Other Diagnostic Tests

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Colleen Young
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1 Other Diagnostic Tests APTIMA HIV-1 RNA Qualitative Assay (approved in Oct 2006) Confirmation test (like Western Blot) Detects RNA of the HIV-1 virus (Nucleic Acid Amplification Test/ NAAT) First test approved for the detection of HIV-1 RNA to help diagnose HIV-1 infection Presence of HIV-1 RNA without antibodies present is indicative of acute or primary HIV-1 infection Process is not automated thus costly

2 Other Diagnostic Tests Oral (Transmucosal exudates) Orasure (EIA and WB Confirmatory) swab gum tissue; results in 3 days Urine Calypte (EIA) need confirmatory blood test if positive Vaginal secretions Wellcozyme HIV 1&2; use with rape victims

3 OraQuick Advance HIV-1/2 CLIA-waived for finger stick, whole blood, oral fluid; moderate complexity with plasma Store at room temperature Screens for HIV-1 and 2 Results in 20 minutes

4 Obtain finger stick specimen

5 Insert loop into vial and stir

6 Collect oral fluid specimens by swabbing gums with test device. Gloves optional; waste not biohazardous

7 Insert device; test develops in 20 minutes

8 Positive HIV-1/2 Reactive Control Positive Negative Read results betweem minutes

9 Uni-Gold Recombigen CLIA-waived for finger stick, whole blood; moderate complexity with serum, plasma Store at room temperature Screens for HIV-1 Results in 10 minutes

10 Add 1 drop specimen to well

11 Add 4 drops of wash solution

12 Positive Negative Read results in minutes

13 Home Based Testing Oraquick In-Home HIV Test FDA approved July 3, 2012 First OTC home use rapid test HIV 1 and HIV 2 Specimen: oral fluid 92% sensitivity/ 99.98% specificity Consumer support center available 24/7 Became available - October 2012 Cost approx. $40.00

14 Home Based Testing Specimen: Dried blood spot Accuracy: comparable to standard serology Toll free telephone support for test and result questions Anonymous Express HIV 1 test also available

15 WHAT DOES THAT MEAN? Determining one s HIV status is the first step in treatment decisions. Before 1985 we did not have screening tests for HIV because there was no treatment so why test. Blood was identified as a source of transmission and standard blood testing was done for all donated blood. Soon it was noted that individuals who desired to know their HIV status started donating blood. Hence the development of what we use today to test for HIV.

Maintain Safety of Donated Blood/Organs Screening done since 1985 for HIV Hepatitis B and C screening p24 antigen screening added in 1996 to increase early detection, increase

16 Maintain Safety of Donated Blood/Organs Screening done since 1985 for HIV Hepatitis B and C screening p24 antigen screening added in 1996 to increase early detection, increase safety; 2001 replaced by Nucleic Acid Based Test (more accurate) Infected individuals CANNOT DONATE, but can receive donations Different testing standards in other developing countries

17 CD4 cell count (cells/mm 3 ) HIV RNA (c/ml) HIV Disease Course Without Treatment Primary Infection 1200 Acute Retroviral Syndrome Wide spread dissemination of virus Constitutional symptoms Asymptomatic Period Constitutional Symptoms Opportunistic Infections Death Weeks 12 Years 8-10 Luber AD. Applied Therapeutics, Chapter 69; 2005.

18 HIV Seroconverting Illness Undiagnosed HIV 56,300 new HIV infections annually, 40-90% are symptomatic. Fever, fatigue, headache, myalgias, arthralgias. Lymphadenopathy, maculopapular rash (50%), oral/genital ulcers, aseptic meningitis (25%). Symptom duration is days to months, usually 2 weeks. Lymphopenia, thrombocytopenia, but atypical lymphocytes are uncommon.

19 CD4 Cell Count and Risk for Opportunistic Infections > 500 Between 350 and 500 < 350 Normal: Low risk of opportunistic infections Below normal: Increased risk of opportunistic infections Low: High risk of opportunistic infections On average, without treatment, a patient s CD4 cell count will decrease by 50 to 100 cells/year

Monitoring HIV Infection - CD4 T cells Conductor of Immune System Orchestra Normal Range: 600-1200 Causes of normal variability: stress,

20 Monitoring HIV Infection - CD4 T cells Conductor of Immune System Orchestra Normal Range: Causes of normal variability: stress, infection, time of day Indirect measure of damage to immune system. Lower CD4= more damage Measure at baseline, then every 3 to 6 months

21 Does an Undetectable Viral Load Mean HIV is Gone? NO! It means virus is below limits of test: <20 particles per ml for PCR test Medications are controlling HIV HIV CAN STILL BE TRANSMITTED! Viral Load will increase if meds are stopped Undetectable does not mean safer sex practices can be forgotten. Undetectable does not mean the patient is uninfected or cured.

22 OIs Opportunistic Infections

23 OPPORTUNISTIC INFECTIONS There are many opportunistic infections that take advantage of a weakened immune system. There are also co-morbid illnesses that can be worse when the immune system is weak. What are some of these?

24 Hepatitis There are many type but the most common are Hepatitis A, B and C Hepatitis is a liver inflammation caused by one or more virus A- is spread by the anal oral route ( this can be by direct contact or through food and water, unwashed hands etc.) B & C are spread through an infected person s body fluid, often during sex or sharing needles

26 TB Tuberculosis is an infection caused by bacteria. It usually affects the lungs, but sometimes can affect other organs, especially with people who are HIV+ with CD4 cells <200. The rate of TB for people with HIV in the US is 40 times that rate of those who aren t HIV infected. S/S may include: coughing, weight loss, fatigue, night sweats, and fever. It is transmitted through the air when someone with TB coughs or sneezes.

27 Treatment Treatment of HIV and TB is difficult, and not started at the same time because of overlapping drug toxicities, drug interactions and the need for strict adherence. TB is treated first then HIV meds 4-8 weeks after unless the persons CD4 is <50.

28 Diagnosis PPD / TST - skin test should be done when a person is first into care for HIV. Annual testing should be considered if there is an increased risk, residents of prisons or jails, IVDU, homeless individual or exposure.

29 CD4 count (cells/mm 3 ) CD4 Cell Count and Risk for Opportunistic Infections Thrush Oral hairy leukoplakia Tuberculosis Herpes Zoster Years after Infection Pneumocystis carinii pneumonia Cryptosporidial diarrhea M. avium complex Cytomegalovirus Infection Toxoplasmosis gondii Cryptococcal meningitis Microsporidial diarrhea Luber AD. Applied Therapeutics, Chapter 69; 2005.

30 What do shingles look like?

31 THRUSH Oral Candidiasis or thrush usually appears a white plaques that can be removed, revealing an erythematous mucosal surface or base. Other oral lesions such as Herpes simplex can cause small vesicles. Hairy leukoplakia most often presents as white patches usually seen on the tongue.

34 Odynophagia and HIV Pain on swallowing is a common complaint among patients with HIV/AIDS. Broad differential: Candida esophagitis, major aphthous ulcer, Herpetic or CMV esophagitis, GERD, pill induced. Presence of oral thrush has a high positive predictive value (> 90%) for candida esophagitis, while absence of thrush has a high negative predictive value (85%).

36 CD4 Lymphocytes Pneumocystis carinii pneumonia (PCP) Disseminated Histoplasmosis Toxoplasmosis Kaposi's Sarcoma Cervical cancer

40 Kaposi s Sarcoma

41 Cytomegalovirus (CMV) Retinal Disease Manifestation of advanced AIDS with CD4 almost always < 50. Initial complaint is often unilateral decrease in visual acuity, floaters or visual field defects. Diagnosis with a dilated exam by an ophthalmologist (lesions are often peripheral; nondilated exam only visualizes 4% of the retina).

43 Mycobacterium Avium Complex Atypical mycobacteria commonly found in the environment. 20% of tap water and 50% of potting soil samples. Symptoms include fever, night sweats, weight loss, diarrhea and abdominal pain. Suggestive lab and PE findings: severe anemia, elevated alkaline phosphatase and hepatomegaly.

44 DIARRHEA Can be a result of many different causes: such as diet, medications or HIV wasting. It can be a result of Bacterial infections, Parasites, Invasive diseases and cancers. The most likely cause would be the parasitic protozoa, Cryptosporidiosis which causes massive diarrhea.

45 Prevention of Opportunistic Infections (OI s) Pneumocystis carinii Pneumonia (PCP) TMP-SMZ DS (Bactrim, Septra) one tab once a day for CD4 <200, prior PCP or thrush. Mycobacterium avium complex (MAC) Azithromycin 1200mg, once a week or Biaxin 500mg, twice a day for CD4 <50

46 Screening Studies RPR Annual, more freq. if indicated Pap Smear baseline and at 6 months, then annual, if wnl STD testing TST/PPD (No anergy testing) - Annual, if at risk. Screen for HCV, HepB, HepA Toxoplasma IgG

47 Immunizations for HIV Pneumovax- all patients, booster every 5 years Hepatitis B - all patients with negative HepBcAb, or neg. HepBsAb. Influenza - all patients annually Hepatitis A - Hepatitis C patients who are not immune to Hepatitis A or all at risk Tdap - every 10 yrs Avoid live virus vaccines (MMR can be given when the immune cells are still strong), Varicella, Yellow Fever) *****

48 Can HIV+ patients get immunizations? Yes Pneumococcal Pneumonia Influenza Hepatitis B & A Tetanus / Tdap MMR (children**) NO! Smallpox - live virus - HIV+ patients should avoid contact with virus AND those immunized for 3 weeks Chicken pox

49 The Role of STD Detection and HIV Prevention Testing and treating STDs can be an effective tool in preventing the spread of HIV. Individuals that are infected with STDs are at least 2-5 times more likely that those uninfected to acquire HIV if they are exposed via sexual contact. Increased susceptibility portal of entry. Increase infectiousness shed HIV in genital tract and increase risk of transmission.

50 Areas of Focus in Partnership Follow trends of the epidemic; who is at risk. HIV testing for those at risk. Provide encouragement, support and adherence education. Be aware of Drug side effect profiles and drug interactions. Begin screening labs and send results with referral.

Clinical Manifestations of HIV

HIV Symptoms Diane Havlir, MD Professor of Medicine and Chief, HIV/AIDS Division University of California, San Francisco (UCSF) WorldMedSchool; July 2, 2013 1 Clinical Manifestations of HIV! Result from