Hb Hemoglobin Test Strips (Whole Blood)
Package Insert
REF C131-3011 REF C131-3021 English
For testing hemoglobin (Hb) in human whole blood.
For in vitro diagnostic use only.
The Hb Hemoglobin Test Strips (Whole Blood) are firm plastic strips onto which a multilayer dry reagent is affixed and are intended to
be read on the Missi on
into methemoglobin. This test is for the quantitative determination of hemoglobin (Hb) and calculated hematocrit (Hct) in capillary and
venous whole blood. The test strips are for professional use only.
Hemoglobin is the main component of red blood cells whose main function is to transport oxygen. The determination of hemoglobin
concentration in whole blood is useful in the clinical diagnosis of diseases such as anemia and polycythemia. The measurement
range of the Mission
Erythrocytes in the specimen are lysed to release hemoglobin. The hemoglobin is converted to methemoglobin. The intensity of the
color produced from this reaction is proportional to the hemoglobin concentration. Reference values are listed in the chart below:
Reference ranges may vary between laboratories. Every laboratory should establish its own reference range as needed. 1
Based on the dry weight at the time of impregnation, the concentrations given may vary within manufacturing tolerances.
The performance characteristics of these Hb Hemoglobin Test Strips have been determined in both laboratory and clinical tests. This
test has been developed to be specific for the parameters to be measured with the exception of the interferences listed. Refer to the
Limitations section for detailed information.
• For in vitro diagnostic use on ly.
• The strip should remain in the closed canister until use.
• Do not use after the expiration date.
• Do not touch the reagent area of the strip.
• Discard any discolored or damaged strips.
• All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
• The used strip should be discarded according to local regulations after testing.
• Check the code chip before performing a test. Make sure to use the code chip that is included with the canister of strips. Insert the
code chip into the code chip slot. The code chip slot is located on the right side of the meter.
Store as packaged in the closed canister, either at room temperature or refrigerated (2-30°C). Keep out of direct sunlight. Strips are
stable through the expiration date printed on the canister label. Remove only enough strips for immediate use. Replace cap
immediately and tightly. DO NOT FREEZE. Do not use beyond the expiration date.
Note: Once the canister has been opened, the remaining strips are stable for up to 3 months. Stability may be reduced in high
humidity conditions.
• Acceptable specimens in clude fresh capillary or venous blood, following NCCLS Guideline H4A4 f or capillary blood s peci men’ s collection.
• Fresh capillary or venous blood specimens must be collected and tested immediately.
• Specimens with EDTA or heparin anticoagulants may be used. Preserved specimens must be kept in a closed container and must
be used within 8 hours of collection. Mix stored specimens adequately before testing.
• A Capillary Transfer Tube or pipette should be used to collect capillary specimens for accurate results.
• Test strips • Code chip
• Lancing device
• Latex gloves
Allow the strip, specimen, and/or controls to reach room temperature (15-30ºC) prior to testing. Re fer to the Hb Hemoglobin
Testing System User’s Manual for detailed instructions.
1. Insert the code chip into the meter and code the meter correctly. Refer
to Coding the Meter in the User’s Manual for details. Compare the code
number on the code chip with the code number printed on the test strip
canister label, and ensure the two numbers are identical to avoid
inaccurate results.
2. Remove the strip from the closed canister and use it as soon as
possible. Immediately close the canister tightly after removing the
required number of strip(s).
3. Wait for the meter to flash the strip symbol. Insert the strip completely
into the Strip Channel in the same direction as the arrows printed on the
test strip until the white edge above the black line on the test strip is no
longer visible.
4. Wipe away the first drop of blood. Collect 10 μL of the second drop of
capillary blood using a Capillary Transfer Tube, or pipette. Refer to the
User’s Manual for details. Hold the tube slightly downward and touch
the tip of the Capillary Transfer Tube to the blood drop. Capillary action will automatically draw the sample to the fill line and stop.
Note: Make sure the blood covers the air vent of the tube or it will be hard to squeeze blood out.. Do not squeeze the Capillary
Transfer Tube while collecting specimen.
®
Hb Hemoglobin Meter. The test strips function by lysing erythrocytes and converting the released hemoglobin
®
Hb Hemoglobin Testing System is 4.5 – 25.6 g/dL.
Men 13.0
Women 12.0 – 15.0 g/dL (120 – 150 g/L, 7.4 – 9.3 mmol/L)
Children 11.0 – 14.0 g/dL (110 – 140 g/L, 6.8 – 8.7 mmol/L)
REAGENTS AND PERFORMANCE CHARACTERISTICS
Sodium dexycholate 3% w/w
Sodium nitrite 1.5% w/w
Non-reactive Ingredients 95.5% w/w
• Sterile lancet • Hb m eter • Gauze for puncture site
• Alcohol swab • Capillary Transfer Tubes
INTENDED USE
SUMMARY
PRINCIPLE AND REFERENCE VALUES
– 17.0 g/dL (130 – 170 g/L, 8.1 – 10.5 mmol/L)
gent Composition
Rea
PRECAUTIONS
STORAGE AND STABILITY
SPECIMEN COLLECTION AND PREPARATION
MATERIALS
Materials Provided
Materials Required But Not Provided
DIRECTIONS FOR USE
• Package insert
or
5. While the meter is flashing the blood drop symbol, align the tip of the Capillary Transfer Tube with the Specimen Application Area
of the strip to apply the blood (10 μL). 3 dashed lines will appear on the meter to show the test is in progress.
6. Read the results on the screen after 15 seconds. Refer to Testing in the User’s Manual for detailed test procedures.
The Hb Hemoglobin Meter automatically measures hemoglobin concentration. In the event of unexpected or questionable results, the
following steps are recommended:
• Confirm that the strips have been used within the expiration date printed on the canister label.
• Compare results to controls with known levels and repeat the test using a new strip.
• If the problem persists, discontinue using the strips immediately and contact your local distributor.
Ten replicate assays were drawn from three strip lots and tested on the Hemoglobin Meter (y), using ten concentration levels of
heparin preserved venous blood specimens. Several Hb Hemoglobin Meters were used to perform tests at each concentration (n=5).
The same specimens were also tested using a market leader analyzer (x). Linearity results are presented below:
100 replicate assays were tested using the Hb Hemoglobin Meter. Fresh heparin preserved venous blood specimens at three
concentration levels were used with three strip lots, producing the following within-run precision and total precision estimates.
Within-run precision using whole blood specimens statistical analysis gives the mean, standard deviations (SD), and coefficients of
variation (CV%) listed below:
Total precision is listed below:
The Hb Hemoglobin meter (y) and strips were used by a trained technician to test heparin preserved venous blood specimens from
159 participants. The same specimens were analyzed using a market leader hemoglobin analyzer (x). The same testing was
performed using capillary blood specimens from 51 participants. The results are compared below:
For best results, performance of test strips should be confirmed by testing known specimens/controls whenever a new test is
performed or whenever a new canister is first opened. Each laborato ry should establish its own goals for adequate standards of
performance. Contact your local distributor for information on specific controls for this product.
The following substances do not interfere with test results:
High concentrations of triglycerides and salicylic acid can lead to low Hb measurements. High concentration of bilirubin can lead to
high hb measurement. Anticoagulants, such as heparin and EDTA, are recommended for use with venous whole blood. Do not use
anticoagulants such as iodoacetate, sodium citrate or those containing fluoride. Do not use plasma or serum with the Hb Hemoglobin
Testing System.
1. Henry, J. B. Clinical Diagnosis and Management by Laboratory Methods. 15-290, 2001.
Strip Lot Linearity equation r
Strip Lot 1 y = 0.9814x + 0.2168 0.9990
Strip Lot 2 y = 1.0094x + 0.0071 0.9990
Strip Lot 3 y = 0.9937x + 0.3093 0.9991
Level I (n=100) Level II (n=100) Level III (n=100)
Precision Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lo t 3
Mean (g/dL) 9.6 9.9 9.7 13.6 14.0 13.8 17.5 17.9 17.8
SD (g/dL) or %CV 0.21 0.20 0.24 1.40% 1.80% 1.30% 1.30% 1.50% 1.4 0%
Test level Level I (n=300) Level II (n=300) Level III (n=300)
Mean (g/dL） 9.7 13.8 17.7
SD (g/dL) or %CV 0.26 2.0% 1.7%
Specimen Slope Intercept R N
Venous blood 0.9582 0.5673 0.992 15 9
Capillary blood 1.0006 0.026 0.993 51
Substance
Acetaminophen 200 mg/dl Cholesterol 5 g/l
Ascorbic Acid 60 mg/dl Tetracycline 15 mg/dl
Creatinine 50 md/l Urea 2.574 g/l
Ibuprofen 500 mg/dl Uric Acid 235 mg/l
Dopamine 0.9 mg/l Methyldopa 15 mg/l
INTERPRETATION OF RESULTS
PERFORMANCE CHARACTERISTICS
Linearity
Reproducibility and Precision
Accuracy
QUALITY CONTROL
LIMITATIONS
Amount Substance Amount
BIBLIOGRAPHY
Index of Symbols
Consult instruction s for use
For in vitro diagnostic use only
Store between 2-30°C
Contents sufficient for <n> tests
ACON Laboratories, Inc.
10125 Mesa Rim Road
San Diego, CA 92121, USA
Use by
Lot Number
Manufacturer
Authorized
Representative
Schiffgraben 4 1
30175 Hannover, Germany
MDSS GmbH
Code Number
Control Range
Catalog #
REF
Do not reuse
Number: 1150525708
Effective date: 2015-
04-15
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