobin
< 7 g/dl) compared with auto-analyzer. Invasive DH
had sensitivity of 90% and specificity of 90.8% and
non-invasive DH had sensitivity of 10% and specifi-
city of 100% to detect severe anemia.
Non-invasive DH’s performance or it’s sensitivity
and specificity is dependent on signal quality indica-
tors such as motion, perfusion index quality, and am-
bient light interference. If all these indicators are
stable, then quick results with better diagnostic ac-
curacy can be achieved. Supplementary Table S1
depicts how all these indicators combined or indi-
vidually affects the sensitivity and specificity of the
device. Sensitivity of the device improves when indi-
cator for motion was in green zone (when child is
Validation of Hemoglobinometers  7
not moving during the procedure) whereas other
indicators such as perfusion index quality and ambi-
ent light interference did not affect the sensitivity of
the device. Specificity of the device was above 95%
only when all three indicators or even any of them
were in green zone. When the indicator for motion
alone, or motion with perfusion index quality, or all
three indicators were in green zone, device showed
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100% specificity.
Invasive DH required 2–3 min to complete whole
procure for estimation of hemoglobin, whereas
Sahli’s took 4–5 min and non-invasive DH took 5–
7 min per participant for estimation of hemoglobin.
DISCUSSION
This study assessed the diagnostic accuracy of three
POCT hemoglobinometers compared with the
hematology analyzer to estimate hemoglobin among
children from 6 to 59 months of age. The mean dif-
ference (LOA) in the hemoglobin values of the
hematology analyzer compared with Sahli’s was
0.3 g/dl (2.0 to 1.4), invasive DH was 0.3 g/dl
(1.4 to 1.9), and non-invasive DH was 2.5 g/dl
(0.3 to 5.2). Both invasive DH and Sahli showed
similar excellent concordance, whereas non-invasive
DH showed poor concordance with hematology ana-
lyzer. The present study reported high sensitivity of
Sahli’s (95.5%) and invasive DH (92.2%) compared
with the gold standard hematology analyzer for
detecting anemia, exhibiting good validity between
the two methods. In contrast, non-invasive DH
(24.4%) had reported poor sensitivity with but with
higher specificity (96.73%) compared with other
POCTs.
A study carried out among school-going children
(6–8 years) stated higher sensitivity and specificity
for similar invasive DH (HemoCue 201) compared
with the hematology analyzer for detecting anemia
[12]. Studies reported that sensitivity and specificity
of invasive DH varies with the type of blood sample
(venous or capillary) used for estimation of hemo-
globin [18–24]. Another study conducted in Mexico
among 1–5 years children; and other studies con-
ducted in California and India among adult patients
and healthy volunteers reported that non-invasive
device under reports hemoglobin values. In contrast,
8  Validation of Hemoglobinometers
the current study reported overestimated hemoglo-
bin values [25–27].
Several factors affect the accuracy of hemoglobin-
ometers. Geographical variations (altitude and tem-
perature), procedural differences in capillary blood
sample collection (Intra- and inter-observer varia-
tions), study participants related factors (age groups,
sex and biological determinants including Fahraeus
effect [11, 12, 18] lower hematocrit in capillary
blood vessels compared with venous vessels) might
be the reasons for the observed deviations in the
hemoglobin measurement. Non-invasive DH dis-
plays spot-check results correctly only when it’s sig-
nal quality indicators are stable. Figure 1 shows the
error when indicators are not stable. Due to this
characteristic, amongst children with continuous
body movement, it was difficult to obtain stable indi-
cators (all three indicators in green zone).
All three devices had certain advantages and dis-
advantages to be used in a facility setting. Invasive
DH was quick in displaying results and was easy to
handle. Sahli’s requires a trained technician.
However, it has an advantage of low cost without no
expensive recurrent logistics is involved, and it can
be considered as an alternative POCT when a skilled
technician is available. Non-invasive DH was a pain-
less procedure and favorable for children. However,
the issues with signal quality indicators among chil-
dren have to be dealt to obtain accurate results.
Invasive devices show overall better performance
than the non-invasive device in healthcare settings.
However, non-invasive hemoglobin measurement
could be significantly advantages as it avoids pricking
and can be executed as a pain-free procedure which
is favorable especially among children. Non-invasive
DH also has an added advantage as there is no risk
of exposure to bloodborne infections or discomforts
associated with invasive procedure. It is also environ-
ment friendly as it does not produce biomedical
waste for every patient test.
Non-invasive DH also has inbuilt storage capacity,
gives an option for error rectification, and also check-
ing previous visit hemoglobin at small healthcare
centers with minimal patient load ensuring follow-
up. This feature of non-invasive devices provides us
an opportunity to incorporate artificial intelligence
techniques and health management information
system for the diagnosis and management of anemia.
Few invasive devices also have a data storage facility.
However, only hemoglobin values and in a few, date
and time are stored.
The approximate device cost for Sahli’s was 13
USD, invasive DH was 286 USD and non-invasive
DH was 1770 USD. The approximate operating cost
per test is 0.20 USD for Sahli’s hemoglobinometer,
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0.41 USD for invasive DH and 0.68 USD for invasive
DH (for 1000 test package). The operating cost of
non-invasive DH is based on the number of tests
included in the package. Higher the number of tests,
lower the operating cost. A study conducted by
Ahankari et al. [9], reported similar cost for the
POCT devices for hemoglobin estimation. Though
the operating cost of non-invasive DH is relatively
high, the intangible costs associated with invasive
DH such as handling of biomedical waste, pain and
discomfort associated with the procedure for the
patients are avoided in non-invasive DH.
Certain limitations were associated with the
study. The study was conducted in the winter season
and temperature can affect the findings of hemoglo-
binometers, primarily non-invasive DH. Second, we
have conducted this study among the children who
were attending healthcare centers for management
of minor health ailments. Since these results are
derived from children attending health care centers
thus these results should be cautiously used with
general population having low prevalence of anemia.
We have purposefully selected this group to avoid
any unwarranted invasive procedures among the
under-5 children. However, the results have to The
cost of the devices was based on quotations from the
manufacturers. We have not conducted any cost-
analysis.
One strength of the study is adherence to the
quality control process for both the hematology ana-
lyzer and DHs throughout the study. To our know-
ledge, this is the first study from India to assess the
validity of non-invasive DHs among under-5 chil-
dren. Last, a comparison of various hemoglobinome-
ters aids the policymakers and programmers to
identify the best possible devices for the estimation
of hemoglobin. In India, POCT using DHs has been
recommended as one of the key interventions by the
Anemia Mukt Bharat program since 2018.

CONCLUSION
Accurate diagnosis of using point of testing devices
is essential for ensuring the quality of the anemia
control program. The validity of both invasive, non-
invasive, non-digital hemoglobinometers was
explored in this study. All three POCT devices were
found to be potential to use for estimation of hemo-
globin in under-5 children. Invasive DHs have high
diagnostic accuracy compared with other devices.
Sahli’s hemoglobinometer can be considered as a po-
tential alternative when trained technicians are avail-
able. Non-invasive DHs may require further research
in improving the diagnostic accuracy for the estima-
tion of hemoglobin.
SUPPLEMENTARY DATA
Supplementary data are available at Journal of
Tropical Pediatrics online.
ACKNOWLEDGEMENTS
We would like to thank Dr Neelesh Kapoor and Masimo US
Team for providing the non-invasive digital hemoglobinome-
ter ‘Rad 67 Spot check pulse co oximeter’. We also thank Dr
Pawan Gupta and HemoCue Team for providing ‘HemoCue
Hb 301’ device.
FUNDING
The work was not supported by Masimo or HemoCue.
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