EKF Diagnostics STAT-Site MHigh User Manual

TEST PROCEDURE

The STAT-Site® M
insert and in the STAT-Site

Before You Test: Read the STAT-Site® M

Hgb

Test procedure is detailed in this

® MHgb

Meter User’s Guide.

Hgb

Meter
User’s Guide for complete information on meter setup,
maintenance and display messages.

Materials Provided

• STAT-Site® M

• CODE Key

Additional Materials Needed

• Latex Gloves

• Lancets for capillary blood collection

• Biohazardous waste container

• Alcohol swabs and gauze for cleaning puncture site

• STAT-Site® Hemoglobin Controls, Cat. No. 503000

• STAT-Site® M

Hgb

T est Cards

Hgb

Meter (Catalog #900900).

Display

This is where the Test Results, Symbols and
Codes, and simple Messages that guide you

through the procedure are displayed.

On/Off
Button

Used to turn the
meter off and on.

Up Button

Used to access
memory, and select
options.

Test Card
Platform

Can be removed to
provide access to
battery, CODE Key,
and to clean.

Test Card
Platform Tab

Helps you remove the Test
Card Platform.

Press to turn on power. To conserve battery
power, the meter will automatically shut off if left
idle for more than 2 minutes.

pg 2

Figure 1

Test Card Holder

This is where the STAT-Site® M
Test Cards are inserted.

Down
Button

Used to select options.

Hgb

STEP 1. CODE the Meter

If the CODE number on the
display matches the CODE
number of the Test Card that
you are using, GO TO STEP 2
(see Figure 2).

If no CODE number or a CODE

Figure 2

number different from the CODE of the Test Card that
you are using is displayed on the screen, remove the Test
Card Platform by gently pushing up on the tab at the
bottom of the Test Card Platform (see Figure 1).

Insert the appropriate CODE Key in the opening marked
with an arrow (see Figure 4).

When the CODE Key has been correctly inserted, the
meter will display “CODE,” the coded TEST NAME
(i.e., Hgb), and the CODE number.

You may leave the CODE Key in place and replace the
Test Card Platform by lining up the top edge (see Figure

3), sliding up, and pressing into place.

STEP 2. Insert the Test Card

The flashing Test Card symbol indicates that you
should insert the Test Card. Insert a STAT-Site

® MHgb

Test Card with a CODE number that matches the CODE
displayed on the screen at power on.

Slide the edges of the Test Card under the Guide tabs on
the Test Card Holder. It is important that you insert
the card fully (see Figure 5) to the back. You will feel
and hear the Test Card “lock” into place.

When the display shows the Test Type (i.e. Hgb), an
unblinking Test Card symbol , and a Flashing Drop
symbol , it is time to apply the sample (see Figure 6).

About Obtaining The Fingerstick Sample

• W ashing hands under warm water greatly increases blood flow and

should help to relax the patient.

• The fingerstick should provide a free-flowing drop of blood

without squeezing the fingertip.

• See Page 1 of this insert for additional information on specimen

collection and preparation.

STEP 3. Apply the Sample

Position the drop of blood directly over the center of the
Test Card. Carefully lay the drop of blood on the center
of the Test Card (see Figure 7). If desired, a Transfer
Tube (Catalog #202012) or a device capable of deliver­ing approximately 12µL of blood can be used to collect
and apply the sample (see Figure 8) (needed if sample is
not a large hanging drop applied directly from a finger­stick). After applying the sample to the center of the

Test Card, the countdown to test result will begin.
The Test may finish before reaching zero.

CODE THE METER.

Figure3

Figure 4

INSERT THE TEST CARD.

Figure 5

Figure 6

APPLY THE SAMPLE.

Figure 7

T

EST RESULT

When the test is completed, the final result is displayed along
with the test type and appropriate units (g/dL or mmol/L). The
STAT-Site® M

Hgb

Test provides a direct reading of hemoglobin
concentration in whole blood between 6 and 21 g/dL. Values
below or above this range will be reported as <Lo> or <Hi>
respectively.

Record your result and remove the Test Card. Remove test
card and inspect the bottom of card to confirm even color
development. T o remove the Test Card, lift very slightly as you
slide the Test Card out of the meter. Dispose of the Test Card
properly. Note: see meter User’s Guide for instructions on

setting up units to display.

U

SING MEMORY

The meter will shut off automatically after two minutes of
inactivity . To retrieve the last result from meter memory:

1) Remove the used Test Card.

2) Press the On/Off button to turn the meter on.

3) Press and hold the S Up button to display the last result.

4) Press the On/Off button to turn the meter of f.

Figure 8
(Optional­see Step 3)

DISPLA Y MESSAGES

(For more information see the meter User’s Guide.)

Lo Result is less than (<) 6 mg/dL.
Hi Result is greater than (>) 21 mg/dL.
E-1 Room Temperature is outside of operating range
E-2 Too much sample. Repeat test with new Card.
E-3 Not enough sample. Repeat test with new Card.
E-4 Meter Error Clean meter and retest.
E-5 Card Error Use new card and try again.
E-6 Calibration Error Call T echnical Service.
E-8 CODE Key Error Call Technical Service.

QUALITY CONTROL

T o assure consistent performance of your STAT -Site® M
System, it is recommended that control material be assayed
according to the established quality assurance guidelines for
your facility. For this purpose, we recommend STAT -Site
Hemoglobin Controls, Ref. No. 503000. External controls
should be tested with each new lot or shipment of test cards,
once for each test kit, and as otherwise required by your
laboratory's standard GLP quality control procedures.

Process the controls as you would a patient specimen.
Always test control material when you first use your meter or

if you drop your analyzer, or if there is any indication the Test
System is not functioning properly.

Replicate testing is recommended to ensure that good tech­nique has been achieved. If results with the quality control
material do not fall within the expected range, and the reason
cannot be identified, consult the Technical Assistance section
of the ST AT-Site® M

Hgb

User’s Guide before calling Technical

Service.

LIMITATIONS

• For in vitro diagnostic use.

• Do not use with serum or plasma.

• Fetal, newborn, or variant hemoglobin samples have not

been evaluated with ST AT-Site® M
as 3 weeks old were tested and included in the study .

Hgb

. Children as young

• The performance characteristics of arterial blood have not

been determined.

EXPECTED RESULTS

Different blood hemoglobin values have been reported in the
literature
Adult Males 13-18 g/dL
Adult Females 11-14 g/dL
Infants (postnatal) 10-14 g/dL
Children (2 yrs.-teenage) Gradual increase from

Due to the wide range of conditions (dietary, geographical,
smoking, exercise, recumbency , etc.) which affect reference
values
own expected ranges.

(2,3,4,5)

.

infant to adult levels.

(6)

, it is recommended that each laboratory establish its

Hgb

®

pg 3

PERFORMANCE CHARACTERISTICS

1. Linearity - Linearity was established over the range 5.6 to

20.6 g/dL with venous blood using NCCLS EP6-P guidelines.
The linearity regression line is:
y = 1.03 + 0.08, R = 0.9968.

Stat-Site M HemoSite Linearity

23
21
19
17
15
13
11

9
7
5

Observed conc (g/dL)

5 7 9 11131517192123

Expected conc (g/dL)

2. Within Run Precision - Precision studies with the STAT ­Site® M

Hgb

method using whole blood samples yielded the
following mean values, standard deviations (SD), and coeffi­cients of variation (CV%). Values are for testing of 20
replicates on each of four meters (n=80).

Whole Blood Sample Mean SD CV% n

8.8 g/dL 9.1 0.3 3.5 80

14.3 g/dL 14.1 0.7 4.7 80

17.1 g/dL 16.9 0.8 4.9 80

3. Total Precision –
T otal precision studies were conducted with four instruments
over 20 days using 2 levels of a whole blood control solution
per NCCLS EP5-T2 guidelines. A total of 80 tests were run on
each instrument. The resulting total precision estimate ranges
over four meters are presented in the following table.

Sample Mean SD Range CV% Range n
Low Control 9.9 0.28 - 0.41 2.9 - 4.2 80
Normal Control 13.0 0.37 - 0.55 2.9 - 4.2 80

4. Accuracy -

The ST AT-Site M

Hgb

system was evaluated at three clinical sites
with a patient population consisting of adults, children, and
infants.

The correlation obtained between ST AT-Site M

Hgb

system

results and the reference method for venous samples was:
N = 103; y = 1.00x – 0.84; R = 0.96.
The correlation obtained between ST AT-Site M

Hgb

system
results for capillary samples (transfer tube and directly applied
samples used) and the reference method (venous for adults,
capillary samples for children and infants) was: N = 236; y =

0.98X + 0.16; R = 0.93.

5. Interferences -

Triglycerides (1,005 mg/dL) and bilirubin (20 mg/dL) do not
interfere with the ST AT-Site® M

pg 4

Hgb

T est.

BIBLIOGRAPHY

1. Vanzetti Giulio. An azide-methemoglobin method for hemoglobin determination in
blood. J Lab Clin Med 1966; 67: 116 - 26.

2. Fandek N, Moreau D, Newell K C, Ofner A, eds. Clinical Laboratory Tests - Values
and Implications. 2nd ed. Springhouse: Springhouse Corporation, 1995: 328pp.

3. DeMott Wayne R, Tilzer Lowell L, Hematology. In: Jacobs DS, DeMott WR,
Finley PR, Horvat RT, Kasten Jr BL, Tilzer LL, eds. Laboratory Test Handbook.
Hudson: Lexi-Comp, 1992: 517-626.

4. Wallach J. eds. Interpretation of Diagnostic Tests - A Synopsis of Laboratory
Medicine, 4th ed. Boston/Toronto: Little Brown and Co. 1986: 6pp.

5. Painter Pennell C, Cope June Y, Smith Jane L, Appendix. In: Burtis CA,
Ashwood ER, eds. Tietz Textbook of Clinical Chemistry. Philadelphia: WB Saunders,
1994: 2161-2217.

6. Tietz N, ed. Clinical Guide To Laboratory Tests, WB Saunders, 1983: 258-259.

TECHNICAL SERVICE

For technical assistance with this product, in the U.S.,
please call our Technical Service Department at (800)
531-5535. Outside of the U.S., please call (830) 249­0772 or FAX +[phone].

AVAILABILITY

Reference No. Product Description
901025 STAT-Site

(4 x 25/Container), and CODE Key)

503000 STAT-Site

6 x 1.5 mL (3 Low and 3 High level)

900905 STAT-Site

5 Batteries (approximately 5,000 tests)
900900 STAT-Site
202012 12 µL Transfer Tubes (100 tubes/bag)

® MHgb

Test Cards (100 Test Cards,

®

Hemoglobin Controls

® MHgb

Battery Pack

® MHgb

Meter (Battery Included)

To order call [phone]

LP DISCLAIMS ALL EXPRESS AND IMPLIED

WARRANTIES OF THE MERCHANTABILITY AND FITNESS PERTAINING
TO THIS PRODUCT WHICH ARE NOT EXPRESSLY DETAILED IN THIS
PACKAGING INFORMATION OR A WRITTEN AGREEMENT BETWEEN
THE BUYER AND SELLER OF THIS PRODUCT.

LP MAINTAINS THAT THIS PRODUCT

CONFORMS TO THE INFORMATION CONTAINED IN THIS INSERT.
PURCHASER MUST DETERMINE THE SUITABILITY OF THE PRODUCT
FOR ITS PARTICULAR USE. USE ONLY IN ACCORDANCE WITH
LABELING INSTRUCTIONS.

Distributed by :

www.CLIAwaived.com

TEL: Toll Free 1-888-882-7739

E-mail: [e-mail]

Whole Blood
Hemoglobin
T est Cards

REF/Cat.# 901025

Use only with STAT-Site® M
For in vitro diagnostic use only.

CLIA Category - Waived

Hgb

Meter.

CODE KEY

CODE meter with

this key before

using this pack

of Test Cards.

INTENDED USE

Hgb

The STAT-Site® M

Test Kit is intended for the
quantitative determination of hemoglobin in whole blood using
the STAT-Site

® MHgb

Meter. The STAT-Site® M

Hgb

Test
may be used with adults, infants, and children in a physician’s
office or other professional point-of-care setting.

SUMMARY AND PRINCIPLE

Hemoglobin is the oxygen-carrying pigment and main component of red
blood cells. Low hemoglobin levels may indicate anemia, recent
hemorrhage or fluid retention. Elevated hemoglobin levels may indicate
hemoconcentration from polycythemia or dehydration.

The ST AT-Site® M

Hgb

Test provides a direct reading of hemoglobin
concentration in whole blood between 6 and 21 g/dL. Values below or
above this range will be reported as <Lo> or <Hi> respectively .

The STAT-Site® M

Hgb

Test consists of a plastic card with reagent pads*
for determining the concentration of hemoglobin. When a drop of
whole blood is applied to the top of the

STAT-Site® M

Hgb

Test Card,
hemolysis occurs, with release of hemoglobin. Sodium nitrite converts
the hemoglobin to methemoglobin. Sodium azide then reacts with
methemoglobin to form azide-methemoglobin, which is brown in color
and is detected at 565 nm with a small portable reflectance analyzer.
The amount of the color produced due to azide-methemoglobin is
proportional to the concentration of hemoglobin in the sample.

1

REAGENTS

Reagents used in STAT-Site® M
ingredients:

Sodium azide 0.6% w/w
Sodium nitrite 0.8% w/w
Inactive ingredients: 98.6% w/w

Hgb

Test Cards contain the following

PRECAUTIONS

• For in vitro diagnostic use.

• Do not use with serum or plasma.

• Fetal, newborn, or variant hemoglobin samples have not been

evaluated with ST AT-Site® M

Hgb

.

Children as young as 3 weeks

old were tested and included in the study.

• As with all chemical reagents, contact with the skin should be

avoided with the reactive areas of the Card.

• Handle blood specimens as potentially infectious samples and

follow the guidelines established by the Centers for Disease Control
(CDC) Atlanta, GA, for blood collection and handling (Document

20 CFR 1910.1030).

*

U.S. Patent 5,104,619

• If the patient is experiencing symptoms which are not consistent
with the hemoglobin results obtained AND you have eliminated
common procedural errors (described in the ST AT-Site® M

Hgb

Meter
User’s Guide) as the cause, follow your facility’s policies for
treating the symptoms and confirm the blood hemoglobin results
with another laboratory method.

• Never make significant changes to the patient’s medication program
or ignore physical symptoms without consulting a physician.

STORAGE AND STABILITY

The container of Test Cards can be stored at or below room tempera-
ture (28°C/82°F) until the expiration date. This product can be stored in
the refrigerator . If stored refrigerated, it is important to bring the
package to room temperature before opening and removing Test Cards
for testing.

The desiccant included with the Test Cards is not part of the test. It is
included only to keep the Test Cards dry. To ensure the remaining Test
Cards in the container are kept dry , keep the desiccant inside the
container and reseal immediately after removing the needed Test

Card.

Write the date opened on the container label where indi­cated. Once you open the container, Test Cards must be used
within 90 days.

Reseal the container immediately after removing a T est
Card. Test Cards should remain in the resealed con­tainer, with the dessicant, until being removed for use.

Avoid contact with the reagent pads on either side of the Test Card at
all times.
Each box of ST AT-Site® M
that must be inserted into the STAT-Site® M
be run. The CODE Key and Test Cards are matched for product type
and CODE number and are intended to be used with the Test Cards from
the same box . The CODE Key contains electronic information . Handle
with care and keep clean.

Dispose of the CODE Key after using the last Test Card from the
kit.

SPECIMEN COLLECTION AND PREPARATION

To perform a blood hemoglobin test with
on the STAT-Site® M
µL) of whole blood. Follow NCCLS Guideline H4A4 for obtaining a
capillary blood sample.

Capillary blood can be obtained from a skin puncture. The puncture site
should be cleaned and dried before pricking the site. Wipe away the
first drop with a gauze pad. Allow a large drop to form at the puncture
site. Avoid “milking” the finger to improve blood flow.

If using venous whole blood, collection tubes containing EDT A or
Heparin as anticoagulants are recommended. Do not use blood
collection tubes containing Sodium Fluoride or Oxalate/Fluoride.

Refrigerated blood should be allowed to reach room temperature
before testing.

Hgb

Test Cards comes with one CODE Key

Hgb

Meter you will need a drop (approximately 12

Hgb

Meter before the test can

STAT-Site® M

Hgb

Test Cards

pg1