Unassayed Heparin / PF4 Antibody Panel Frequently Asked Questions

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1 Please Consult the Product Package Insert Prior to Use Intended Use Q. What is the Intended Use of the Unassayed Heparin/PF4 Antibody Panel? A. The Unassayed Heparin/PF4 Antibody Control Panels are intended for use as unassayed quality control material to evaluate the precision and accuracy of qualitative laboratory test procedures that detect antibodies against the Heparin/Platelet Factor 4 ( HPF4 ) complex. They are intended for use with qualitative Heparin/Platelet Factor 4 antibody detection systems that permit the use of serum-based materials for routine quality control. Q. What is the difference between the Unassayed (PN & ) and Assayed (PN & ) Heparin/PF4 Antibody Panels? A. The unassayed Heparin/PF4 Antibody Control Panels supply antibody information (positive/negative) but do not have manufacturer-assigned analyte values. These controls have been developed specifically for use with the PIFA PlussPF4 Rapid Assay and other qualitative Heparin/Platelet Factor 4 antibody detection systems that permit the use of serumbased materials for routine quality control. The Heparin/PF4 Assayed Antibody Control Panels have been developed specifically for use with the PIFA Heparin/PF4 Rapid Assay. In addition to antibody classification, this panel also supplies HPF4 antibody analyte values for the control materials. Storage and Reagent Handling Q. How should the Unassayed Heparin/PF4 Antibody Panel be stored? A. As noted in the Package Insert, panel members should be stored at -70 C or colder. These conditions are required to maintain antibody stability and achieve the labeled expiration dating. If you wish to run controls more frequently, proceed to produce control sample aliquots. Single use aliquots which will be stored in appropriately sized cryovials at -70 C or colder, can be run as additional Quality Control samples. Please note that it is important to follow aseptic technique during the aliquot procedure. If panel members and/or aliquots are stored above -70 C, the samples may not perform per classification and can only be used for informational purposes not quality control. The labeled expiration dating would also be invalidated. Compiled by AKERS BIO, 201 Grove Road, Thorofare, New Jersey USA Page 1 of 6

2 Q. I don t have a -70 C freezer, do you have any suggestions for meeting my Quality Control needs for the PIFA PlussPF4 Rapid Assay? A. First, if possible, borrow space from another department who may have a -70 C or colder freezer. The control material is very small and doesn t take up much space. Controls should be analyzed as required by your laboratory s standard quality control policy. As the manufacturer, Akers Biosciences recommends that the Laboratory run controls upon receipt of a new lot of PIFA PlussPF4 Rapid Assay devices and after running 100 devices within the same lot. As unit-use devices, Quality Control samples can be run less frequently. Some customers have found the following approach helpful. Since your distributor may not provide lot-specific information when you place your order for PIFA PLUSS devices, when it is time to reorder, also order a new control panel. Run controls upon receipt of your shipment, even if there are no patient samples in queue. This should keep you in compliance until the next shipment (depending on the QC policy of your laboratory). Q. Do I have to use a quick thaw procedure? A. Yes, proteins will precipitate out of frozen specimens if they are thawed at room temperature. The quick thaw procedure should minimize protein shedding. Our control panel is frozen and comes on dry ice but it is processed under strict specifications in order to avoid the formation of particulates. Particulates could potentially interfere with the PIFA PlussPF4 device performance. Q. If I don t have a water bath capable of maintaining C, can I use a heating block? A. It is generally not recommended to use a heat block. AKERS BIO has found there is a great deal of temperature variation when using a heat block. It is possible to overheat the sample and thus cause damage to the HPF4 antibodies. If no other method is available, AKERS BIO recommends you monitor the heat block while thawing the control samples. Place a small amount of liquid in a tube in the heat block. Place a calibrated thermometer into the tube and monitor to insure the block remains within C for the 6 to 7 minute thaw period. Q. What happens if I forget about the control and it is heated for an extended period of time? A. More than likely, the positive sample will not perform per classification. The sample in each cryovial can quickly be overheated. The proteins contained in the HPF4 positive sample will degrade if exposed to excessive heat and they will not activate the reagent in the PIFA PLUSS device. The negative control will still work per classification but it is not a true indicator of device performance due to protein degradation. Compiled by AKERS BIO, 201 Grove Road, Thorofare, New Jersey USA Page 2 of 6

3 Q. The cryovial contains such a small volume, how can I accurately mix it? A. Inversion is not the mixing method of choice! We suggest the vial be vortexed to ensure mixing before use. It is important to have a homogenous dispersal of antibody throughout the sample. Insure sample is well mixed before use and before additional handling such as preparation of aliquots. Q. After I thaw the sample, how soon should I use it? A. It is best to use the sample immediately after thaw to maximize antibody reactivity. It is possible to keep the thawed sample at 2 to 8 C for a maximum of eight (8) hours prior to use. Remember: controls that have been kept refrigerated should warm to room temperature prior to use. This should take approximately thirty (30) minutes. Always mix well prior to use. Q. After use, how do I handle the remaining sample? A. When using HPF4 serum panel members from AKERS BIO, it is imperative to avoid multiple freeze-thaw cycles. Once thawed, the well mixed remainder of the control should be flash frozen, stored at 70 C and should only be subjected to one additional freeze-thaw cycle. You should get one initial run and at least one (1) additional sample from each control vial. Pipetting technique will affect the yield obtained from each vial. The Unassayed Heparin/PF4 Antibody Controls are intended for use with qualitative heparin/platelet factor 4 antibody detection systems that permit the use of serum-based materials for routine quality controls. Controls may be aliquoted into smaller volume samples after the initial thaw cycle. When you are done using the initial sample, separate the remaining volume into single use aliquots and return these back into frozen conditions ( 70 C ). We recommend using the smallest possible cryovials for storage. If a small volume aliquot is stored in a large volume tube, it is difficult to recover volume as the sample often coats the sides of the tube. It is also more prone to freezer burn due to the increased surface area. Q. What is meant by Follow asceptic techniques during the aliquot procedure? A. To protect the sample aliquot from bacterial contamination follow standard asceptic techniques. This would include use of sterile pipet tips and cryovials. A bacterially contaminated sample may non-specifically block the membrane filtration system leading to false positives. Q. I don t have time to aliquot; can t I just freeze/thaw the same sample? Compiled by AKERS BIO, 201 Grove Road, Thorofare, New Jersey USA Page 3 of 6

4 A. No! Repeated freeze/thaw cycles may diminish antibody activity. The Heparin/PF4 Antibody Panel members should only be exposed to two (2) freeze/thaw cycles; the initial thaw and one additional freeze/thaw cycle. Results Interpretation Q. How can I get an individual panel member s Certificate of Quality (C of Q) data? A. Unassayed Heparin/PF4 Antibody Panel members are identified as Heparin/PF4 Antibody POSITIVE or Heparin/PF4 Antibody NEGATIVE indicating the presence or absence of the antibody in the control sample. The classification is provided on each control vial. If you would like a CoQ for a specific control kit lot, this data can be accessed by looking up the control kit Lot Number (found on the outside of the box) on the Akers Biosciences website on the appropriate product webpage. This data can also be accessed by contacting technical service at (US: TEST). Q. Can I use a control from another Heparin/PF4 test kit with the PIFA PlussPF4 Rapid Assay devices? A. No, the unassayed Heparin/PF4 antibody controls are manufactured under strict guidelines to give our customers the highest quality controls for use as validation and QC samples. When using controls from other test kits, AKERS BIO cannot guarantee their sample matrix would be compatible with this assay. Controls from other test kits should not be used. Q. How can I get proficiency testing samples for the PIFA PlussPF4 Rapid Assay? A. Proficiency test samples for PIFA PlussPF4 Rapid Assay should be available starting in the summer of 2016 from the College of American Pathologists (CAP). Q. What can I do if I need to perform proficiency testing before that time or our proficiency samples don t come from CAP? A. If this happens, consult your survey and the governing body to clarify their requirements. It may be possible to blind and run unassayed Heparin/PF4 antibody panel members or an appropriately gathered characterized patient sample. Q. If the unassayed Heparin/PF4 antibody panel members are frozen, why can't I use my frozen specimens? A. If not handled meticulously, freezing and thawing will decrease antibody activity, and could cause a positive sample to produce a negative test result. Freezing/thawing may also cause Compiled by AKERS BIO, 201 Grove Road, Thorofare, New Jersey USA Page 4 of 6

5 certain proteins to precipitate out of solution, and cause other microparticulates or debris to form. These particulates can clog the pores in the membrane filter system in the test device, and could cause a negative sample to produce a positive test result. AKERS BIO manufactures our control panel members under very strict conditions to avoid the formation of any particulates and interfering substances. Q. I m using a small volume of control (150µL), does the temperature really matter? A. Yes! The overall temperature of both the control and the devices is very important. They should both warm to room temperature for a minimum of 30 minutes prior to use. The colder the reagent/sample mixture, the more slowly the antibody/antigen reaction occurs. Q. I m just a little short in the volume of control I have, can I run it anyway? A. No, an incorrect amount of sample can affect the test result! Individual Quality Control Plan Q. Are the Unassayed HPF4 Antibody Control Panels used with a CLIA waived assay? A. No, the Unassayed Antibody Control Panels are used with the PIFA PlussPF4 Rapid Assay which is classified as moderately complex by CLIA. Q. On December 31, 2015 the ability to use Equivalent Quality Control (EQC) policies expired. Laboratories are required to either follow the quality control regulations as outlined in CLIA 88 or develop an Individualized Quality Control Plan (IQCP) to replace the current EQC option. Does AKERS BIO supply manufacturer s recommendations to help meet the new quality control requirements under CLIA? A. Yes, Akers Biosciences Inc. has developed an IQCP Support Document, a useful template that can be customized for your laboratory s particular needs. It was developed using the Center for Medicare & Medicaid Services (CMS) and CDC publication Developing an IQCP, A Step By Step Guide. It is accompanied by a Training Quiz that can be used as part of your laboratory s ongoing training. Q. Does the template cover all aspects of the new CLIA requirements? A. No, although Akers Biosciences has provided a useful template for your use with our products, the CMS expects your IQCP to reflect your lab conditions and not what Akers Biosciences assumes about your laboratory operation and conditions. Compiled by AKERS BIO, 201 Grove Road, Thorofare, New Jersey USA Page 5 of 6

6 Q. Does my lab have to develop an IQCP for use with this product? A. No, your laboratory director is responsible for deciding whether the laboratory will utilize IQCP and for ensuring that the quality control plan (QCP) developed effectively meets the IQCP requirements. Alternately, your lab can follow the Quality Control Regulations outlined in CLIA 88 to replace Equivalent Quality Control policies. Q. How can I get the IQCP Support Document & Training Quiz? A. Both the IQCP Support Document and the Training Quiz can be found and downloaded from the Akers Biosciences website: or by calling TEST and requesting them. Compiled by AKERS BIO, 201 Grove Road, Thorofare, New Jersey USA Page 6 of 6