HIV 1 RNA, QN PCR W/RFL GENO (RTI,PI,INTEGRASE)

1 Report Status: Final TESTCASE, TWENTYSIXP atient InformationSpecimen InformationClient InformationTESTCASE, TWENTYSIXDOB: 05/10/1984 AGE: 30 Gender:M Fasting: Patient ID:0418581 Specimen:BH045148 ARequisition:0418581 Collected:10/03/2014/ 08:00 EDTR eceived:10/03/2014/ 14:19 EDTR eported:10/07/2014/ 09:37 EDT(* A Copy Sent To)Client #: 205 AARRSSSCOLMENAR, ANTONIOQLS FAXAttn: KATHY400 EGYPT RDNORRISTOWN, PA 19403-3406 CLIENT SERVICES: 866-MyQuestSPECIMEN: BH045148 AQuest, Quest Diagnostics, the associated logo and all associated Quest Diagnostics marks are the trademarks of Quest :TEST CASE 26 HIV 1 RNA, QN PCR W/RFL GENO (RTI,PI,INTEGRASE)HIV 1 RNA, QN PCRLab: TXCTest NameResultReference Range/CommentsHIV 1 RNA, QN PCR 401 Hcopies/mLHIV 1 RNA, QN PCR HLog copies/mLREFERENCE RANGE: Copies/mL: <20 copies/mL Log copies/mL: < Log copies/mL This test was performed using the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 test kit version (Roche Molecular Systems, Inc.)

2 This test was performed using the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 test kit version (Roche Molecular Systems, Inc.)PAGE 1 OF 6 Report Status: Final TESTCASE, TWENTYSIXP atient InformationSpecimen InformationClient InformationTESTCASE, TWENTYSIXDOB: 05/10/1984 AGE: 30 Gender:M Fasting: YPatient ID:0418581 Specimen:BH045148 ACollected:10/03/2014/ 08:00 EDTR eceived:10/03/2014/ 14:19 EDTR eported:10/07/2014/ 09:37 EDT(* A Copy Sent To)Client #: 205 COLMENAR, ANTONIOCLIENT SERVICES: 866-MyQuestSPECIMEN: BH045148 AQuest, Quest Diagnostics, the associated logo and all associated Quest Diagnostics marks are the trademarks of Quest 1 GENOTYPE Lab.

3 TXC Test NameResultReference Range/Comments HIV 1 GENOTYPE DETECTED HIV Subtype: BAntiretroviral DrugsResistance PredictedMutations/ResultsNRTIsRT codons 1-335 ZDV (zidovudine or Retrovir )NOABC (abacavir or Ziagen )NOddI (didanosine or Videx )NO3TC (lamivudine or Epivir )YESM184I/MFTC (emtricitabine or Emtriva )YESM184I/Md4T (stavudine or Zerit )NOTDF (tenofovir or Viread )NONNRTIsETR (etravirine or Intelence )NOEFV (efavirenz or Sustiva )YESK103N,M230M/LNVP (nevirapine or Viramune )YESK103N,M230M/LRPV (rilpivirine or Edurant )NOPIsPR codons 1-99 FPV (fos-amprenavir or Lexiva )NOIDV (indinavir or Crixivan )

4 NONFV (nelfinavir or Viracept )NOSQV (saquinavir or Invirase )NOLPV (lopinavir or Kaletra )NOATV (atazanavir or Reyataz )NOTPV (tipranavir or Aptivus )NODRV (darunavir or Prezista )NO= Resistance Predicted= No Predicted Resistance= Probable or Emerging ResistanceOther Mutations Detected Gene NameMutationsRT K65K/N,Y188Y/C,F214L/FPR L10I,I13V,L33V/L,M36I,I62V,L63I,I64 VAll Trademarks are the properties of their respective determined by sequence analysis of the viral cDNA generated for this Quest Diagnostics June 2014 Interpretation AlgorithmPAGE 2 OF 6 Report Status: Final TESTCASE, TWENTYSIXP atient InformationSpecimen InformationClient InformationTESTCASE, TWENTYSIXDOB: 05/10/1984 AGE: 30 Gender:M Fasting: YPatient ID.

5 0418581 Specimen:BH045148 ACollected:10/03/2014/ 08:00 EDTR eceived:10/03/2014/ 14:19 EDTR eported:10/07/2014/ 09:37 EDT(* A Copy Sent To)Client #: 205 COLMENAR, ANTONIOCLIENT SERVICES: 866-MyQuestSPECIMEN: BH045148 AQuest, Quest Diagnostics, the associated logo and all associated Quest Diagnostics marks are the trademarks of Quest method used in this test is RT-PCR and sequencing of the HIV-1 polymerase gene. The phrases "resistance predicted" and "probableor emerging resistance" refer to the application of the interpretive rules. The FDA has not reviewed all of the interpretive rules used bythe laboratory to predict drug resistance.

6 FDA may not currently recognize some of the HIV gene mutations reported as predictive of drugresistance, but the laboratory considers these mutations to be associated with resistance to anti-viral drugs based on current clinical orscientific studies. The test has been validated pursuant to CLIA regulations and is not considered investigational or for research use decisions should be made in consideration of all relevant clinical and laboratory findings and the prescribing information for thedrugs. This test was developed and its performance characteristics have been determined by Focus Diagnostics.

7 Performance characteristicsrefer to the analytical performance of the 3 OF 6 Report Status: Final TESTCASE, TWENTYSIXP atient InformationSpecimen InformationClient InformationTESTCASE, TWENTYSIXDOB: 05/10/1984 AGE: 30 Gender:M Fasting: YPatient ID:0418581 Specimen:BH045148 ACollected:10/03/2014/ 08:00 EDTR eceived:10/03/2014/ 14:19 EDTR eported:10/07/2014/ 09:37 EDT(* A Copy Sent To)Client #: 205 COLMENAR, ANTONIOCLIENT SERVICES: 866-MyQuestSPECIMEN: BH045148 AQuest, Quest Diagnostics, the associated logo and all associated Quest Diagnostics marks are the trademarks of Quest 1 INTEGRASE GENOTYPE Lab.

8 TXCA ntiretroviral DrugsResistance PredictedINIsRAL (raltegravir or Isentress )PREDICTEDEVG (elvitegravir)PREDICTEDDTG (dolutegravir or Tivicay )PREDICTED= Resistance Predicted= No Predicted Resistance= Probable or Emerging Resistance Mutations DetectedE138EK,G140S,Q148 HAll Trademarks are the properties of their respective predictions for current specimen interpreted according to The Quest Diagnostics December 2013 Interpretation is an ingredient of the antiretroviral drug STRIBILD .The method used in this test is RT-PCR and sequencing of the HIV-1 integrase gene.

9 The phrases "resistance predicted" and "probableor emerging resistance" refer to the application of the interpretive rules. The FDA has not reviewed all of the interpretive rules used bythe laboratory to predict drug resistance. FDA may not currently recognize some of the HIV gene mutations reported as predictive ofdrug resistance, but the laboratory considers these mutations to be associated with resistance to anti-viral drugs based on current clinicalor scientific studies. The test has been validated pursuant to CLIA regulations and is not considered investigational or for research useonly.

10 Treatment decisions should be made in consideration of all relevant clinical and laboratory findings. This test was developed and itsperformance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance ofthe test. PERFORMING SITE:TXCFOCUS DIAGNOSTICS, 33608 ORTEGA HIGHWAY, SAN JUAN CAPISTRANO, CA 92690 Laboratory Director: JAY LIEBERMAN,MD, CLIA: 05D0644251 * Copy To Client: TEST CLIENT (HQ); QDRS - AUTODIAL LIST OF RESULTS PRINTED IN THE OUT OF RANGE COLUMN: HIV 1 GENOTYPE DETECTEDTXC HIV Subtype.