EKF Diagnostics DiaSpect Tm User manual

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DiaSpect Tm User Manual
Table of Contents
1. Intended Use..............................................................................2
2. Principles of the Procedure ...........................................................2
3. The DiaSpect Tm system ..............................................................3
3.1 DiaSpect Tm Analyzer .........................................................3
3.2 DiaSpect Tm Cuvettes .........................................................3
4. Control Material ..........................................................................4
5. Important Safety Instructions and Notes on Radio Interference ........5
6. Installation and Operation............................................................7
6.1 Charging ...........................................................................8
6.2 Data Transfer.....................................................................9
6.3 Cleaning and Disinfection.....................................................9
6.4 Quality Control ..................................................................10
6.5 Disposal ............................................................................10
6.6 Service and Maintenance.....................................................11
7. Specimen Collection and Preparation ............................................12
7.1 Capillary Sampling..............................................................12
7.2 Venous Sampling................................................................14
7.3 Control Sampling................................................................15
8. Measuring ..................................................................................16
9. Troubleshooting Guide................................................................. 17
10. Expected Values .........................................................................18
11. Performance Characteristics .........................................................18
12. Technical Specifications ............................................................... 21
13. Limitations .................................................................................22
14. References .................................................................................23
15. Consumables..............................................................................24
16. Spare parts and Accessories.........................................................24
17. Symbols Used.............................................................................25

DiaSpect Tm User Manual
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1. Intended Use
The DiaSpect Tm system is intended for the in vitro quantitative measurement of
total hemoglobin in non-anticoagulated capillary whole blood and venous whole
blood drawn in K2-EDTA or lithium heparin tubes in point-of-care settings and in
non-anticoagulated capillary whole blood and venous whole blood drawn in K2-
EDTA tubes in blood bank settings. The DiaSpect Tm system consists of the
DiaSpect Tm analyzer and specifically designed disposable cuvettes. The DiaSpect
Tm analyzer is only to be used with DiaSpect Tm Cuvettes.
Caution: Federal law restricts this device for sale by or on the order of a
physician or other licensed practitioner (Rx only).
CLIA Complexity for whole blood: Waived
Laboratories with a Certificate of Waiver must follow the manufacturer’s
instructions for performing the test, or the test will no longer be considered CLIA
waived.
2. Principles of the Procedure
Based on a photometric principle, the DiaSpect Tm system utilizes a broad-
spectrum, multi-chromatic sensor with compensation for turbidity and scattering
which measures the absorbance of whole blood over a wide spectral range. The
light path length through the cuvette cavity, in combination with the DiaSpect Tm
analyzer, determines the exactness of the hemoglobin measurement. The
hemoglobin concentration is calculated from the measured absorbance at multiple
wavelengths.
The cuvettes do not contain any reagent. The system is calibrated against the
hemoglobincyanide (HiCN) method, the international reference method for the
determination of hemoglobin concentration in blood as described in NCCLS/CLSI
H15-A3 and ICSH standard 1995.1,2
The DiaSpect Tm analyzer is factory calibrated and requires no further calibration.

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DiaSpect Tm User Manual
3. The DiaSpect Tm system
3.1 DiaSpect Tm analyzer
Upon delivery, open the carton on a stable surface, remove the instrument and
the accessories, and check that all the components are included and undamaged.
A comprehensive list (with item numbers) of all parts for the DiaSpect Tm system
can be found in sections 15 and 16.
The DiaSpect Tm analyzer can be stored at 0 to 50 °C (32 to 122 °F).
Temperatures of -30 to 70 °C (-22 to 158 °F) are temporarily permitted during
transport (24 hours max.).
The operating temperature of the instrument is 10 to 42 °C (50 to 107 °F). Allow
the analyzer to reach ambient temperature before use.
1. DiaSpect Tm
analyzer
2. User Manual
3. Power supply, adapter
plug and USB cable
3.2 DiaSpect Tm Cuvettes
Cuvettes are ready for use upon removal from the package. A sample volume of
10 µL is required to ensure proper filling of the DiaSpect Tm Cuvette. The cuvette
serves as sample collector and measuring cuvette at the same time. The blood
sample is drawn into the cavity by capillary force.

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Refer to the product label and package insert of the DiaSpect Tm Cuvettes for
information on storage and expiry. Unused cuvettes should be stored in their
original bag.
DiaSpect Tm Cuvettes Cuvettes in foil bag
4. Control Material
DiaSpect Controls HBT are available to facilitate compliance with local, state
and/or federal regulations or accreditation requirements.
The DiaSpect Control HBT is produced in three concentrations that correspond to
three known levels of human hemoglobin. Refer to the product label and package
insert of the DiaSpect Control HBT for further information on storage and expiry.
Contents: 1.9 mL per vial, 3 vials per package
Package configurations of DiaSpect Control HBT
DiaSpect
Control HBT1
3 x DiaSpect Control HBT-Low
DiaSpect
Control HBT2
3 x DiaSpect Control HBT-Medium
DiaSpect
Control HBT3
3 x DiaSpect Control HBT-High
DiaSpect
Control HBT4
1 x DiaSpect Control HBT-Low
1 x DiaSpect Control HBT-Medium
1 x DiaSpect Control HBT-High

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DiaSpect Tm User Manual
5. Important Safety Instructions and Notes on Radio
Interference
DiaSpect Tm analyzer
Avoid strong mechanical shocks to the analyzer.
Do not expose the analyzer to liquids.
After storage or transport, allow the analyzer to acclimate to its operating
temperature of 10 to 42 °C (50 to 107 °F) to prevent condensation damage.
Do not place the DiaSpect Tm analyzer in direct sunlight or near a heat source.
Do not place the DiaSpect Tm analyzer in, or next to, wet areas such as sinks
or wash basins.
Do not insert anything other than the USB cable into the socket in the back of
the analyzer.
Power Supply
Only use the power supply provided with the instrument. Do not expose the
power supply to liquids.
Do not place the power supply near heat sources or expose it to direct sunlight.
Do not use the power supply if its cable has a visible kink in it or becomes
damaged.
Blood
Always handle blood as potentially infectious. Use gloves and avoid direct skin or
mucous membrane contact with donated blood, blood specimens, blood from
transfer pipettes, DIFF-SAFE®blood dispensers, blood from filled cuvettes or
blood on the cuvette holder / DiaSpect Tm analyzer. Dispose of contaminated
items in proper hazardous waste containers.

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FCC statement
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
Notes on radio interference
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may
cause harmful. Interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which
can be determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
Consult the dealer.
Caution
Changes or modifications not expressly approved by the manufacturer could void
the user’s authority to operate the equipment.
RF exposure info
The equipment complies with FCC RF exposure limits set forth for an uncontrolled
environment.
Radio equipment
Frequency Bands
Radio Frequency Power
Bluetooth®Low Energy
2.402 - 2.480 GHz
<1 mW

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DiaSpect Tm User Manual
6. Installation and Operation
Only healthcare professionals may use the DiaSpect Tm analyzer.
Please read this entire manual before using the analyzer for the first time. Follow
the instructions carefully when performing the test as not doing so may result in
inaccurate test results.
The DiaSpect Tm analyzer comes ready for use. No installation procedure is
necessary. The display is always ON. The analyzer does not have an ON/OFF
switch. When not in use, the analyzer remains in a low power mode.
The DiaSpect Tm analyzer may be used as a handheld device.
Understanding the DiaSpect Tm Display
Battery symbol
Shows battery charge status
Blinking:
Battery low
Hemoglobin value
Cuvette symbol
Visible:
Insert cuvette
Blinking:
Remove cuvette
Flash Symbol
Visible:
Connected to
power
Unit of measure
Checkmark
Shows valid reading
and passed self-check
Antenna Pole
Shows RF connection
status and signal
strength (only with
activated Bluetooth®
option)
USB symbol
Shows USB
connection status
Visible:
Connected to host
Blinking:
Data transfer

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6.1 Charging
The DiaSpect Tm analyzer has a built-in rechargeable battery. The battery can be
recharged by connecting to a power supply or to a computer via a USB cable. A
USB cable and a power supply for charging the battery are supplied.
Charging by power supply:
1. Connect the USB cable to the analyzer.
2. Check that the adapter plug is connected to the power supply.
3. Connect the USB cable to the power supply and plug the power
supply into a power outlet.
Charging by power supply
Charging by computer:
1. Connect the USB cable to the analyzer.
2. Connect the USB cable to the USB port of a computer.
Charging by computer
The battery symbol in the display shows the current charging state.
The flash symbol indicates that the instrument is connected to power.
Leaving the instrument connected to a power source when the battery is fully
charged will neither overcharge the battery nor decrease its lifespan.

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DiaSpect Tm User Manual
A fully charged battery lasts up to 40 days / 10,000 tests of continuous use.
The battery must be charged when the last status bar is shown, at the latest
when E07 is indicated on the display, see Troubleshooting Guide (section 9).
Fully charge the battery after 9 months, whether or not the instrument has
been in use.
6.2 Data Transfer
The DiaSpect Tm analyzer comes with USB 2.0 and an optional Bluetooth®
function.
For additional information on data transfer, please contact the manufacturer.
6.3 Cleaning and Disinfection
1. Pull the backside of the cuvette holder slightly towards you and lift up.
2. Using a swab, clean the cuvette holder with cold water or a mild detergent,
followed by disinfectant. Dry thoroughly.
3. Re-insert the dry cuvette holder by pressing down until you feel a “click”.
4. Clean device with cold water or mild detergent, followed by disinfectant.
To disinfect the instrument, use conventional solvent-free surface disinfectants or
PDI Super Sani-Cloth®Germicidal Disposable Wipes and follow labeling directions.
Do not spray the instrument when cleaning, as this will damage the
instrument!
Only use wipes lightly dampened in water/detergent/disinfectant for cleaning and
disinfection.

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6.4 Quality Control
The DiaSpect Tm system is factory calibrated and requires no further calibration.
The DiaSpect Tm analyzer will perform an automatic self-check after each
measurement. Passing the self-check verifies the measurement performance and
is indicated by a check-mark. An error code is displayed if the self-check fails and
the analyzer will cease measuring, so there is no risk of an incorrect result being
displayed.
DiaSpect Controls HBT are available to facilitate compliance with local, state
and/or federal regulations or accreditation requirements.
Run the controls as described in section 7.3. Control values must fall within the
ranges stated on the vial labels. If controls are not in range, repeat with a new
cuvette. If values are still out of range, contact Technical Support at
1-800-531-5535.
6.5 Disposal
Used Cuvettes
Dispose of used cuvettes in a container for potentially infectious waste. Consult
local environmental authorities for adequate disposal.
DiaSpect Tm Analyzer
The lithium-ion battery in the DiaSpect Tm analyzer has to be disposed of
separately. For disposal of the battery, analyzer and power supply, follow the
relevant regional or local waste disposal regulations. If you require the
manufacturer to dispose of the instrument and its components, please return
them to EKF Diagnostics (see section 6.6). Confirmation of appropriate
disinfection of the instrument should be included in the shipment.
DiaSpect Control HBT
For disposal of the control material refer to the respective instructions for use.

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DiaSpect Tm User Manual
6.6 Service and Maintenance
The DiaSpect Tm analyzer does not require maintenance. For cleaning, see 6.3.
If damaged, the cuvette holder, USB cable, adaptor plug and the power supply
can be replaced by the user.
Should the DiaSpect Tm analyzer fail to function as intended, try to solve the
issue by using the Troubleshooting Guide, (Section 9). If this is not possible,
return the DiaSpect Tm analyzer to EKF Diagnostics or your local distributor.
Never open the analyzer or the power supply.
Any repairs which may be necessary must be carried out by the manufacturer or
by authorized personnel only.
Failure to follow the specific instructions for use may result in warranty services
offered by the manufacturer being restricted.
For Technical Support, please contact:
EKF Diagnostics, Inc.
1261 North Main Street
Boerne, TX 78006
USA
Phone: [phone]
Email: [email protected]
www.ekfusa.com

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7. Specimen Collection and Preparation for Analysis
Capillary blood or venous whole blood containing K2-EDTA or lithium heparin
anticoagulant may be used.
7.1. Capillary Sampling
With gloved hands, take a DiaSpect Tm Cuvette out of the foil bag and close the
bag. Make sure the hand is warm and relaxed. Use the middle or ring finger for
sampling. Avoid fingers with rings on.
1. Disinfect and dry the puncture site.
2. Gently massage the finger towards the tip to increase blood flow. Avoid going
past the first knuckle.
3. Make the incision on the upward-facing side of the fingertip, so that the blood
drop sits on top of the finger, to facilitate filling of the cuvette.
4. Apply light pressure towards the fingertip (but not past the first knuckle) until
a blood drop appears. Wipe away the first 3 drops and make sure there is a
free blood flow before filling the cuvette with the fourth drop.
5. Be sure to have a sufficient sized blood drop to fill the cuvette. Fill the
cuvette completely by touching the corner of the cuvette to the blood drop.
Do not refill the cuvette. If a cuvette cannot be filled in one continuous
process, or if the cuvette contains air bubbles, discard the cuvette and use a
new one, repeating steps 4 and 5.
6. Gently wipe off the excess blood on the outside of the cuvette with a gauze
pad. Be sure to gently wipe both sides. Do not wipe too close to the open end
as this can draw blood out of the cuvette.

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DiaSpect Tm User Manual
Repeat Testing
Be careful to apply the procedure described in step 1-6 correctly when collecting
capillary blood for hemoglobin measurements.
The most common causes for erroneous results are choice of an unsuitable size
or type of lancet, incorrect capillary sampling technique, restricted capillary blood
flow, or the presence of tissue fluid in the sample after pressing the fingertip too
hard. These factors commonly affect the result.
Confirmation of an unexpected or unacceptable result can exclude sampling
mistakes as the cause. As the DiaSpect method is very fast, this confirmatory test
can probably be done using the same incision. Further drops following the 4th drop
may be used for testing as long as there is still a free flow of blood.
If the blood flow has decreased or stopped, another incision should be made for
the confirming sample. Repeat the procedure described in steps 1-6 and record
all results from repeated sampling, including relevant information about the
reason for retesting.

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7.2 Venous Sampling
If a venous sample cannot be run immediately, it may be refrigerated up to 72
hours. If the blood is refrigerated, then the blood should be allowed to reach room
temperature before testing. K2-EDTA or lithium heparin tubes may be used.
With gloved hands, take a DiaSpect Tm Cuvette out of the foil bag and close the
bag.
1. Make sure the sample is at room temperature before testing. Mix the tube by
gentle inversion at least 8 times.
2. Place a drop of blood on to a hydrophobic surface (e.g. Parafilm) using a
commercially available transfer pipette or DIFF-SAFE®Blood Dispenser.
3. Fill the cuvette completely by touching the corner of the cuvette to the blood
drop. Do not refill the cuvette. If a cuvette cannot be filled in one continuous
process, or if the cuvette contains air bubbles, discard the cuvette and use a
new one, repeating steps 2 and 3.
4. Gently wipe off the excess blood on the outside of the cuvette with a gauze
pad. Be sure to gently wipe both sides. Do not wipe too close to the open end
as this can draw blood out of the cuvette.

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DiaSpect Tm User Manual
7.3 Control Sampling
1. The DiaSpect Tm system can be verified by use of DiaSpect Control HBT.
If stored refrigerated, allow the control solution to reach room temperature
first.
With gloved hands, take a DiaSpect Tm Cuvette out of the foil bag and close
the bag.
Mix the control solution by gentle inversion 5 times immediately before
sampling. Open the vial and discard the first drop.
2. Dispense a second drop of the control solution on to a hydrophobic surface
(e.g. Parafilm).
Fill the cuvette completely by touching the corner of the cuvette to the drop.
Do not refill the cuvette. If a cuvette cannot be filled in one continuous
process, or if the cuvette contains air bubbles, discard the cuvette and use a
new one with a new drop of control solution.
3. Gently wipe off the excess control solution on the outside of the cuvette with
a gauze pad. Be sure to gently wipe both sides. Do not wipe too close to the
open end as this can draw control solution out of the cuvette.

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8. Measuring
1. Insert the filled cuvette in the cuvette holder.
2. Press down gently until you feel a “click” and hold in position until the result
appears on the screen. Pull the cuvette out of the DiaSpect Tm quickly.
3. Dispose of the used cuvette in a container for potentially infectious waste.
Record the test result as soon as the checkmark is shown.
4. The result will remain on the display until replaced by the next measurement.
To erase the latest result, press down on the empty cuvette holder.
Use only completely filled cuvettes for measuring. A filled cuvette should be
analyzed within 1 minute after filling. A filled cuvette should be kept in a horizontal
position until measurement.
If the DiaSpect Tm analyzer has been out of use for a couple of hours, an error
code may appear after the first measurement. Remove the filled cuvette, make
a “blank” measurement by pressing down the empty cuvette holder and then
reinsert the filled cuvette for measurement.

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DiaSpect Tm User Manual
9. Troubleshooting Guide
Symptom
Possible Cause
Correction
Unexpectedly
high / low result
Improper sample
Repeat the sampling. Make sure that
the sampling is done correctly.
See 7.1 to 7.3 for more information.
Error E01
Calibration lost
Contact Technical Support at
1-800-531-5535.
Error E02
Sensor read error
Repeat measurement with the same
cuvette. If error persists, contact
Technical Support at 1-800-531-5535.
Error E03
Self-check failed
E03 may be displayed if a filled cuvette
is left in the cuvette holder, or was
removed too slowly. In order to reset
the self-check function, press down on
the empty cuvette holder. The screen
should display “---” and a “√”.
If error persists, contact Technical
Support at 1-800-531-5535.
Error E04
Light source too dark
Remove cuvette from cuvette holder.
Press cuvette holder several times until
the screen reads “---” and a “√”
appears. If error persists, contact
Technical Support at 1-800-531-5535.
Error E05
Light source too bright
Remove cuvette from cuvette holder.
Press cuvette holder several times until
the screen reads “---” and a “√”
appears. If error persists, contact
Technical Support at 1-800-531-5535.
Error E07
Battery too low to
perform measurements
Recharge the battery.
Display blank,
measuring not
possible
Battery completely
discharged
To recharge the battery, connect with a
power outlet or computer and charge for a
minimum of 4 hours.
If recharging fails, contact Technical
Support at 1-800-531-5535.

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10. Expected Values3 - 8
The unit of measure for the hemoglobin value is g/dL. The following hemoglobin
values are considered normal:
Population
Age Range
Cited Reference Range*
Adult Male
≥ 22 years
13.0 –17.0 g/dL
Adult Female
≥ 22 years
12.0 –15.0 g/dL
Child/Adolescent
> 2 years to 21 years
11.0 –15.5 g/dL
Infant
1 month to 2 years
9.4 –16.5 g/dL
* Reference ranges are based on medically accepted published reference ranges
(Dacie and Lewis, Practical Haematology, Twelfth Edition, Elsevier Limited 2017).
These ranges are for general guidance only. Each laboratory should establish its
own normal range.
11. Performance Characteristics
a) Within Run and Total Precision
Repeatability and overall reproducibility of three samples was tested over 20
days.
b) Accuracy, Point-of-Care
The results of the comparison studies between the DiaSpect Tm and the predicate
device performed at the point-of-care are summarized in the following table. The
study was performed across four external sites.
Sample
Type
N
Min
Max
Slope
Correlation
Coefficient (r)
EDTA
344
4.1 g/dL
24.5 g/dL
0.9858
0.986
Li-heparin
120
10.4 g/dL
20.0 g/dL
0.9834
0.987
Capillary
363
8.5 g/dL
20.1 g/dL
0.9903
0.963
Sample
Concentration
Within-Run (SD, %CV)
Total (SD, %CV)
Low
7.99 g/dL
(0.085, 1.06%)
(0.11, 1.38%)
Medium
12.58 g/dL
(0.11, 0.88%)
(0.14, 1.09%)
High
15.82 g/dL
(0.15, 0.92%)
(0.22, 1.41%)

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DiaSpect Tm User Manual
DiaSpect Tm has not been evaluated for capillary samples with hemoglobin values
below 8.5 g/dL as such samples are very rarely seen in the primary care setting.
It is recommended that patients showing a capillary hemoglobin of less than 8.5
g/dL are referred to a confirmatory laboratory test.
c) Accuracy, Blood Donation Centers
A method comparison of 150 capillary and 147 venous samples was conducted at
two blood bank settings, giving the following results:
Sample
Type
N
DiaSpect Tm
Minimum
DiaSpect Tm
Maximum
Hb301
Minimum
Hb301
Maximum
K2-EDTA
147
10.4 g/dL
22.0 g/dL
11.1 g/dL
20.7 g/dL
Capillary
150
10.5 g/dL
20.6 g/dL
10.7 g/dL
20.7 g/dL
DiaSpect Tm vs HemoCue Hb 301 (linear regression)
Matrix
N
Slope (95% CI)
Intercept (95% CI)
r
Capillary
150
0.9541 (0.9134~0.9948)
0.2619 (-0.3496~0.8733 )
0.967
Venous
147
1.1465 (1.1068~1.1863)
-2.5299 (-3.4183~-2.1122)
0.978
DiaSpect Tm vs HemoCue Hb 301 (Passing-Bablok regression)
Matrix
N
Slope (95% CI)
Intercept (95% CI)
r
Capillary
150
1.000 (0.9512~1.032)
-0.45 (-1.011~0.2805)
0.967
Venous
147
1.140 (1.100~1.179)
-2.477 (-3.067~-1.895
0.978
The bias of the DiaSpect Tm at the hemoglobin deferral levels for male and female
donors was calculated from the regression curves using the Hb 301 as the
reference method.
Donor Cutoff, Hb 301
DiaSpect Tm Capillary
DiaSpect Tm Venous
Hb Level
% Bias
Hb Level
% Bias
Adult Female, 12.5 g/dL
12.2 g/dL
-2.4%
11.8
-5.6%
Adult Male, 13 g/dL
12.7 g/dL
-2.3%
12.4
-4.8%
Using the HemoCue Hb301 as the reference method, the agreements for blood
donor eligibility are as follows:

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Capillary All Donors
Hb 301 ≥Cutoff
Hb 301 <Cutoff
DiaSpect Tm ≥Cutoff
127
2
DiaSpect Tm <Cutoff
7
14
Agreement (Score 95% CI)
Accept = 127/134 = 94.8% (89.6~97.4%)
Reject = 14/16 = 87.5% (64.0~96.5%)
Overall = 141/150 = 94.0% (89.0~96.8%)
Venous All Donors
Hb 301 ≥Cutoff
Hb 301 <Cutoff
DiaSpect Tm ≥Cutoff
120
1
DiaSpect Tm <Cutoff
13
13
Agreement (Score 95% CI)
Accept = 120/133 = 90.2% (84.0~94.2%)
Reject = 13/14 = 92.9% (68.5~98.7%)
Overall = 133/147 = 90.5% (84.6~94.2%)
The discordance observed was investigated by comparison to a laboratory
reference method. In a separate study, 100 capillary and 100 venous samples
were tested with the DiaSpect Tm, the HemoCue Hb 301 and the Sysmex XP-300.
The DiaSpect Tm was found to be substantially equivalent to the Sysmex XP-300
(calibrated to the hemiglobincyanide method, HiCN), while the HemoCue Hb 301
consistently provided results that were higher by approximately 0.6 g/dL. These
results are summarized below.
The bias of the DiaSpect Tm at donor eligibility cutoffs was calculated from the
regression curves using the Sysmex XP-300 as the reference method.
Donor Cutoff, XP-300
DiaSpect Tm Capillary
DiaSpect Tm Venous
Hb Level
% Bias
Hb Level
% Bias
Adult Female, 12.5 g/dL
12.56
0.5%
12.53
0.2%
Adult Male, 13 g/dL
13.05
0.4%
13.07
0.7%
The positive bias of the Hb 301 at donor eligibility cutoffs was calculated using
the Sysmex XP-300 as the reference method. The positive bias of the Hb 301 is
consistent with its higher acceptance rate of donors near the eligibility cutoff, and
is supported by the literature.9,10
Donor Cutoff, XP-300
Hb 301 Capillary
Hb 301 Venous
Hb Level
% Bias
Hb Level
% Bias
Adult Female, 12.5 g/dL
13.12
5.0%
13.03
4.2%
Adult Male, 13 g/dL
13.62
4.8%
13.55
4.2%