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Biochemical Diagnostics Has Been A Leading Provider of Forensic and Clinical Toxicology Products Since 1981

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 BIOCHEMICAL DIAGNOSTICS
PREGNANCY-SKREEN™

 

       hCG

 

      LIQUID

 

      CONTROL

 

      URINE

 

                                     Available in the following levels:

      Positive, 5 mL Vial

      Negative, 5 mL Vial

 

Pregnancy-Skreenä controls are prepared from human based urine available as a negative and at positive hCG levels
to qualitatively monitor the performance of urine pregnancy immunochromatographic detection devices and procedures.

 

 

      Please read the entire package insert before using the control urines

 

 

        Temperature Limit       Consult Instructions for Use       For In Vitro Diagnostic Use

 

  

Please call for additional information on our stock controls or our custom toxicology control manufacturing.
Custom manufacturing is available with many bottling options and constituent levels.

 

 

Rev. Nov 2006

                                                                                                                                                                    


  

INTENDED USE

 

The Biochemical Diagnostics, Inc. Pregnancy-SkreenÔ controls are intended to validate the performance of qualitative urinary hCG methods. They should be treated as any "unknown” specimen while following the specific protocol of the assay being used.

 

This product is intended to be used by health care professionals as an integral part of good laboratory practices.

 

SUMMARY AND EXPLANATION

 

The Pregnancy-Skreen product line of controls is manufactured using a human based urine matrix that has been stabilized

to insure that the product will be viable until the date of expiration. The positive control is spiked with hCG in a target range from 200-400 mIU/mL of urine matrix. The negative control is prepared from a urine pool that tested negative for hCG. The standard material used for spiking was obtained from human pregnancy urine lyophilized and found negative by ELISA  to HIV-1, antibody for HCV and for HBSAG. The initial assay of the lyophilized material used for spiking was performed by radioimmunoassay.  Subsequent testing of the control material is performed  qualitatively to ascertain that positive controls tested positive and the negative controls tested negative for the claimed life of the product.

 

DESCRIPTION

 

Each bottle contains stabilized human based urine in a convenient liquid form. Positive control urines have been spiked with known quantities of purified Human Chorionic Gonadotropin (hCG). Negative control urine is certified negative for the constituents listed in this insert.

CATALOG #    

DESCRIPTION

20100007

PREGNANCY-SKREEN™ hCG Liquid Control Urine,

                  Negative, 5 mL vial

 

20100005

PREGNANCY-SKREEN™ hCG Liquid Control Urine,                                     Positive, 5 mL vial    

 

           

 

                 

 

 

 PRECAUTIONS

 

For in vitro diagnostic use only

Please read the entire package insert before using the Pregnancy-Skreenä control urines. Please use the same safety precautions you would use for processing any "unknown” urine sample containing potentially infectious biological material. Protect product from exposure to direct sunlight. Discard control if cloudiness develops.

Do not use beyond the expiration date.

 

 

PRECAUTIONS, cont’d

 

Repeated dipstick immersion can compromise the performance of this product due to adsorption losses.  It is recommended that a maximum of 10 immersions be performed on an opened bottle of Pregnancy-Skreen control.

 

Contains sodium azide: To prevent formation of explosive metal azides dispose of discarded material by flushing or diluting with copious amounts of water or according to local governing regulations.

 

STORAGE & STABILITY

 

Unopened:

The controls are stable until the expiration date when stored refrigerated at

(2-8oC). When stored at room temperature (18-25oC) the controls are stable for 31 days or until the expiration date, whichever comes first.

This product should never be stored frozen.

 

After Opening:

The controls are stable for 31 days or until the expiration date, whichever comes first, when stored refrigerated (2-80C) or at room temperature (18-25oC).

 

 

PROCEDURE

 

  • Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE.

  • Pipette an appropriate aliquot of Pregnancy-Skreen™  control urine as required by the hCG immunochromatographic device or screening method.

 

 LIMITATIONS OF PROCEDURE

 

This control is meant to be used to validate the performance of qualitative urine hCG methods that screen urine for hCG levels consistent with pregnancy.

 

Consult test manufacturers instructions when using this product; changes in reagents, sample requirement, or methodology may effect test results.

This product is not meant to be used as a standard or calibrator.

 

Expected Results

 

The positive Pregnancy-Skreen™ control must test positive and the negative Pregnancy-Skreen™ control must test negative.