Product Manual

ManualsBrandsSiemens Diagnostics ManualsLab & PhlebotomyMultistix 5 Reagent Strips - 100/btl

SUMMARY AND EXPLANATION / INTENDED USE: Bayer Reagent

Strips for Urinalysis include test pads for protein, blood, leukocytes,

nitrite, glucose, ketone (acetoacetic acid), pH, specific gravity, bilirubin

and urobilinogen.

Please refer to the carton or bottle label to see which

tests are included on the product you are using.

Bayer Reagent Strips are for professional use in near-patient (point-of-

care) and centralized laboratory locations. The strips are intended for use

in at-risk patient groups to assist diagnosis in the following areas:

1–3

• kidney function

• urinary tract infections

• carbohydrate metabolism (e.g., diabetes mellitus)

• liver function

The strips also measure physical characteristics, including acid-base bal-

ance and urine concentration. Test results can be used along with other

diagnostic information to rule out certain disease states and to determine

if microscopic analysis is needed.

1,4

Bayer Reagent Strips are ready to use upon removal from the bottle

and the entire reagent strip is disposable. The strips may be read visually,

requiring no additional laboratory equipment for testing. The strips can

also be read instrumentally, using the CLINITEK

family of Urine

Chemistry Analyzers and the appropriate software; contact your product

representative for further information.

Bayer Reagent Strips are for

in vitro

diagnostic use. They have been

determined to be nonhazardous under the guidelines issued by OSHA in

29 CFR 1910.1200(d).

INFORMATION REGARDING CLIA WAIVER:

• The CLINITEK STATUS and CLINITEK 50 Analyzers are CLIA waived

only when used with Bayer Reagent Strips, manufactured by Bayer

HealthCare LLC.

• These tests are CLIA waived when read visually and when run on the

CLINITEK STATUS and CLINITEK 50 Analyzers. A certiﬁcate of CLIA

waiver is required to perform these tests in a waived setting. To obtain a

Certiﬁcate of Waiver, contact your state department of health or visit the

CMS web site for an application, Form CMS-116.

• Failure to adhere to the instructions for use, including instructions for

limitations, intended use, and performing quality control testing, is off-

label use, resulting in these tests being categorized as high complex-

ity and subject to all CLIA regulations.

SPECIMEN COLLECTION AND PREPARATION: Collect freshly-voided

urine in a clean container and test it as soon as possible. The container

should allow for complete dipping of all reagent strip areas. A ﬁrst-morn-

ing specimen is preferred but random collections are acceptable. Test

the urine within two hours after voiding, sooner if testing for bilirubin or

urobilinogen. If unable to test within the recommended time, refrigerate

the specimen immediately and let it return to room temperature before

testing. Work areas and specimen containers should always be free of

detergents and other contaminating substances.

Procedure

1. • Collect a fresh urine specimen in a clean, dry container.

• Mix well just before testing.

• Remove one strip from the bottle.

• Replace the cap.

2. • Dip all the test pads of the strip into

the urine.

• Immediately remove the strip.

• If reading the strip visually, start

timing.

3. Drag the

edge

of the strip against the

container rim to remove excess urine.

4.a. If reading visually:

• Compare each test pad to the corresponding row of color blocks

on the bottle label.

• Read each pad

at the time shown on the label,

starting with the

shortest time.

• Hold the strip close to the color blocks and match carefully.

• Read the pads in good light.

b. If using a CLINITEK instrument, carefully follow the directions given

in the appropriate instrument operating manual. The instrument will

automatically read each test pad at a speciﬁed time.

5. Report the results to the lab supervisor or physician.

RESULTS: With visual use, results are obtained in clinically meaningful

units directly from the Color Chart comparison. With CLINITEK instru-

ments, the test pads are “read” by the instrument and the results are dis-

played or printed as soon as they are available.

QUALITY CONTROL: Test known negative and positive specimens or

controls whenever a new bottle is ﬁrst opened. Water should NOT be used

as a negative control. Each laboratory should establish its own goals

for adequate standards of performance. CHEK-STIX

Positive and Negative

Control Strips provide a convenient basis for a quality control program.

test pad

color block

Multistix

10 SG • Multistix

9 • Multistix

9 SG • Multistix

8 SG •

Multistix

7 • N-Multistix

SG • N-Multistix

• Multistix

SG • Multistix

•

Bili-Labstix

Reagent Strips

Tests for Protein, Blood, Leukocytes, Nitrite, Glucose, Ketone (Acetoacetic Acid), pH, Speciﬁc

Gravity, Bilirubin and Urobilinogen in Urine.

Note: Package insert for use with the products listed below.

Summary of content (4 pages)

PAGE 1
Note: Package insert for use with the products listed below. Multistix® 10 SG • Multistix® 9 • Multistix® 9 SG • Multistix® 8 SG • Multistix® 7 • N-Multistix® SG • N-Multistix® • Multistix® SG • Multistix® • Bili-Labstix® Reagent Strips Tests for Protein, Blood, Leukocytes, Nitrite, Glucose, Ketone (Acetoacetic Acid), pH, Specific Gravity, Bilirubin and Urobilinogen in Urine.
PAGE 2
STORAGE: All unused strips must remain in the original bottle. Transfer to any other container may cause reagent strips to deteriorate and become unreactive. Store at temperatures between 15°–30°C (59°–86°F). Do not use the strips after their expiration date. Do not store the bottle in direct sunlight and do not remove the desiccant from the bottle. IMPORTANT NOTE: PROTECTION AGAINST EXPOSURE TO LIGHT, HEAT AND AMBIENT MOISTURE IS MANDATORY TO GUARD AGAINST ALTERED REAGENT REACTIVITY.
PAGE 3
pH: Expected values: The normal pH of urine can range from 4.6 to 8.0. Certain dietary conditions can produce acid or alkaline urines, which can be useful in the treatment of some calculi.1 Performance characteristics: The pH test area measures pH values from 5–8.5 visually and 5–9 instrumentally, generally to within one unit of the expected result. pH readings are not affected by variations in the urinary buffer concentration.
PAGE 4
AVAILABILITY: Bayer Reagent Strips for Urinalysis are available in bottles of 100 strips: MULTISTIX® 10 SG (#2161); MULTISTIX® 9 (#2162); MULTISTIX® 9 SG (#2163); MULTISTIX® 8 SG (#2164); MULTISTIX® 7 (#2165); N-MULTISTIX® SG (#2176); MULTISTIX® SG (#2177); N-MULTISTIX® (#2178); MULTISTIX® (#2179); and BILI-LABSTIX® (#2180). U.S. PATENT NUMBERS: Refer to the carton of the product you are using for applicable patent numbers.