Description of Event or Problem · 1
IN 2009, A FAMILY PHYSICIAN CALLED QUESTIONING THE POSITIVE SERUM PREGNANCY TEST PERFORMED ON A PT DURING HOSPITALIZATION OF TWO DAYS PRIOR. THE MEDICAL TECHNOLOGIST RE-RAN THE SERUM PREGNANCY TEST AND IT WAS POSITIVE. SHE THEN FOUND A URINE SPECIMEN FROM THE PT AND RAN A URINE PREGNANCY TEST WHICH WAS NEGATIVE. A QUANTITATIVE HCG WAS ALSO PERFORMED ON THE BLOOD SPECIMEN WITH THE RESULT OF ZERO - GREATER THAN 15 WOULD BE CONSIDERED A POSITIVE. POSITIVE AND NEGATIVE CONTROLS WERE RUN WITH BOTH THE SERUM AND URINE PREGNANCY TESTS AND THE QUANTITATIVE HCG; THE RESULTS WERE AS EXPECTED - NEGATIVES WERE NEGATIVE AND POSITIVES WERE POSITIVE. THE MEDICAL TECHNOLOGIST CALLED THE DOCTOR BACK AND RELAYED THE FINDINGS OF HER INVESTIGATION AND INDICATED THAT THE RESULT WAS A FALSE POSITIVE. THE TEST RESULT IN THE MEDICAL RECORD WAS CORRECTED TO REFLECT A NEGATIVE RESULT. THE FOLLOWING INFO WAS IN RESPONSE TO QUESTIONS ASKED OF TECHNICAL CONSULTANTS AT OUR CONSULTING LAB: WE HAVE TO REMEMBER THAT THE KIT ASSAY IS A SCREENING TEST. THE PRESENCE OF HETEROPHILE ANTIBODIES OR NON-SPECIFIC PROTEIN BINDING MAY CAUSE FALSE-POSITIVE RESULTS OR FALSE NEGATIVE RESULTS IN SENSITIVE IMMUNOASSAYS. IF A QUALITATIVE INTERPRETATION IS INCONSISTENT WITH THE CLINICAL EVIDENCE, RESULTS SHOULD BE CONFIRMED BY AN ALTERNATIVE HCG METHOD. THE MEDICAL TECHNOLOGIST COMMENTED THAT SOMEONE FROM ANOTHER LAB IN STURGEON BAY, WI ALSO EXPERIENCED THE SAME PROBLEM WITH THE SAME TEST KIT AND HAD GOTTEN THE COMPANY TO REIMBURSE THE PT FOR THE ADDED EXPENSE OF THE FOLLOW-UP, PRODUCT: CLEARVIEW HCG COMBO II PRODUCT LOT# 8070176 EXP. DATE: 07/2010. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: RULE OUT PREGNANCY.