Diagnostics Instrument–Target

Product Profile

Diagnostic Instrument: Hemoglobinometer

Version 1.1–June 2018

Mailing Address

PO Box 900922

Seattle, WA 98109 USA

Street Address

2201 Westlake Avenue

Suite 200

Seattle, WA 98121 USA

www.path.org

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Contents

EXECUTIVE SUMMARY .............................................................................................................................. 1

PRODUCT USE SUMMARY / MEDICAL NEED / DIFFERENTIATION STRATEGY ................................. 4

TARGET POPULATIONS AND USE CASES .............................................................................................. 5

TARGET PERFORMANCE ........................................................................................................................ 10

PRODUCT CONFIGURATION AND FORMAT .......................................................................................... 13

PRODUCT COSTS AND CHANNELS TO MARKET................................................................................. 17

REFERENCES ............................................................................................................................................ 19

CHANGE MANAGEMENT ......................................................................................................................... 22

1

Executive summary

Variable Minimum Optimistic

Product use

Intended use

The diagnostic device is intended to measure blood hemoglobin (Hb) concentration. The test will provide results expressed in grams Hb per deciliter and must clinically differentiate mild, moderate, and severe anemia.

Same.

Target population

Pregnant women receiving care at antenatal care (ANC) clinics.

Pregnant women receiving ANC in all settings, postpartum women (0–6 months after delivery), and prepregnancy girls and women.

End users Trained facility-based health care workers: nurses, medical officers, and midwives.

Trained facility- and community-based health care workers.

Infrastructure level

ANC clinics in community health facilities, district health facilities and hospitals, and regional hospitals. Tier 4 health care settings and above (WHO heath facility classifications).

All heath care settings where women seek care during the pre- and postnatal period, including through mobile clinics and home visits.

Target countries All countries categorized by WHO as having severe (>40% prevalence) or moderate (20%–39% prevalence) anemia public health problems.

All countries where antenatal services are provided in settings without access to full blood-count testing.

Product performance

2

Variable Minimum Optimistic

Clinical sensitivity and specificity

Sensitivity >85% and specificity >80% in each trimester of pregnancy at the moderate anemia threshold of 11.0g/dL and the severe anemia threshold point of 7.0g/dL.

Sensitivity >95% and specificity >90% in each trimester of pregnancy at the moderate anemia threshold of 11.0g/dL and the severe anemia threshold point of 7.0g/dL.

Precision Coefficient of variation (CV) should not exceed 6%. To be determined.

Analytical accuracy relative to reference method

In comparison to the standard reference, 80% of the results must fall within +1.0g Hb/dL of the reference across the range of Hb concentrations.

In comparison to the standard reference, 85% of the results must fall within +1.0g Hb/dL of the reference across the range of Hb concentrations.

Operating temperature The device should be able to operate at 15oC–35oC, 30%–85% humidity.

The device should be able to operate at 15oC–40oC, 20%–90% humidity.

Reference methods

Standard reference method for capillary or venous blood: 1. HemoCue®* (capillary blood samples). 2. Automated hematology analyzer (venous blood sample).

Both standard reference methods for capillary or venous blood.

Product design

Complexity No more than 5 steps. Requires one health worker to execute.

No more than 3 steps. Requires one health worker to execute.

Instrumentation Handheld, portable reader device and disposable/ consumable component (less than 500 grams).

Handheld portable device with no consumables.

3

Variable Minimum Optimistic

Sample type Capillary blood from fingerstick and venous whole blood collected in anticoagulant.

Noninvasive device: none.

Sample collection and processing Finger prick using a standardized lancet or venipuncture with no sample processing.

Noninvasive sensor probe: none.

Quality control Manufacturer provides controls specific for test in intended use

Compatible with commercial hemoglobin controls. Clear instructions for quality controls appropriate for intended use.

Costs and channels to market

Target cost per result Less than US$0.75 cents. Includes the consumable cost plus the reader cost pre result.

To be determined.

Channels to market

Through UNICEF Supply Division, Unitaid, and the Global Financing Facility. Additionally, local distributors to procure the consumable components locally.

Same.

*HemoCue is a registered trademark of HemoCue AB, Ängelholm, Sweden.

Note: UNICEF, United Nations Children’s Fund; WHO, World Health Organization.

4

Product use summary / medical need / differentiation strategy

Clinical and/or surveillance need:

Improving the nutritional status of women before and during pregnancy can reduce the risk of adverse birth outcomes. Anemia is a significant

driver of poor nutritional status and the global prevalence of anemia among pregnant women is about 38%.1 Clinical assessment is a common

but inaccurate method for detecting anemia. Laboratory-based methods, such as an automated hematology analyzer, are unsuitable for use in

antenatal care (ANC) settings. Currently available point-of-care tests are considered expensive, and the high cost can prohibit routine use.

There is a need for a point-of-care (POC) hemoglobinometer for routine screening of pregnant women for anemia in all health settings where

women seek ANC. More accurate and reliable anemia-detection tools will support better clinical decision-making, help stratify pregnant women

according to their risk of anemia-related pregnancy complications, and potentially improve provider and patient compliance with recommended

anemia treatment options, such as iron-folic acid supplementation.

Intended use case scenario:

A low-cost POC hemoglobinometer will be used for routine screening in ANC clinics. The 2016 World Health Organization (WHO)

recommendations on ANC for a positive pregnancy experience recommends routine anemia testing at weeks 12, 26, and 36 in countries where

the prevalence of anemia is at least 40% among pregnant women.1 The test will evaluate hemoglobin (Hb) concentration in capillary blood as

part of routine screening at ANC and at delivery. The test will identify women with all severity levels of anemia (mild, moderate, severe) and

provide accurate results to inform treatment options and monitor hemoglobin concentration throughout pregnancy. Trained clinicians and

facility-based health workers, including nurses and midwives as well was trained community health workers, will use the test in all health

settings where women seek ANC, primarily in ANC clinics.

5

Target populations and use cases

Target Annotation

3.1 Intended Use

The diagnostic device is intended to measure blood hemoglobin

(Hb) concentration. The test will provide results expressed in

grams Hb per deciliter and must clinically differentiate mild,

moderate, and severe anemia.

A robust, low-cost, accessible, and accurate point-of-care (POC) Hb

measurement tool would enable routine anemia screening within the

antenatal care (ANC) programs in low- and middle-income countries

(LMIC).

This diagnostic must be able to discriminate between healthy women and

women with mild anemia, moderate anemia, and severe anemia with

sufficient accuracy to support clinical decision-making. While this diagnostic

must identify all cases of anemia (<11.0g/dL) to ensure adequate treatment

and follow-up is received, the priority is to identify all cases of severe

anemia (<7.0g/dL). The results will be used to inform treatment options,

including an iron and folic acid (IFA) supplementation regimen. Depending

on the severity of anemia and the time of testing, women may receive IFA

supplements, counseling, and treatment regarding malaria or deworming

and iron intravenous or intramuscular injections. The result may also be

used to facilitate referral for treatment at a higher-tier health facility.

ANC is delivered in both the public and private health sectors.2 ANC is

commonly provided in primary health facilities. As such, the test will need to

provide a result at the POC and be no more complex than current

components of ANC care, such as blood pressure measurement or malaria

rapid tests.

Screening may be achieved through invasive tests that require a blood

sample or noninvasive tests that require no sample. Some literature and

clinical experts report that noninvasive devices have significant

performance limitations that limit their utility in clinical decision-making.3–5

6

3.2 Target Population

Minimum: Pregnant women receiving care at ANC clinics.

Optimistic: Pregnant women receive care in all ANC settings

(home, mobile, and community clinics), postpartum women (0–6

months after delivery), and prepregnancy girls and women.

The primary target is pregnant women undergoing routine ANC visits at

primary clinics in LMIC. The 2016 WHO recommendations on ANC for a

positive pregnancy experience recommends routine anemia testing at

weeks 12, 26, and 36 in countries where the prevalence of anemia is at

least 40% among pregnant women.1 If there is no Hb result on record, Hb

should be checked when pregnant women arrive at a birthing facility for

delivery in order to understand risk of postpartum haemorrhage.6

In addition to routine ANC, the test may also be used outside of clinic

settings and in populations before and after pregnancy. Stakeholders

interviewed reported an interest in expanding anemia screening to the

prepregnancy and postnatal period and through screening in school

settings and during postpartum care.6,7

3.3 End Users

Minimum: Facility-based health care workers: nurses, medical

officers, and midwives.

Optimistic: Facility and community-based health care workers.

End users of the test will vary across countries and facility types.6 All users

will receive training in the use of the test along with other components of

routine screening in ANC. ANC services at facilities are generally delivered

by nurses, medical officers, clinical officers, and midwives. A formative

usability assessment in a representative ANC setting in Ghana found that

end users ranged from community health nurses to laboratory technicians

with between 2 and 5 years of medical training.

Optimistically, a POC Hb measurement tool would be sufficiently robust

and simple to use outside of the ANC clinic setting. This would expand

access to anemia testing in the prepregnancy and postnatal period through

home visits and community- and school-based screening and entail use by

lower-skilled community health workers.

3.4 Infrastructure Level This diagnostic will be used at primary care clinics and other health facilities

where ANC is provided, such as district hospitals or facilities with limited or

7

Minimum: ANC clinics in community health facilities, district

health facilities and hospitals, and regional hospitals. Tier 4 health

care settings and above (WHO heath facility classifications).

Optimistic: All heath care settings where women seek care

during the pre- and postnatal period, including through mobile

clinics and home visits.

no laboratory capacity. Full blood-count testing is recommended in facilities

where this level of laboratory capacity is present.1

Optimistically, a POC Hb measurement tool would be sufficiently robust

and simple to use outside of the ANC clinic setting. This would expand

access to anemia testing in the prepregnancy and postnatal period through

home visits and community- and school- based screening and entail use by

lower-skilled community health workers.

3.5 Target Countries

Minimum: All countries categorized by WHO as having severe

(>40% prevalence) or moderate (20%–39% prevalence) anemia

public health problems.

Optimistic: All countries where antenatal services are provided

in settings without access to full blood-count testing.

All countries with severe or moderate prevalence of anemia in pregnant

women would benefit from a POC Hb measurement tool to expand access

to screening in ANC and reduce the burden of maternal anemia. Globally,

in countries with a lower prevalence of anemia, a POC hemoglobin

measurement tool will expand access to anemia screening in settings

without access to full blood-count testing.

As a target launch country, India is well suited in terms of health need and

policy alignment. The prevalence of anemia during pregnancy in India is

one of the highest globally, estimated at 59%.8 Operational guidelines to

reduce the prevalence of anemia in India among all at-risk groups include

the use of digital hemoglobinometers, indicating an opportunity to introduce

and scale hemoglobin measurement tools.9

8

Geographic summary of anemia prevalence in pregnant women

globally.(10)

3.6 Target Customer

Public and private clinics that provide ANC services. In order for

diagnostics to be procured and used in public ANC clinics, they must be

registered in-country and be included on lists of products that can be

covered by the national health insurance program. A hemoglobinometer is

included in the World Health Organization Model List of

Essential In Vitro Diagnostics.

Additional comments:

Fit with clinical workflow / linkage to care.

A low-cost POC hemoglobinometer would enable routine screenings of Hb

concentration among pregnant women at 12, 26, and 36 weeks, as per

WHO recommendations, and be offered for free as part of ANC.1 There are

9

some reports of women being asked to pay for the cost of screening in a

laboratory.11 Anemia screening and use of the hemoglobinometer will be

done in parallel with other recommended ANC screening practices included

in global and national guidelines.1 Health workers using the diagnostic need

to be able to read the result of the test and interpret it in the context of the

relevant anemia thresholds and other clinical indicators and measurements

taken during ANC.

Providers will conduct the test at the POC. The result must be available

immediately and used to communicate the hemoglobin measurement value

and anemia status. The result will be used to inform treatment options,

including iron and folic acid (IFA) supplementation regimen. Depending on

the severity of anemia and the time of testing, women may receive IFA

supplements, counseling, and treatment regarding malaria or deworming

and iron intravenous or intramuscular injections. The result may also be

used to facilitate referral for treatment at a higher-tier health facility.

10

Target performance

Target Annotation

4.1 Clinical Sensitivity and Specificity

Minimum: Sensitivity >85% and specificity >80% in each

trimester of pregnancy at the moderate anemia threshold of

11.0g/dL and the severe anemia threshold point of 7.0g/dL.

Optimistic: Sensitivity >95% and specificity >90% in each

trimester of pregnancy at the moderate anemia threshold of

11.0g/dL and the severe anemia threshold point of 7.0g/dL.

This diagnostic must discriminate between healthy individuals, mild anemia,

moderate anemia, and severe anemia with sufficient accuracy to support

clinical decision-making, as in routine ANC there will be limited or no access

to confirmatory testing.

Evidence generated in multiple studies and reviewed by WHO found that

some POC hemoglobin measurement techniques have sufficient performance

to improve detection of anemia in pregnancy.12–14 Expert interviews indicated

that sensitivity is prioritized over specificity to identify cases of anemia and, in

particular, all cases of severe anemia.6

Some evidence suggests that Hb measurement tools, particularly noninvasive

tools, may have insufficient performance—specifically, decreased accuracy in

the second or third trimester due to changes in circulatory status.3 There may

be a need for further evidence to inform the risk and the cost of both over-

and underestimating anemia in pregnant women.

4.2 Precision

Minimum: Coefficient of variation (CV) should not exceed 6%.

Optimistic: To be determined.

Hb concentration in capillary blood likely varies more than in venous blood

due to the variable presence of interstitial fluids. This variation may be

compounded by varying finger-prick techniques that may impact precision

measurements.14 The standard reference for capillary measurement—the

HemoCue®*—reports CV ranging from 0.51-1.3%.15

This variation may be addressed through repeat measurements, which may

be facilitated by multiple ANC visits over the course of the pregnancy.

11

Minimal and optimistic precision criteria may warrant further study. The

criteria reported here take into account the precision estimates of the

standard reference for capillary measurement. The optimal precision criteria

should be a judgement of the corresponding clinical risk associated with

missing someone with severe anemia or the cost to the health system of

overestimating anemia prevalence or severity.

4.3 Analytical Accuracy Relative to Reference Method

Minimum: In comparison to the standard reference, 80% of

the results must fall within +1.0g Hb/dL of the reference across

the range of hemoglobin concentrations.

Optimistic: In comparison to the standard reference, 85% of

the results must fall within +1.0g Hb/dL of the reference across

the range of hemoglobin concentrations.

The clinically acceptable bias is within 1.0g/dL of the reference across the

dynamic range of Hb concentrations (4 – 17g/dL).4,16

The POC results should be strongly correlated with reference standard with a

correlation coefficient >0.80.16–19

Mean difference (bias) should be less than or equal to +0.5g/dL. Absolute

mean difference should be less than 1.0g/dL in each trimester.3,4,16,17,20,21

4.4 Limit of Detection

Minimum: Clinically relevent threshold of 4g Hb/ dL or lower.

Optimistic: Same.

This diagnostic must be able to discriminate between healthy women and

women with mild anemia, moderate anemia, and severe anemia to inform

linkage to care. Global and national clinical guidelines indicate that

measurements below 4 grams Hb/ dL do not indicate different clinical

management strategies. The hemoglobin measurements below 4 g/ dL

require blood transfusion.22–24

4.5 Time to Result

Minimum: 5 minutes or less.

Optimistic: 2 minutes or less.

The time to result should be comparable with other diagnostics used in ANC.

This may include blood pressure measurements and rapid diagnostic tests for

HIV or malaria, which entail a 10–15 min time to result. The HemoCue®

requires 15–60 seconds to a result.15

4.6 Throughput

Minimum: 1 sample per test run.

In an ANC setting, a provider will see one patient at a time. The volume of

patients attending ANC will vary across facilities. One study in a

12

Optimistic: Same.

representative ANC setting found that a provider may see up to 8 women per

day and thus run up to 8 tests per day.25

4.7 Operating Temperature

Minimum: The device should be able to operate at 15oC–

35oC, 30%–85% humidity.

Optimistic: The device should be able to operate at 15oC–

40oC, 20%–90% humidity.

In a study monitoring the temperature and humidity at surveillance sites in

four African countries, the mean and median operating temperatures were

26.6°C and 26.4°C, respectively, with a range of 17.6°C–37.0°C.26 For the

same sites the mean and median relative humidity values were 70.4% and

72.1%, with a range of 40.2% to 119.5%.26 These are similar to expected

conditions in ANC clinics in intended-use settings.

Recent field testing in ANC clinics suggest that technologies used in ANC

need to be robust to extreme environmental conditions, including

temperatures of about 35.0°C. Certain models of the HemoCue® for POC

capillary testing are more robust to extreme temperatures than others.27

*4.8 Reference Methods

Minimum: Standard reference method for capillary or venous

blood:

1. HemoCue (capillary blood samples).

2. Automated hematology analyzer (venous blood sample).

Optimistic: Both standard reference methods for capillary or

venous blood.

The test should be comparable to reference standing using both capillary

blood (HemoCue®) and venous blood (automated analyzer).28 There is

extensive data demonstrating the accuracy of the HemoCue® compared to

the reference automated hematology analyzer.29 However, sufficient

differences are also evident and, if possible, both methods should be used as

reference methods to triangulate.

*HemoCue is a registered trademark of HemoCue AB, Ängelholm, Sweden.

13

Product configuration and format

Target Annotation

5.1 Complexity

Minimum: No more than 5 steps. Requires only one health worker to operate. Optimistic: No more than 3 steps. Requires only one health worker to operate.

If an invasive test is used, the trained health care worker will use an alcohol

wipe to clean the finger. A lancet will be used to prick the finger to obtain a

capillary blood sample, applied to the test device. The hemoglobin diagnostic

will then measure the blood sample. A noninvasive test will require fewer

steps but may require navigating digital interface. The device must be

appropriate for the setting with respect to cost, resources required, human

capacity, and usability/acceptability.12 Ease of use is a critical feature for

widespread adoption of diagnostic technologies in low-resource settings.

5.2 Instrumentation Minimum: Handheld, portable reader device and disposable/ consumable component for individual measurement. Optimistic: Handheld portable device with no consumables.

Instrumentation for an invasive test includes a reader plus consumables, a

strip or a cuvette. Instrumentation for noninvasive test includes a digital

device either with or without a probe with a sensor. If a noninvasive test is

used, the instrument might be a mobile platform that includes other

diagnostics, clinical support tools, or decision-making algorithms. The

complexity of clinical algorithms in antenatal care (ANC) settings are well

suited to translation to a digital platform and could improve ANC service

delivery and health outcomes.30 Instruments must be robust devices, resilient

to high heat, humidity, and dusty environments.

5.3 Power Requirements Minimum: AC adapter for running on power with battery backup. Optimistic: Same.

Some ANC facilities do not have electricity and will require battery-operated

devices that can operate during all ANC hours (sometime more than 8 hours

per day).25

5.4 Quality Control Minimum: Manufacturer provides controls configured appropriately for intended use.

Some commercially available controls may require cold chain or other

infrastructure. Controls need to be able to be used in the same setting by the

same target end user of the test.

14

Optimistic: Compatible with commercial hemoglobin controls and clear instructions for use, appropriate for use in low- and middle-income countries (LMIC) ANC settings.

5.5 Time to Result

Minimum: 5 minutes or less.

Optimistic: 2 minutes or less.

The time to result should be comparable with other diagnostics used in ANC

settings. This may include blood pressure measurements and rapid

diagnostic tests for HIV or malaria. The standard reference for capillary

measurement requires 15–60 seconds to a result.15

5.6 Throughput

Minimum: 1 sample per test run.

Optimistic: Same.

In an ANC setting, a provider will see one patient at a time. The volume of

patients attending ANC will vary across facilities. One study in a

representative ANC setting found that a provider may see up to 8 women per

day and thus run up to 8 tests per day, though others may see significantly

more.25

5.7 Sample Type Minimum: Capillary blood from fingerstick and venous whole blood collected in anticoagulant. Optimistic: Noninvasive device: none.

In order to demonstrate performance and validate tests for the ANC intended

use, invasive devices must be run using capillary blood collected through

fingerstick. Noninvasive devices will require no specimen and can more easily

obtain repeat measurements, suggested in some testing protocols.14

However, some literature and clinical experts report that noninvasive devices

have significant performance limitations that limit their utility in clinical

decision-making. More performance data on noninvasive devices is needed.3–

5

5.8 Sample Collection and Processing Minimum: Finger prick or venipuncture with no sample processing. Optimistic: Noninvasive sensor probe: none.

Test should be resilient to varying finger-prick and blood-application

techniques between users.14

5.9 Sample Volume Minimum: One blood drop (10uL). Optimistic: Noninvasive: none.

The size of the blood drop must not influence the hemoglobin concentration

result. Alternatively, the device must have a mechanism to standardize the

amount of blood read by the device. PATH experiments with 2, 5, 10, and

20 uL indicated that the size of the blood drop may influence the hemoglobin

measurement. If blood-drop size does influence the result, then the device

15

should include an error message to alert the user that the volume was

insufficient.

5.10 Target Analyte Minimum: Hemoglobin concentration Optimistic: Same

Expert interviews indicated that clinicians would greatly benefit from a

diagnostic that, in addition to Hb measurement, provided additional

information regarding the root cause of anemia among ANC patients. This

might include infection, malaria, and/or hemoglobinopathies or dietary

deficiencies of iron, folate, and vitamin A.

5.11 Calibration Minimum: Manufacturer provides all required calibration and specifics when and how device must be calibrated. Optimistic: No calibration needed.

Readers with disposable strips may need to be recalibrated when a new lot is

used or at other regular intervals. A digital device may require no calibration.

5.12 Data Handling Minimum: None. Optimistic: Up to 500 previous test results would be stored on device and downloaded via USB or other connection.

Data-management method will need to be compatible with local record

system. Many settings use an ANC booklet kept by patient that tracks

pregnancy health record during and between pregnancies. The device output,

including any digital version of the results, should be compatible with local

systems.

5.13 Other Supplies Needed Minimum: Lancets and alcohol swabs. Optimistic: None.

Apart from supplies to conduct blood sample collection, the kit should contain

all necessary supplies for running the test.

5.14 Waste Disposal Minimum: Does not include material that cannot be disposed of in a normal ANC setting. Optimistic: No biohazard waste for disposal.

Disposable strips and other testing supplies could be disposed of using routine methods at primary care clinics.

16

5.15 Target Shelf Life Minimum: For disposable component: 3 months upon opening container at test operating range. No cold chain required. Optimistic: None.

The minimum and optimistic criteria for shelf life will vary depending on whether the test is invasive and requires a reader plus consumables or noninvasive and requires a digital device and possible a sensor/probe. More information is needed to inform these requirements across varying contexts. The shelf life of the HemoCue® (HemoCue AB, Ängelholm, Sweden) is 3 months upon opening container at test operating range with no cold chain requirements. Stakeholder interviews indicate that this is acceptable and aligned with patient volumes in most target settings. A noninvasive test would not have any shelf life restrictions.

17

Product costs and channels to market

Target

Annotations

6.1 Target Cost per Result

Minimum: Less than US$0.75 per test. Includes the consumable cost plus the reader cost per result. Optimistic: To be determined.

Given the test use as part of routine screening at multiple time points during

pregnancy, cost is a critical factor. Expert interviews and global guidance

acknowledges that proposed use may entail high recurrent costs, and

alternatives to a hemoglobinometer may be used if high cost would prohibit

routine and regular screening.1

The estimated cost per result using a digital hemoglobinometer is $0.75

(HemoCue®; HemoCue AB, Ängelholm, Sweden), which, given the recurrent

cost of screening at multiple timepoints, may be too costly for routine use in

ANC.31 Stakeholders interviewed indicated that the cost per result should be in

the $0.02–$0.07 range.32,33 The willingness of manufacturers to meet such low

prices points in a relatively undefined market must also be carefully considered.

The total cost of the test would include the cost of the reader plus any

consumable component. For invasive tests, this would include any disposable

strip or cuvette, and for noninvasive tests, this would include any sensor or

probes needed. More costing and cost-effectiveness data is needed to

understand the minimal and optimistic criteria for test cost. In particular, the

different cost structures between an invasive and noninvasive method should be

better understood.

6.2 Stability Requirements, Storage Conditions, Cold

Chain Requirements

See 5.15 Target Shelf Life.

18

Minimum: See 5.15 Target Shelf Life. Optimistic: See 5.15 Target Shelf Life.

6.3 Channels to Market Minimum: Approved by relevant global bodies (i.e., UNICEF to enable distribution by UNICEF Supply Division). Any consumables must be available through local distributors in each target country to ensure a consistent supply. Optimistic: Same as well as ability to procure and distribute through the Global Financing Facility (GFF).

Once approved, certified, and accepted by UNICEF, it would be the preferred

method, distributed by UNICEF Supply Division. Procurement through GFF.

Consumables must be available locally in order to ensure a consistent supply.

Two core attributes identified as necessary for hemoglobinometer uptake

included user training on test use and maintenance and local availability of

disposable components.11

6.4 Supply, Service, and Support Mechanisms

Minimum: Service and support supplied via distribution channels, either directly from NGOs procuring tests or from their agents/distributors. Optimistic: No service or support required.

Delivery of service and support may come through the product distribution channels. Ideally, the device would not require external service or support for the duration of use. Clear training materials should be made widely available.

19

References

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Experience. Geneva: World Health Organization; 2016. 152 p.

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planning, antenatal and delivery care: cross-sectional survey evidence on levels of coverage and

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International Health. Apr. 2016;21(4):486–503.

3. Yoshida A, Saito K, Ishii K, Azuma I, Sasa H, Furuya K. Assessment of noninvasive, percutaneous

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2014;7:11–16.

4. Skelton VA, Wijayasinghe N, Sharafudeen S, Sange A, Parry NS, Junghans C. Evaluation of point-of-

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Nutrition. Jun. 1999;69(6):1243–1248.

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15. HemoCue. Package Insert for Hb201+ Cuvettes. Ängelholm, Sweden: HemoCue AB; 2016. Available

at https://hemocuepacific.com/blogs/news/103937286-package-insert-for-hb-201-cuvettes.

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hemoglobin measurement tools and their accuracy and reliability when screening for child anemia in

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Change management

Version Key changes from previous version

1.0

First draft of the TPP for point-of-care hemoglobinometers.

1.1

June 29,

2018

PATH edits based on literature review and stakeholder interviews.