Waived HCG testing
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I'm curious as to what waived HCG kit people are using in physician offices. Our current kit is the Alere HCG combo. The quality controls states every new lot/shipment and every 30 days. I'm wondering if all HCG kits have a monthly QC process. I fear this will be hard to monitor.
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We use the Consult hCG Casette. It also has the same QC frequency requirements. To simplify how often to run QC I recommend the clinics to run external QC when they open a new kit and then once a month after that. If you have them QC everytime they open a new kit then that will cover all new lots and shipments.
We are using hCG Cassette Rapid Test(Urine only) by Cardinal Health. QC is once per month and new lot and or new shipment. if QC is done every new kit/box, that covers your QC requirements.
We use both Medline strip and cassette HCG. Not quite sure which one is best but they both are the same in directions and time frame. Just one you dip the other is in a cassette form. QC is once a month, new shipments or lots, and any new testing personnel.
We use Sekisui Osom hCG Combo, waived for Urine. External QC should be run with each new lot/shipment. No mention of monthly QC. Here is their package insert.
Hi Lacey,
We use the Siemens Clinitest kit that is run on the Clinitek analyzer. Package insert states to run external QC when opening each new reagent kit. No mention of monthly QC. We love this method because there is no timer involved, no subjective reading of the result, and no chance of someone reading the result well after the stated incubation time.
Susan L. Alford
Laboratory Point of Care Coordinator
Nanticoke Health Services
801 Middleford Road
Seaford, DE 19973
Phone: 302-629-6611 Ext. 2560
Fax: 302-628-6352
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Thank you everyone for your ideas.