Assessing hemoglobinometers for

maternal care: landscape analysis

of commercial products and late-

stage prototypes for anemia

screening

August 2018

i

Mailing Address

PO Box 900922

Seattle, WA 98109 USA

Street Address

2201 Westlake Avenue

Suite 200

Seattle, WA 98121 USA

www.path.org

ii

Contents

LANDSCAPE ANALYSIS ............................................................................................................................. 1

Clinical signs and symptoms ......................................................................................................................... 1

Manual visual comparison ............................................................................................................................. 1

Hemoglobin color scales ..................................................................................................................... 1

Sahli’s method ..................................................................................................................................... 2

Manual microhematocrit readers ......................................................................................................... 2

Portable hemoglobinometers ........................................................................................................................ 3

Noninvasive approaches ............................................................................................................................... 3

Pronto® and Radical® Devices ............................................................................................................. 4

NBM-200 ............................................................................................................................................. 4

Haemospect® ....................................................................................................................................... 4

HemaApp............................................................................................................................................. 4

ToucHb ................................................................................................................................................ 4

REFERENCES ............................................................................................................................................ 17

1

Landscape analysis

There are a number of options available for anemia screening at the point of care. These include clinical

examination of signs and symptoms, approaches that utilize manual visual comparison of blood samples,

portable hemoglobinometers, and noninvasive approaches. Each is described below, and a subset are

compared against key minimum target product profile (TPP) criteria in table 1.

Clinical signs and symptoms

Clinical examination assessing pallor (lightness in appearance) of the conjunctiva, tongue, nailbeds, and

palm is a useful strategy for ruling out severe anemia, and to a lesser extent for diagnosing severe

anemia.1,2 It is important to recognize that pallor is by no means a highly accurate clinical sign of anemia,3

but using this method can be beneficial in resource-constrained settings where severe anemia is common

and hemoglobin or hematocrit cannot be determined quantitatively.4 However, while specificity is high, the

low sensitivity of this approach makes it problematic because many severely anemic patients will go

undetected. The effectiveness of pallor in assessing anemia is influenced by a number of factors,

including which anatomical site is assessed; individual characteristics, such as skin pigmentation,

jaundice, or preexisting conjunctivitis; patient hemoglobin levels; and which hemoglobin cutoff values are

used.3 One approach to maximize sensitivity is to examine several anatomical sites and consider pallor

at any one of them to be a sign of anemia.5,6 This approach is supported by the fact that clinical

assessment of pallor has no associated cost and sensitivity is the limiting factor in performance.4 Due to

its widespread implementation and feasibility, clinical examination of pallor will likely remain a useful way

to assess severe anemia within the context of field work. However, more robust methods and

technologies are needed because the shortcomings of using pallor to detect anemia, particularly cases of

mild anemia, are well established and clinically relevant. Of note, clinical symptoms of anemia include

fatigue and shortness of breath; however, these are not sensitive enough to allow for diagnosis.

Manual visual comparison

A summary table of hemoglobin estimation approaches that utilize manual visual assessment of blood

samples can be found in table 2. These include hemoglobin color scales, Sahli’s method, and

microhematocrit readers.

Hemoglobin color scales

In 1995, the World Health Organization (WHO) developed the Hemoglobin Color Scale (HCS) for use in

settings where laboratory-based hemoglobin estimation methods are unavailable. The HCS is designed

for use in resource-limited settings where anemia would otherwise be diagnosed based on clinical signs

as outlined above.7 According to this method, a drop of blood is placed onto a test strip of specialized

chromatography paper. After 30 seconds has passed, the color of the paper is visually compared to a

standardized color scale on a card that depicts varying shades of red, corresponding to different

concentrations of hemoglobin. The first WHO HCS became commercially available in 2001, manufactured

by Copack (Oststeinbek, Germany).7 The Copack test uses a six-shade reference scale that includes

shades of red that correspond to 40-g/L, 60-g/L, 80-g/L, 100-g/L, 120-g/L, and 140-g/L measurements.8 In

addition to the HCS manufactured by Copack, other versions of the scale have also been developed. For

2

example, the HCS-HLL (Hindustan Lifecare Limited, India) has been adapted specifically for use in the

Indian context.9

According to a recent systematic review by Marn & Critchley (2016),10 the HCS can improve the accuracy

of anemia diagnosis when compared to clinical assessment alone.i The HCS is simple, inexpensive, does

not require electricity, and requires minimal training. However, it is subject to bias in visual color

comparison, requires the use of specialized chromatography paper, and is unable to detect changes in

hemoglobin smaller than 10 g/L.11 Additionally, a number of errors can also result from incorrect use of

the device. These include reading the scale under inadequate lighting, holding the scale at an incorrect

angle, applying too little or too much blood to the test strip, and reading the results too soon (before 30

seconds has passed) or too late (after two minutes has passed).12

Sahli’s method

Another technique for hemoglobin estimation that relies on visual color comparison is Sahli’s method,

currently recommended by the Government of India.13 The principle of Sahli’s method involves the

conversion of hemoglobin to acid hematin, which is then visually compared against the color of a solid

glass standard.14 To perform the test, dilute hydrochloric acid (HCl) is added to a graduated cylinder that

contains a 20µL blood sample. HCl is added until the color of the solution matches that of the glass

standard, as determined by a visual comparison to be conducted in a room with natural light. Once a

color match is determined, the level of fluid in the tube indicates the hemoglobin value. The test takes

approximately ten minutes and requires several supplies, including a Sahli hemoglobinometer, a pipette,

a stirring rod, dilute 0.1 M HCl, a dropper, and detergent.14 Although Sahli’s method is simple and

inexpensive and does not require electricity, it has a number of limitations. Notably, as with the HCS,

Sahli’s method is subject to bias due to the subjectivity involved with visual color comparison.

Additionally, the accuracy of the test relies upon accurate pipetting and the equipment being cleaned

properly between uses, and the materials are prone to wear and breakage. For example, the color of the

glass standard can fade over time, particularly when exposed to sunlight. 15,16

Manual microhematocrit readers

Hematocrit, or the ratio of red-cell volume to whole-blood volume, can also be determined using manual

approaches. According to this method, a capillary sample is collected, placed into capillary tubes with an

anticoagulant, and spun in a centrifuge until the sample separates. The tubes are then measured for the

height of the sample and that of the packed red-cell layer using a manual microhematocrit reader with a

reference chart.17 The height of the red-cell layer is divided by the total sample height to obtain the

percentage of red blood cells.14 Although this approach is inexpensive and simple, limitations include the

need for a centrifuge, as well as the bias introduced by visual assessment of the sample against the

manual reader scale.18 The results can also be influenced by the equipment, including the diameter of the

tube, the type of anticoagulant solution, and the type of centrifugation equipment.19 Automated

centrifuges that provide a digital reading, such as the HemataStat II (EKF Diagnostics, Cardiff, United

Kingdom), have also been developed.20

i Note: Many different method comparison studies have compared the performance of different anemia screening devices and approaches. However,

findings of method-comparison studies are often inconsistent, and studies can be hard to compare as different reference methods are often used.

Other factors, such as protocols, quality control, type of blood (capillary vs. venous), populations, blood collection methods/techniques,

geography/context, and equipment can also introduce challenges with comparison across studies. Where possible, results of systematic reviews and

meta-analyses are presented in this landscape.

3

Portable hemoglobinometers

Portable hemoglobinometers are often used to estimate hemoglobin in field settings, as they are easily

transported handheld devices that do not require access to refrigeration or electricity.21 Additionally,

portable hemoglobinometers are advantageous in that they require only a small sample of capillary blood,

provide instant quantitative results on a digital display, and are relatively inexpensive and simple to use,

requiring only basic training. Portable hemoglobinometer technology functions based on the principles of

colorimetry.

HemoCue® systems (HemoCue AB, Ängelholm, Sweden) are the most well-established portable

hemoglobinometers and are considered the reference method for point-of-care testing.22 HemoCue

released the HemoCue 201+ device in 1990, which was then followed by the HemoCue 301+.23 HemoCue

devices use reagent-based absorption photometry to measure hemoglobin at dual wavelengths. Blood is

collected via capillary draw into a microcuvette that is loaded into a reader, where it reacts with the

reagents and hemoglobin is converted to hemoglobinazide.21,24 Errors in measurement can be

introduced by improper cleaning of the device or improper blood-collection practices—particularly when

using capillary samples.25 For example, using the incorrect blood volume or “milking the finger” during

sample collection can influence the results.21,25 To address these issues, standardization protocols for

blood-sample collection have been developed.26 Quality controls are also required and available from

EuroTrol (Ede, The Netherlands).27

A number of studies have compared HemoCue device performance to various reference tests. Of note, a

recent systematic review found that HemoCue devices provide an unbiased, pooled estimate of

laboratory hemoglobin.28 Although HemoCue devices have been shown to have high accuracy and

precision in laboratory settings,29,30 greater variability is observed in field settings.21,25,31–34 Variability in

performance has also been observed between different devices, models, and operators.35–39

Apart from the HemoCue devices, a number of other portable hemoglobinometers have been developed

and are commercially available, including the TrueHb (Wrig Nanosystems, New Delhi, India) and the

URIT devices (URIT Medical Electronic Group Ltd., Guilin, China). A list can be found in table 3.

However, the HemoCue devices are currently the only portable hemoglobinometers recommended by

WHO.

Noninvasive approaches

Recent technological advancements have made noninvasive methods for point-of-care anemia screening

a promising new option. A summary of noninvasive hemoglobin assessment devices and methods can be

found in table 4. These methods do not require a blood sample to produce results, reducing the risk of

infection and eliminating patient pain involved in testing. Noninvasive devices also have an inherently

different cost structure than that of invasive methods, since they do not require additional material inputs

for each test administered (e.g., microcuvettes). Instead of analyzing blood hemoglobin levels directly,

noninvasive devices use spectrophotometry to estimate hemoglobin concentration based on light

wavelength or photometry to estimate hemoglobin concentration based on light intensity. However, the

methods used by these devices have not been recommended by WHO, and many are still in pilot or

validation phases. Overall, there is a current lack of evidence supporting their diagnostic accuracy.

4

Pronto® and Radical® Devices

Multiple generations of the Pronto® and Radical® devices manufactured by Masimo Corporation (Irvine,

California) use pulse CO-oximetry to monitor oxygen saturation in blood. These devices work by placing a

sensor that measures different wavelengths of light onto the tip of a patient’s ring finger. Noninvasive and

continuous hemoglobin SpHb® monitoring (Masimo Corp.) by more recent versions of these devices is

made possible by Masimo rainbow® technology that can measure light at a broader spectrum of

wavelengths. Current devices that use SpHb technology are Masimo’s Pronto Pulse and Radical-7® CO-

Oximeters®. The Pronto Pulse CO-Oximeter is a spot-check monitor powered by four AA alkaline

batteries that last for up to eight hours of use, and the Radical-7 is a continuous monitor that uses a

rechargeable nickel-metal hydride battery with four hours of battery life and a three-hour charge time. The

SpHb technology used by Masimo does not have the diagnostic power (accuracy, precision) of current

WHO recommended methods for determining hemoglobin levels and, therefore, is not intended as a

replacement for laboratory blood testing.28

NBM-200

Another method for noninvasive determination of hemoglobin is occlusion spectroscopy, as used by the

NBM-200 device developed by OrSense (Petah Tikva, Israel). Similar to pulse CO-oximetry, occlusion

spectroscopy relies on spectrophotometry to estimate hemoglobin concentration in the blood. However,

the NBM-200 device places a ring-shaped probe around the finger and temporarily applies pressure to

restrict blood flow, which creates an optical signal and results in a measurement. This approach does not

require an adequate perfusion rate or pulse rate, unlike pulse CO-oximetry.40 The NBM-200 operates with

four standard AA batteries or a built-in rechargeable lithium-ion backup battery.

Haemospect®

The Haemospect® device (MBR Optical systems, Wuppertal, Germany) uses transcutaneous reflection

spectroscopy to measure hemoglobin levels. The Haemospect works by placing a sensor on the palm

side of the dominant hand immediately below the index finger, and as subsequent measurements are

often necessary to obtain a reading, a second measurement can be taken by placing the sensor on the

forearm of the same arm.41 The sensor projects white light into the underlying tissue, and some of this

light is absorbed while the rest is reflected back to the device to be broken down into separate

wavelengths by a spectrometer and analyzed by an electronic evaluation unit connected to the system.42

HemaApp

HemaApp is an innovative smartphone application developed by electrical engineers and computer

scientists at the University of Washington (Seattle, Washington) that measures hemoglobin levels through

chromatic analysis by analyzing absorption properties of blood at different wavelengths of light.43 This

technology draws from previously existing noninvasive methods using spectrophotometry to assess blood

hemoglobin levels but leverages existing smartphone technology to offer a new and accessible strategy

for implementation. Accuracy of this diagnostic can be improved by augmenting HemaApp with

incandescent lights and infrared LED lights.43

ToucHb

ToucHb (Biosense, Irvine, California) is a unique noninvasive device in that it relies on reflectance

photometry as opposed to spectrophotometry. Instead of analyzing different wavelengths of light, it

5

assesses overall light intensity as a way to quantitatively measure pallor and estimate hemoglobin

concentration in the blood. This device captures an image of the patient’s exposed conjunctiva, which is

then used to measure pallor and predict blood hemoglobin concentration in grams per deciliter.9

6

Table 1. Comparison of selected point-of-care anemia screening devices against the minimum target product profile (TPP) criteria.

Key

Meets criteria Partially meets criteria Does not meet criteria N/A No information available

TPP Criteria

Invasive Noninvasive

Color Scales

Sahli’s method

PHMs Clinical signs

Pronto® Pulse Co-Oximeter

Radical-7®

NBM-200

ToucHb HemaApp Haemospect® HemoCue®

201+ TrueHb URIT-

12

Intended use/ use cases

Target population

End user

Infrastructure level

Clinical sensitivity and specificity

Complexity

Operating temperature

N/A N/A N/A N/A N/A

Sample collection and processing

Quality control N/A N/A N/A N/A

Target cost per result

N/A N/A N/A N/A N/A N/A N/A

Abbreviations: PHMs, portable hemoglobinometers

7

Table 2. Summary of anemia screening methods based on manual visual comparison of blood samples.

No. Product or Method Name

Manufacturer (Location)

Web Link Price (USD) Sensitivity/ Specificity (95% Confidence Interval)

Peer-Reviewed References

1 WHO Colour Scale Copack GmbH (Oststeinbek, Germany)

Link

Approximately $10 for the basic kit (scale, instructions, and 200 test strips)b

Estimates vary. According to a systematic review by Marn & Critchley (2016)10: Pooled sensitivity: 80% (68%–88%)10 Pooled specificity: 80% (59%–91%)10

Pooled sensitivity (severe anemia): 57% (36%–76%)10 Pooled specificity (severe anemia): 99.6% (95%–99.9%)10

[10,44–60]

2 HCS-HLL Hindustan Lifecare Ltd. (Thiruvananthapuram, India)

No direct product link available. Manufacturer’s website: Link

N/A

Sensitivity (capillary sample, accuracy to screen): 92.0% (90.4%–93.3%)9 Specificity (capillary sample, accuracy to screen): 21.9% (19.6%–24.2%)9

Sensitivity (venous sample, accuracy to screen): 69.6% (67.1%–71.9%)9 Specificity (venous sample, accuracy to screen): 59.5% (56.8%–62.2%)9 Sensitivity (capillary sample, accuracy to screen for treating): 90.3% (88.2%–92.2%)9 Specificity (capillary sample, accuracy to screen for treating): 42.2% (39.9%–44.5%)9 Sensitivity (venous sample, accuracy to screen for treating): 67.1% (63.9%–70.2%)9 Specificity (venous sample, accuracy to screen for treating): 72.8% (70.7%–74.8%)9

[9]

b Source: http://www.who.int/medical_devices/publications/en/HbCS_Research_AgendaStudyDesign.pdf.

8

3 Sahli’s method Multiple manufacturers of Sahli’s hemoglobinometers

Example: Link

Approx. $11 for the Sahli hemoglobinometer.c Additional supplies are also required.

Estimates vary. Sensitivity 92.3%47 Specificity: 39.0%47 Sensitivity: 98.2%60 Specificity: 66.2%60 Sensitivity: 86% (75%–94%)61,62 Specificity: 83% (68%–93%)61,62

[16,47,54,60,61–63]

4 Microhematocrit readers

Multiple reader types and manufactures

Example: Link

Varies depending upon reader type. Some readers range from $25–$75d,e

Estimates vary, depending upon the reader type and sample preparation. For manual readers, sensitivity: greater than 90% if centrifugal speed is consistent.14 Sensitivity: 90.0%64 Specificity: 43.5%64

[14,17,18,20,64]

c Source: https://www.indiamart.com/proddetail/sahli-type-haemoglobin-meter-15672891530.html. d Source: https://www.grainger.com/product/54PC09?cm_mmc=PPC:+Google+PLA&s_kwcid=AL!2966!3!50916768717!!!g!111150354597!&ef_id=Wg5DAwAAAAGL7tLm:20180619171605:s. e Source: https://mfimedical.com/products/unico-microhematocrit-reader?variant=19995835011&gclid=CjwKCAjw06LZBRBNEiwA2vgMVaQyJIY46k4CN9lsTAdyMdiQTzFAz-

yLqDY30oY2LDcqSVCzk2zq8BoCZTwQAvD_BwE.

9

Table 3. Summary of portable hemoglobinometers.

No. Product Name Manufacturer (Location)

Web Link Price (USD) Sensitivity/ Specificity (95% Confidence Interval)

Peer-Reviewed References

1 HemoCue® Hb 201+ HemoCue AB (Ängelholm, Sweden)

Link Approximately $320f

Estimates vary. Only a selection are presented herein. Sensitivity (≤11 g/dl): 85% (79%–90%)48,61 Specificity (≤11 g/dl): 80% (76%–83%)48,61 Sensitivity (capillary blood, adults ≥17 years): 79%25 Specificity (capillary blood, adults ≥17 years): 97%25 Sensitivity (venous blood, adults ≥17 years): 86%25 Specificity (venous blood, adults ≥17 years): 97%25 Sensitivity (capillary blood, children 0.5–15 years): 84%25 Specificity (capillary blood, children 0.5–15 years): 93%25 Sensitivity (venous blood, children 0.5–15 years): 87%25 Specificity (venous blood, children 0.5–15 years): 93%25 Sensitivity: 70.6%34 Specificity: 95.2%34

[21, 25,28–32,34,48,61]

2 HemoCue® 301+ HemoCue AB (Ängelholm, Sweden)

Link

HemoCue Hb 301 Analyzer price: 100 units = US$527.30 per unit = Total cost US$52,730

Estimates vary. Only a selection are presented herein. Sensitivity (females, 12 g/dl cutoff): 72%65 Specificity (females, 12 g/dl cutoff): 70%65 Sensitivity (males, 13 g/dl cutoff): 50%65 Specificity (males, 13 g/dl cutoff): 70%65

[35–37,39,65]

f Source: http://www.medicaldevicedepot.com/Hemocue-Hb-201-Analyzer-p/h1promo.htm?dfw_tracker=3918-51661&gclid=CjwKCAjw9qfZBRA5EiwAiq0AbbzPdvc5BZt24SnjpqpF4pToVYODwMww_rtYXHf-

a5UaMB-w1nlcMxoC9k4QAvD_BwE.

10

500 units = $511.41 per unit = Total cost US$255,741 1,000 units = $474.57 per unit = Total cost US$474,570g

Sensitivity (females and males, respective cutoffs): 70%65 Specificity (females and males, respective cutoffs): 70%65 Sensitivity: 61.9%37 Specificity: 100%37

3 DiaSpect Tm EKF Diagnostics (Cardiff, United Kingdom)

Link

100 units = €195 per unit 500 units = €175 per unit 1,000 units = €150 per unith

Sensitivity: 98.1%66 Specificity: 78.4%66

[66]

4 HemoPoint® H2 EKF Diagnostics (Cardiff, United Kingdom)

Link

HemoPoint H2 Analyzer: 100 units = US$600 per unit = Total cost US$60,000 500 units = US$600 per unit = Total cost US$300,000 1,000 units = US$500 per unit = Total cost US$500,000 HemoPoint H2 Microcuvettes: 2x50 cuvettes = US$86 4x50 cuvettes = US$165

N/A N/A

g Source: Manufacturer price quote (Ex Works) for Ethiopia. h Source: Manufacturer price quote (Ex Works) for Ethiopia.

11

HemoPoint H2 Hgb Controls (Bi-Level): 6x1.5 mL = US$48 2x1.5 mL = US$34 i

5 True Hb™ Wrig Nanosystems (New Delhi, India)

Link N/A

Sensitivity (capillary samples, accuracy to screen): 82.1% (79.8%–84.2%)9 Specificity (capillary samples, accuracy to screen): 77.9% (75.3%–80.3%)9 Sensitivity (venous samples, accuracy to screen): 74.4% (71.9%–76.8%)9 Specificity (venous samples, accuracy to screen): 86.9% (84.8%–88.8%)9 Sensitivity (capillary samples, accuracy to screen for treating): 79.4% (76.4%–82.1%)9 Specificity (capillary samples, accuracy to screen for treating): 87.1% (85.3%–88.7%)9 Sensitivity (venous samples, accuracy to screen for treating): 70.7% (67.4%–73.9%)9 Specificity (venous samples, accuracy to screen for treating): 93.8% (92.5%–94.9%)9

[9,67]

6 HemoControl EKF Diagnostics (Cardiff, United Kingdom)

Link

100 units = €475 per unit 500 units = €410 per unit 1,000 units = €345 per unitj

Estimates vary. Sensitivity: 86.8%66 Specificity: 94.7%66 Sensitivity: 83.3%68 Specificity: 87.9%68

[66,68]

7 Anemia and Malnutrition Device

Path Shodh (Bangalore, India)

Link Contact manufacturerk

N/A N/A

i Source: Manufacturer price quote (Ex Works) for Ethiopia. j Source: Manufacturer price quote (Ex Works) for Ethiopia. k No response received from manufacturer.

12

8 i-STAT® System Abbott (Princeton, NJ)

Link

i-STAT 1 Analyzer including Downloader, Printer, and Electronic Simulator: US$7,000 EGC+ Cartridge (Bx/25)—sodium, potassium, hemoglobin, hematocrit, pH, PCO2, PO2, TCO2, HCO3, BE, sO2: US$135l

N/A [69]

9 QDx Hemostat DiaSys Diagnostic Systems GmbH (Holzheim, Germany)

Link Contact manufacturerm

N/A N/A

10 AccuQuik™ Hemoglobin System

AccuQuik Test Systems (Wilmington, DE)

Link Contact manufacturern

N/A N/A

11 CompoLab TM Fresnius Kabi India Pvt. Ltd. (Pune, India)

Link Contact manufacturero

N/A [42,70,71]

12 CompoLab TS Fresnius Kabi India Pvt. Ltd. (Pune, India)

Link Contact manufacturerp

N/A [42,70,71]

13 URIT-12 URIT Medical Electronic Group Ltd. (Guilin, China)

Link

URIT-12 Hemoglobin Meter: US$80 for 100 units; US$75 for 500 units; US$68 for 1,000 units URIT H12 Hemoglobin test (25 strips per bottle): US$10

Community-based, clinical setting: Sensitivity (females; 12 g/dl cutoff): 100%65 Specificity (females; 12 g/dl cutoff): 7%65 Sensitivity (males,13 g/dl cutoff): 100%65 Specificity (males,13 g/dl cutoff): 6%65 Sensitivity (males and females, with respective cutoffs): 100%65 Specificity (males and females, with respective cutoffs): 7%65

[65,72]

l Source: Manufacturer price quote for Ethiopia. Additional six percent freight for cartridges and four percent freight for instrument for Cargo Insurance Paid (CIP) shipping terms. m No response received from manufacturer. n No quote received from manufacturer. o No response received from manufacturer. p No response received from manufacturer.

13

URIT HQ-A Hemoglobin Control (1 mL/ bottle): US$12 for 3 bottlesq

14 URIT-15 URIT Medical Electronic Group Ltd. (Guilin, China)

Link

Only available in domestic market. Not available in international market until late 2018.r

N/A N/A

15 Hemosmart Gold ApexBio (Hsinchu City, Taiwan)

Link Price negotiable.s N/A N/A

16 Hemachroma Plus Boditech Med Inc. (Chungcheon-si, South Korea)

Link Contact manufacturert

N/A N/A

17 Benecheck HB General Life Biotechnology (New Taipei City, Taiwan)

Link Contact manufactureru

N/A [73]

18 CERA-CHEK™ HB plus

GCMedis (Cheonan, South Korea)

Link Contact manufacturerv

N/A N/A

19 HG-220 APEL Co. Ltd. (Kawaguchi, Japan)

Link Approx. $1,800–$2,000w

N/A N/A

q Source: Manufacturer price quote (Ex Works) for Ethiopia. r Source: Manufacturer correspondence. s Source: Manufacturer correspondence. t No response received from manufacturer. u No response received from manufacturer. v No response received from manufacturer. w Source: http://www.commercedragon.com/product/portable-bilirubin-meter-hemoglobin-meter220-made-japan_75951.

14

Table 4. Summary of noninvasive anemia screening devices and methods.

No. Product or Approach Name

Manufacturer (Location)

Web Link Price Sensitivity/ Specificity (95% Confidence Interval)

Peer-Reviewed References

1 Haemospect® MBR Optical Systems (Wuppertal, Germany)

Link

US$500x

Estimates vary. Sensitivity: 66.7%68 Specificity: 77.1%68 Sensitivity (men): 3.5%74 Specificity (men): 95.9%74

Sensitivity (women): 10.8%74

Specificity (women): 95.0%74

[41,42,68,70,74]

2 Pronto® Pulse CO-Oximeter®

Masimo Corp (Irvine, California, USA)

Link

$522y –$699z

Estimates vary. Sensitivity: 82% (75–90%)75 Specificity: 65% (56%–74%)75

Sensitivity (DCI mini): 66–72%76

Specificity (DCI mini): 70–84%76

Sensitivity (men): 93%77

Sensitivity (women): 75%77 Specificity (men): 77%77

Specificity (women): 81%77

Sensitivity: 95.4%78

Specificity: 63.8%78

Sensitivity: 93%79

Specificity: 83%79

[28,75–96]

3 Radical-7® Masimo Corp (Irvine, California, USA)

Link

$1,295aa–$2,795bb

Estimates vary. Sensitivity: 61% (32%–86%)123

Specificity: 85% (55%–98%)123 Sensitivity (MetHb): 92.6–100%124

[28,82,97– 125]

x Source: https://www.frontierhealth.co/products/haemospect-hemoglobin-device. y Source: https://www.cascadehealthcaresolutions.com/pulse-co-oximeter-pronto-p/9167ea.htm. z Source: https://www.concordhealthsupply.com/Masimo-Pronto-for-Spot-checking-hemoglobin-SpHb-p/mas-3580-3581-3584.htm. aa Source: http://pacificmedicalsupply.com/masimo-oem-9153-radical-7-handheld-blue-screen-pulse-co-oximeter/. bb Source: https://www.cpapusa.com/radical-7.html.

15

Specificity (MetHb): 92.4–100.0%124 Sensitivity: 79%125

4 NBM-200 Orsense (Petah-Tikva, Isreal)

Link

Approx. £1100cc

Estimates vary. Sensitivity: 70.59% (52.52%–84.90%)126

Specificity: 98.93% (97.51%–99.65%)126

Sensitivity (Men): 12.1%74 Specificity (Men): 98.6%74

Sensitivity (Women): 17.0%74 Specificity (Women): 94.6%74

Sensitivity: 71.7%66

Specificity: 79.5%66 Sensitivity (Men, Hb<13.5 g/dL): 14.47%127

Specificity (Men, Hb<13.5 g/dL): 98.89%127

Sensitivity (Women, Hb<12.5 g/dL): 32.34%127

Specificity (Women, Hb<12.5 g/dL): 95.12%127 Sensitivity: 38.6% (28.1–50.3%)40 Specificity: 93.6% (90.9–95.5%)40

Sensitivity: 98%79

Specificity: 97%79

[40,66,74,79,96,126 –128]

5 ToucHb Biosense (Irvine, CA)

Link

Contact manufacturerdd

Sensitivity (accuracy to screen patients with anemia): 73.1% (70.7%–75.4%)9 Specificity (accuracy to screen patients with anemia): 51.5% (48.7%–54.3%)9

Sensitivity (accuracy to screen patients for treating anemia): 44.3% (41.7%–47.0%)9

Specificity (accuracy to screen patients for treating anemia): 80.5% (78.2%–82.7%)9

[9]

cc Source: http://innovations.bmj.com/content/bmjinnov/early/2016/08/10/bmjinnov-2016-000139.full.pdf. dd No response received from manufacturer.

16

6 HemaApp University of Washington (Seattle, WA)

Link

N/A

Sensitivity (smartphone LEDs): 78.6%43

Specificity (Smartphone LEDs): 70.6%43

Sensitivity (incandescent light): 85.7%43

Specificity (incandescent light): 70.6%43

Sensitivity (incandescent light & custom LED): 85.7%43

Specificity (incandescent light & custom LED): 76.5%43

[43,129]

7 Hb Meter App

N/A This product has been field tested by Africare’s Mwanzo Bora Nutrition Program, with funding from USAID.

Link

N/A N/A N/A

8

Quantifying conjunctival pallor using digital photographs

N/A N/A N/A

Sensitivity (iPhone 5s camera): 74% (52–90%)130

Specificity (iPhone 5s camera): 71% (49%–87%)130

Sensitivity (Panasonic DMC-LX5 digital camera): 57% (34%–77%)130

Specificity (Panasonic DMC-LX5 digital camera): 83% (63%–95%)130

[130]

9

Measuring red blood cell zinc protoporphyrin in the microcirculation of the lower lip using optical fiber probes

N/A N/A N/A Sensitivity: 97% (87%–100%)131

Specificity: 90% (73%–98%)131 [131]

17

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