Orasure Technologies, Inc. · NASDAQ:OSUR
Orasure Technologies — Technical Presentation
58 slides from Orasure Technologies's technical presentation
Slide 1: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test
Slide 2: The Importance of Routine Rapid HIV Testing
The Importance of Routine Rapid HIV Testing
Slide 3: Approximately 1 in 5 HIV+ people do not know it, causing over 50% of new infections
While approximately 1 in 5 people who are HIV+ do not know it, they cause over 50% of new infections ~20% Unaware of ~50-70% of New Infection Infections ~80% Aware of ~30-50% of New Infection Infections People living with HIV/AIDS ~1.1 million New infections per year ~56,300 AMA Jour of Ethics, Dec
Slide 4: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test • Simple • Rapid HIV-1/2 antibody testing with oral fluid collection – results in 20 minutes • Accurate • Results with >99% sensitivity and specificity across all specimen types • Versatile • Testing platform suitable for both clinical and non-clinical s
Slide 5: Overview of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Overview of the® OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Slide 6: Intended Use
Intended Use ® • The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2) in oral fluid, venipuncture whole blood, fingerstick whole blood, and plasma specimens. • For in vitro diagnostic use
Slide 7: Clinical Laboratory Improvement Amendments (CLIA)
Clinical Laboratory Improvement Amendments (CLIA) CLIA Certificate of Waiver • The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) • The objective of the CL
Slide 8: OraQuick ADVANCE is a CLIA-Waived Test
OraQuick ADVANCE ® is a CLIA-Waived Test CLIA Certificate of Waiver • OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is CLIA-Waived for the following samples: • Oral fluid • Fingerstick whole blood • Venipuncture whole blood
Slide 9: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test • Single-use testing device with Reusable Developer Test built-in procedural control Solution Stand Vial Collection • Single-use test developer Loop solution vial Absorbent Packet Flat • Reusable test stand Pad Test Result Device • Disposable single-use
Slide 10: Clinical Features: Operating Principle
OraQuick ADVANCE ® Clinical Features Operating Principle Anti-Human Antibody Colloidal Gold Human Antibodies Conjugated HIV Antigen to Protein A HIV-1/2 Antibodies Control Test Conjugate pad with colloidal Line Line gold particle bound to protein A. Cellulose Flat Membrane Pad Using a lateral flow p
Slide 11: Clinical Features: Operating Principle
OraQuick ADVANCE ® Clinical Features Operating Principle Anti-Human Antibody Colloidal Gold Human Antibodies Conjugated HIV Antigen to Protein A HIV-1/2 Antibodies Control Test “T” “C” Line Line Absorbent Pad Colloidal gold particles containing HIV antibodies bind to the HIV antigen “T” line forming
Slide 12: Clinically Proven with >99% Accuracy
Clinically Proven with >99% Accuracy • What defines accuracy? Sensitivity: The ability to detect a true positive. Specificity: The ability to detect a true negative
Slide 13: Clinically Proven with >99% Accuracy
Clinically Proven with >99% Accuracy Claim Sensitivity Specificity Claim Sensitivity Specificity HIV-2* 100.0% - Oral Fluid 99.3% 99.8% Fingerstick 99.6% 100.0% Whole Blood Plasma 99.6% 99.9% *HIV-2 (Based on >800 banked serum/plasma specimens. In addition, FSWB and OF tests were done on 3 HIV-2 inf
Slide 14: Tips to Avoid False Positive and False Negative Results
Tips to Avoid False Positive and False Negative Results • In order to ensure accurate results are obtained, specimen collection is important. The following may cause inaccurate results: • Improper oral fluid specimen collection (over or under swabbing) • Not following proper fingerstick collection p
Slide 15: Test Kit - Available Packaging
Test Kit - Available Packaging Kit Size 100 Count 25 Count Item No. 1001-0078 1001-0079 Reusable Test Stand 10 5 Specimen Collection Loops 100 25 Subject Information Pamphlets 100 25 Package Insert 1 1 Customer Letter 1 1 Shelf Life 30 Months from Date of Manfacture Storage Requirements 2—27°C (36 —
Slide 16: Additional Materials Required and Available as an Accessory Kit
Additional Materials Required and Available as an Accessory Kit OraQuick ADVANCE® Kit Controls Positive Controls • Black-capped vial - inactivated human plasma positive for antibodies to HIV-1 • Red-capped vial - inactivated human plasma positive for antibodies to HIV-2 Negative Control • White-capp
Slide 17: Additional Materials Required
Additional Materials Required • Timer or Watch • Biohazard Waste Container • Disposable, Absorbent Workspace Cover Additional Required Phlebotomy Materials (WB, Plasma): • Disposable Gloves • Sterile Lancet • Phlebotomy materials • Centrifuge • Antiseptic Wipe • Sterile Gauze Pads
Slide 18: Test Preparation
Test Preparation Rvs —, ee. ee < — QraSure Technologies, Inc. =Or. a Qu IC. Kk me ADVANCE?
Slide 19: Prior to Testing
Prior to Testing • Remember to observe “Universal Precautions” at all times. • Read product instructions first. • Gather testing materials. • Let test come to operating temperature. • Set up workspace cover and reusable Test Stand on a flat level surface. • Put on disposable gloves if working with b
Slide 20: General Test Preparation
General Test Preparation • Check expiration date on OraQuick ADVANCE® Pouch. • Open two chambers of Divided Pouch by tearing at the notches. • Leave the Test Device in the Pouch. • Remove the Developer Vial. Gently rock the cap back and forth to remove. • Slide the Vial into the top of one of the sl
Slide 21: General Test Preparation
General Test Preparation • Remove test device from Pouch. DO NOT touch the flat pad. • Label device with subject information. DO NOT block holes on back of device. NOTE: Test Device must be inserted into vial within 30 minutes of sample introduction. • Make sure an Absorbent Packet is present. If no
Slide 22: Specimen Collection and Test Initiation
Specimen Collection and Test Initiation
Slide 23: Universal Precautions
Universal Precautions Handling of Potentially Infectious Human Samples • Before handling any specimens please refer to your facility’s procedures on universal precautions. • Universal guidelines stress that all patients should be assumed to be infectious for blood-borne diseases such as AIDS and hep
Slide 24: Prior to Oral Fluid Specimen Collection
Prior to Oral Fluid Specimen Collection • Ensure prior to testing that the subject has not had anything to eat, drink (including water) or has chewed gum for at least 15 minutes. • Have the subject wait for at least 30 minutes prior to testing if they have used any oral care products.
Slide 25: Oral Fluid – Specimen Collection
Oral Fluid – Specimen Collection • Place the flat pad above above the teeth against the outer gum. • Gently swab completely around the outer gums, both upper and lower, one time around, using the Flat Pad. • DO NOT swab the roof of the mouth, the inside of the cheek or the tongue. • NOTE: It is okay
Slide 26: If Device is transported prior to testing
If Device is transported prior to testing • NOTE: When collecting oral fluid specimens, the Test Device must be inserted into Developer Solution vial within 30 minutes of collection • Blood and plasma insertion within 60 minutes • A test device containing an oral fluid specimen that is not inserted
Slide 27: Oral Fluid – Test Procedure
Oral Fluid – Test Procedure • Insert Flat Pad of device into the bottom of Developer Vial. • Start timing test. • Pink fluid will travel up Result Window. Fluid disappears as test develops. DO NOT remove device while test is running. • Read results after 20 minutes but not more than 40 minutes. Adeq
Slide 28: Fingerstick – Specimen Collection
Fingerstick – Specimen Collection • Use an antiseptic wipe; clean finger of person being tested. Dry completely. • Use sterile lancet, puncture skin off center of finger pad. • WIPE first droplet with gauze. Hold the hand downward for new droplet. Gently apply pressure to express if needed. • With n
Slide 29: Fingerstick – Mixing Specimen
Fingerstick – Mixing Specimen • Insert blood-filled end of Loop into the vial. Be careful not to touch the sides of the vial. • Use Loop to stir sample in Vial. Dispose of used loop in biohazard waste container. • Check Solution to make sure it appears pink in color if using whole blood.
Slide 30: Fingerstick – Test Procedure
Fingerstick – Test Procedure • Insert Flat Pad of device into the bottom of Developer Vial. • Start timing test. • Pink fluid will travel up Result Window. Fluid disappears as test develops. DO NOT remove device while test is running. • Read results after 20 minutes but not more than 40 minutes. Ade
Slide 31: Whole Blood – Specimen Collection
Whole Blood – Specimen Collection • Use standard phlebotomy procedures, collect whole blood sample with one of the following collection tubes: • EDTA, Sodium Heparin, or Sodium Citrate. • Mix blood tube by inversion. • With new Specimen Collection Loop, dip loop into test tube. • Visually inspect th
Slide 32: Whole Blood – Mixing Specimen
Whole Blood – Mixing Specimen • Insert blood-filled end of Loop into the vial. Be careful not to touch the sides of the vial. • Use Loop to stir sample in Vial. Dispose of used loop in biohazard waste container. • Check Solution to make sure it appears pink in color if using whole blood.
Slide 33: Whole Blood – Test Procedure
Whole Blood – Test Procedure • Insert Flat Pad of device into the bottom of Developer Vial. • Start timing test. • Pink fluid will travel up Result Window. Fluid disappears as test develops. DO NOT remove device while test is running. • Read results after 20 minutes but not more than 40 minutes. Ade
Slide 34: Plasma – Specimen Collection
Plasma – Specimen Collection • Collect a whole blood sample in a blood collection tube containing an anticoagulant. • Centrifuge the blood to separate cells from plasma. • With new Specimen Collection Loop, dip loop into the plasma specimen. • Visually inspect the Loop to make sure that it is comple
Slide 35: Plasma – Mixing Specimen
Plasma – Mixing Specimen • Insert plasma-filled end of Loop into the vial. Be careful not to touch the sides of the vial. • Use Loop to stir sample in Vial. Dispose of used loop in biohazard waste container.
Slide 36: Plasma – Test Procedure
Plasma – Test Procedure • Insert Flat Pad of device into the bottom of Developer Vial. • Start timing test. • Pink fluid will travel up Result Window. Fluid disappears as test develops. DO NOT remove device while test is running. • Read results after 20 minutes but not more than 40 minutes. Adequate
Slide 37: Test Interpretation
Test Interpretation =OraQuick ADVAN laa HIV-1/72
Slide 38: Test Reading & Interpretation
Test Reading & Interpretation • Non-reactive result • Reactive result • Invalid
Slide 39: Reading a Non-Reactive Test
Reading a Non-Reactive Test A test is NON-REACTIVE if: • A reddish-purple line appears next to the triangle labeled “C” and no line appears next to the triangle labeled “T”.
Slide 40: Interpreting a Non-Reactive Test
Interpreting a Non-Reactive Test A Non-Reactive test result means that HIV-1 and HIV-2 antibodies were not detected in the specimen. The test result is interpreted as NEGATIVE for HIV-1 and HIV-2 antibodies. Follow CDC Guidelines to inform subject of test result and interpretation.
Slide 41: Reading a Reactive Test
Reading a Reactive Test A test is REACTIVE if: • A reddish-purple line appears next to the triangle labeled “C” and a reddish- purple line appears next to the triangle labeled “T”. Lines may vary in intensity. • NOTE: The test is reactive if a complete reddish-purple line appears next to the “T” tri
Slide 42: Interpreting a Reactive Test
Interpreting a Reactive Test A Reactive test result means that HIV-1 and/or HIV-2 antibodies have been detected in the specimen. The test result is interpreted as PRELIMINARY POSITIVE for HIV-1 and/or HIV-2 antibodies. Follow CDC Guidelines to inform subject of test result and interpretation.
Slide 43: Reading an Invalid Test
Reading an Invalid Test a b c d e f g A test is INVALID if: • No reddish-purple lines appears next to the triangle labeled “C” (see picture a and b), or • A red background in the Results Window makes it difficult to read the result after 20 minutes (picture c), or • If any of the lines are NOT insid
Slide 44: Interpreting an Invalid Test
Interpreting an Invalid Test a b c d e f g An Invalid test result means that there was a problem running the test, either related to the specimen or to the Device. IT CANNOT BE INTERPRETED. Repeat test with a new Pouch and a new oral fluid, fingerstick or venipuncture whole blood, or plasma sample.
Slide 45: General Test Clean Up
General Test Clean Up • Dispose of the used test materials in a biohazard waste container. • When using gloves, change your gloves between each test to prevent contamination. Throw away the used gloves in a biohazard waste container. • Use a freshly prepared 10% solution of bleach to clean up any sp
Slide 46: Quality Assurance
Quality Assurance Rvs —, ee. ee < — QraSure Technologies, Inc. =Or. a Qu IC. Kk ADVAN CE®
Slide 47: Quality Control
Quality Control • Positive and Negative Kit Controls provide: • Quality Control to: • Assure test performance • Provide for user proficiency • Positive Controls • Are calibrated specifically to a very low assay reactivity level (challenge line). • Low assay performance reaffirms assay functionality
Slide 48: Test Kit - Kit Controls
Test Kit - Kit Controls Positive Controls • Black-capped vial - inactivated human plasma positive for antibodies to HIV-1 • Red-capped vial - inactivated human plasma positive for antibodies to HIV-2 Negative Control • White-capped vial - human plasma negative for antibodies to HIV-1 and HIV-2 • Suf
Slide 49: Test Kit Control Contents
Test Kit Control Contents #1001-0077 Test Kit Control Positive HIV-1 Control Vial (1) (Black Cap) 0.2 mL Positive HIV-2 Control Vial (1) (Red Cap) 0.2 mL Negative Control Vial (1) (White Cap) 0.2 mL Package Insert 1 Storage Requirements 2—8°C (35—46°F)* Shelf-Life 1 Year from manufacture date or 8 w
Slide 50: Performing Kit Controls
Performing Kit Controls Run one positive HIV-1 control (+), one positive HIV-2 control (+), and one negative control (-) for: • Each new operator, • Each new lot of test kits, • Each new shipment of test kits, • Test kit storage temperature falls outside 2-27°C; 35-80°F, • Testing area temperature f
Slide 51: Performing Kit Controls
Performing Kit Controls • Getting Started • Read the OraQuick ADVANCE® Kit Control Package Insert. • Remember to observe “Universal Precautions” at all times. • Follow directions for inspecting and opening pouches. • Follow directions for setting up workspace. • Label devices for Negative, Positive-
Slide 52: Performing Kit Controls
Performing Kit Controls • Open a Kit Control vial. • Insert round end of a new Specimen Collection Loop into the reagent vial. • Remember to use separate unused Loop for each control NOTE: The Kit Control reagents reagent. are clear to straw-colored. Do not use if the reagent appears cloudy or disco
Slide 53: Performing Kit Controls
Performing Kit Controls • Immerse Loop into Developer Solution Vial. • DO NOT touch side of vial. • Use the loop to stir contents. • Discard Loop in a Biohazard Waste Container.
Slide 54: Performing Kit Controls
Performing Kit Controls • Retrieve correct labeled device. • Insert Flat Pad of device into the bottom of Developer Vial. • Start timing test. • Pink fluid will travel up Result Window. Fluid disappears as test develops. DO NOT remove device while test is running. • Read results after 20 minutes but
Slide 55: Performing Kit Controls
Performing Kit Controls Example of a Example of a Expected Results: Non-Reactive Reactive Result Result (Preliminary • Negative Control will produce a (Negative) Positive) Non-Reactive test result. A line should be present at “C” triangle in result window. • Positive Controls will produce a Reactive
Slide 56: Kit Control Failure
Kit Control Failure • If test result does not perform as expected • Repeat test using new Test Device, Developer Solution Vial, and Control Specimen. • If test result does not perform a second time • Discontinue testing and contact OraSure Technologies.
Slide 57: OraQuick ADVANCE Interpretation Review
OraQuick ADVANCE ® Interpretation Review A B C D E F G 1-800-ORASURE • 1-800-672-7873
Slide 58: OraQuick ADVANCE Interpretation Review
OraQuick ADVANCE ® Interpretation Review Reactive Invalid Non‐Reactive Invalid Invalid Invalid Reactive A B C D E F G 1-800-ORASURE • 1-800-672-7873