EKF Diagnostics STAT-Site MHigh User manual

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

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 1. CODE the Meter

pg 2

Press to turn on power. To conserve battery

power, the meter will automatically shut off if left

idle for more than 2 minutes.

DISPLAY 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 Technical Service.

E-8 CODE Key Error Call 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 STAT-Site®MHgb. Children as young

as 3 weeks old were tested and included in the study.

•The performance characteristics of arterial blood have not

been determined.

Down

Button

Used to select options.

On/Off

Button

Used to turn the

meter off and on.

Test Card Holder

This is where the STAT-Site®MHgb

Test Cards are inserted.

Display

This is where the Test Results, Symbols and

Codes, and simple Messages that guide you

through the procedure are displayed.

Up Button

Used to access

memory, and select

options.

Test Card

Platform Tab

Helps you remove the Test

Card Platform.

Test Card

Platform

Can be removed to

provide access to

battery, CODE Key,

and to clean.

Figure 1

Materials Provided

• STAT-Site®MHgb Test Cards

• 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®MHgb Meter (Catalog #900900).

TEST PROCEDURE

The STAT-Site®MHgb Test procedure is detailed in this

insert and in the STAT-Site®MHgb Meter User’s Guide.

Before You Test: Read the STAT-Site®MHgb Meter

User’s Guide for complete information on meter setup,

maintenance and display messages.

QUALITY CONTROL

To assure consistent performance of your STAT-Site®MHgb

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 tech-

nique 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 TechnicalAssistance section

of the STAT-Site®MHgb User’s Guide before calling Technical

Service.

pg 3

EXPECTED RESULTS

Different blood hemoglobin values have been reported in the

literature (2,3,4,5).

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

infant to adult levels.

Due to the wide range of conditions (dietary, geographical,

smoking, exercise, recumbency, etc.) which affect reference

values (6), it is recommended that each laboratory establish its

own expected ranges.

Figure 2

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 deliver-

ing 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 finger-

stick). 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.

STEP 3. Apply the Sample

About Obtaining The Fingerstick Sample

•Washing 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.

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).

STEP 2. Insert the Test Card

EST

ESULT

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®MHgb 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. To 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.

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 SUp button to display the last result.

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

SING

EMORY

CODE THE METER.

Figure3 Figure 4

INSERT THE TEST CARD.

APPLY THE SAMPLE.

Figure 8

(Optional-

see Step 3)

Figure 7

Figure 6

Figure 5

Whole Blood

Hemoglobin

Test Cards

REF/Cat.# 901025

Use only with STAT-Site®MHgb Meter.

For in vitro diagnostic use only.

CLIA Category - Waived

CODE KEY

CODE meter with

this key before

using this pack

of Test Cards.

pg1

2. Within Run Precision - Precision studies with the STAT-

Site®MHgb method using whole blood samples yielded the

following mean values, standard deviations (SD), and coeffi-

cients 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

PERFORMANCE CHARACTERISTICS

3. Total Precision –

Total 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

www.CLIAwaived.com

TEL: Toll Free 1-888-882-7739

E-mail: [email protected]

4. Accuracy -

The STAT-Site M Hgb system was evaluated at three clinical sites

with a patient population consisting of adults, children, and

infants.

The correlation obtained between STAT-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 STAT-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 STAT-Site®MHgb Test.

•If the patient is experiencing symptoms which are not consistent

with the hemoglobin results obtainedAND you have eliminated

common procedural errors (described in the STAT-Site

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.

INTENDED USE

The STAT-Site®MHgb Test Kit is intended for the

quantitative determination of hemoglobin in whole blood using

the STAT-Site®MHgb Meter. The STAT-Site®MHgb 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 STAT-Site

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

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®MHgb

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.

REAGENTS

Reagents used in STAT-Site®MHgb Test Cards contain the following

ingredients:

Sodium azide 0.6% w/w

Sodium nitrite 0.8% w/w

Inactive ingredients: 98.6% w/w

PRECAUTIONS

•For in vitro diagnostic use.

•Do not use with serum or plasma.

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

evaluated with STAT-Site

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).

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 indi-

cated. Once you open the container, Test Cards must be used

within 90 days.

Reseal the container immediately after removing a Test

Card. Test Cards should remain in the resealed con-

tainer, 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 STAT-Site

Hgb

Test Cards comes with one CODE Key

that must be inserted into the STAT-Site

Hgb

Meter before the test can

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

STAT-Site®MHgb

Test Cards

on the STAT-Site

Hgb

Meter you will need a drop (approximately 12

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 EDTAor

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.

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.

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) 249-

0772 or FAX +(830) 249-0851.

TECHNICAL SERVICE

Reference No. Product Description

901025 STAT-Site®MHgb Test Cards (100 Test Cards,

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

503000 STAT-Site®Hemoglobin Controls

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

900905 STAT-Site®MHgb Battery Pack

5 Batteries (approximately 5,000 tests)

900900 STAT-Site®MHgb Meter (Battery Included)

202012 12 µL Transfer Tubes (100 tubes/bag)

To order call (858) 481-5031

AVAILABILITY

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.

U.S. Patent 5,104,619

pg 4

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

5 7 9 11131517192123

Expected conc (g/dL)

Observed conc (g/dL)

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