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Page 1 of 6hCG Control Set

FOR INFORMATIONAL USE ONLY



FOR INFORMATIONAL USE ONLY

Not to be used for performing assay. Refer to most current package insert accompanying your test kit.

hCG Control Set

(Positive and Negative)

Instructions for Professional Use

For In Vitro Diagnostic Use

Intended Use

The hCG Control Set is intended for use with the QuickVue®+ One-Step hCG Combo,

QuickVue® One-Step hCG Urine or Combo, and the RapidVue® hCG Test. These controls

provide an aid in the interpretation of positive and negative test results and verify

proper test performance.

sUmmary and explanatIon

The Positive Control contains puriﬁed human chorionic gonadotropin (hCG) in a buﬀered

solution. The Negative Control contains no detectable human chorionic gonadotropin.

The appearance of hCG shortly after conception and its continual increase during the

early stages of gestation make hCG an excellent indicator for the detection of early

pregnancy.

When used as qualitative controls in place of a patient sample in the QuickVue+ One-Step

hCG Combo, QuickVue One-Step hCG Urine or Combo, or RapidVue hCG Test, the results

may aid in the interpretation of positive and negative test results and verify test

performance.

prIncIple of the test

The hCG Control Set is designed to be used as qualitative control samples in accordance

with the QuickVue+ One-Step hCG Combo, QuickVue One-Step hCG Urine or Combo,

or RapidVue hCG Test package insert procedures.

Summary of content (6 pages)

PAGE 1
FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. hCG Control Set (Positive and Negative) Instructions for Professional Use For In Vitro Diagnostic Use Intended Use The hCG Control Set is intended for use with the QuickVue®+ One-Step hCG Combo, QuickVue® One-Step hCG Urine or Combo, and the RapidVue® hCG Test.
PAGE 2
FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. Reagents and Materials supplied  One (1) vial (4.5 mL) hCG Negative Control: Contains buffered solution, with 0.1% sodium azide as a preservative.  One (1) vial (4.5 mL) hCG Positive Control: Contains hCG in a buffered solution, with 0.1% sodium azide as a preservative. warnings and Precautions  For In Vitro Diagnostic Use.
PAGE 3
FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. test Procedure The hCG Control Set is to be used in accordance with the directions accompanying the QuickVue+ One-Step hCG Combo, QuickVue One-Step hCG Urine or Combo, or RapidVue hCG Test kits. When following these directions, the hCG Control Set is to be used in the same manner as a patient sample. 1.
PAGE 4
FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. QuickVue One-Step hCG Urine or Combo POSITIVE – The appearance of any pink-to-red line next to the letter “T” AND a blue line next to the letter “C” in the Results Window is a positive result. NEGATIVE – The appearance of a blue line next to the letter “C” AND NO pink-to-red test line is a negative result.
PAGE 5
FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. Physician’s Office Laboratory (POL) Study To evaluate the performance of the hCG Control Set in the physician’s office laboratory (POL), a panel consisting of 20 coded specimens were tested on three different days by physician’s office personnel at three different locations.
PAGE 6
FOR INFORMATIONAL USE ONLY  FOR INFORMATIONAL USE ONLY Not to be used for performing assay. Refer to most current package insert accompanying your test kit. Quidel Corporation Worldwide Headquarters 10165 Mckellar Court San Diego, CA 92121 USA www.quidel.