rapid hiv testing oraquick advance hiv 1/2

RAPID HIV TESTINGOraQuick

ADVANCE HIV 1/2

WellOne Primary

Medical and Dental Care for Medical Clinical Staff

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OraQuick ADVANCE Rapid HIV Testing : AT WELLONE

Oraquick Rapid HIV Testing can be processed using a blood specimen or oral specimen- At WellOne, we use only blood for specimen processing

The test is not approved for persons under age 13Testing should be offered to all persons age 13 to 64 routinely

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http://www.cdc.gov/hiv/topics/testing/resources/factsheets/rt_counseling.htm

TRUE or FALSE: OraQuick Advance Rapid HIV testing is not approved for

persons under age 16 True

False

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answerClick here to select this

answer

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The correct answer is FALSE

The test is not approved or persons

under age 13Click here

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The OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test kit consists of:•A divided pouch containing a test device and a developer solution vial•Reusable test stands•Collection loops•Subject information pamphlet•Package insert.



Oraquick Rapid HIV Testing : Storage & StabilityTest Kits

At WellOne, kits are stored in the laboratory unrefrigerated

The laboratory room temperature must be monitored daily. If the temperature is out of acceptable storage range (35-80º F), notify your supervisor immediately

ControlsControls are stored refrigerated at 2-80 C (35-460 F) Do not use controls past the expiration date printed on the outer carton. Open control vials only when you are performing tests.Recap and store the vials in their original container at 2-80 C after use. Date the controls with the date opened and “do not use after” date.Opened vials expire 8 weeks after opening. The temperature of the biological fridge is checked daily. Action is to be taken if results are out of range. Do not use controls if the reagent appears visually cloudy or discolored. Practice standard precautions when handling controls.



TRUE or FALSE: The OraQuick control solution is good for 8 weeks after

receiving the solution True

False



answer



The control solution is stable until the expiration date when

stored in the refrigerator at appropriate temperatures. After opening, the control

solution expires in 8 weeks from the date first opened.



The laboratory room temperature and refrigerator temperature must be checked and documented by the MA:

Weekly

Monthly

Daily


answer


answer


answer


The correct answer is….

DAILY



HIV TESTING: EXTERNAL CONTROLSExternal Controls (three total) including and HIV 1 positive, HIV 2positive, and HIV 1/2 negative control will be run and recorded onQA form: • With each new lot of test packs received prior to placing them

in service• If there is a change in the conditions of testing (e.g. new

location, lighting, temperature, etc.)• If the temperature of the test storage area falls outside of 2-

270C (35-800F)• If the temperature of the testing area falls outside of 15-270C

(59-800F)• Monthly (May change depending on testing volume)• Whenever two consecutive invalid test results are obtained on

a person being tested.

Click here to see the control

test package insert



http://www.fda.gov/CBER/pmalabel/P01004716kit.pdf

The OraQuick ADVANCE® controls should be run in each of the following situations except:

When a new lot ofOraQuick ADVANCE® kits arereceived.

If there is a change inconditions of the storagearea.

By each operator at thestart of a shift.


answer


answer


answerClick here to go back

The correct answer is……….

By each operator at the start of a shift.

External control testing must be performed when a newlot of OraQuick ADVANCE® kits are received and if there isa change in conditions of the storage area.



WARNING

Conducting this test exposes the operator to potentially infectious material. Standard precautions, including glove use are required for this procedure.

HIV controls are potentially infectious and should be handled in the same manner as a patient specimen, using all appropriate precautions.



http://wfldelearn.pssd.com/BinderView_PSS/vault/006/006863.pdf

Testing Procedure

– Identify patient using two patient identifiers (name and DOB)– Explain procedure to patient in culturally appropriate, age appropriate

terms. – Be sure the patient has received an OraQuick Advance Subject Testing

Information Pamphlet.– Gather all necessary equipment and supplies prior to start of the

procedure.– Inspect all equipment and supplies for damage, general integrity and

expiration date- do not use any damaged or expired materials– Perform hand hygiene before and after patient contact; before and

after donning gloves.



Open the divided pouch. Using the notched corners, tear the top of each end of the divided pouch containing the test device and developer solution vial. Remove the developer solution bottle. To prevent contamination, leave the Test Device in the divided pouch until needed.

Flat Pad: Do NOT Touch



Don gloves. Remove the Developer Solution Vial from the Divided Pouch.Firmly holding the Developer Solution Vial, carefully uncap the vial by gently rocking the cap back and forth. Slide the uncapped Developer Solution Vial into the top of the slot in the angled Reusable Test Stand.

Place the Reusable Test Stand on a flat, level surface. Use only the stand provided.

Be sure the vial is completely seated in the stand. DO NOT Force the

vial into the stand from the front of the slot, as

splashing may occur.



Testing ProcedureFollow finger stick procedureUse the Specimen Collection Loop and collect the blood on the rounded end of the loop, making sure the loop is completely filled with blood. Immediately immerse the blood-filled Specimen Collection Loop in the developer solution inside the Developer Solution Vial. Use the Specimen Collection Loop to stir the specimen in the developer solution. Remove the Specimen Collection Loop from the Developer Solution Vial and discard the used loop in a biohazard waste container. Examine the solution in the Developer Solution Vial to ensure that it appears pink, indicating that the blood specimen was properly introduced. If the developer solution is not pink after adding the specimen, discard the Developer Solution Vial as infectious waste, open a new Divided Pouch, and collect a new specimen.



Testing ProcedureRemove the Test Device from the Divided Pouch without touching the flat pad. Insert the Test Device, flat pad first, into the Developer Solution Vial containing the specimen. Be sure that the result window faces forward and the flat pad touches the bottom of the Developer Solution Vial.

Label the specimen with the patient’s initials and DOBDO NOT cover the two holes in the back of the Test Device after placing it into the developer solution. Doing so may cause an invalid result



Begin Timing and Documenting SET THE TIMER

FOR 20 MINUTES

Document on the HIV testing log:

Date of testing Patient name

DOBTime Test was StartedTemperature of room where testing is being

doneClick here


Read and Document Results

RESULTS MUST BE INTERPRETED

NO EARLIER THAN 20

MINUTES and NO LATER THAN 40 MINUTES after introducing the

specimen into the developer solution.

CORRECT TIMING OF

INTERPRETATION IS CRITICAL



10; 2020; 6020; 40

OraQuick ADVANCE® results must be interpreted at no less than _______minutes and no more than _______minutesafter introducing the specimen into the developer solution.




answer


10; 2020; 6020; 40

The Correct Answer Is……………..




answer

RESULTS MUST BE INTERPRETED NO EARLIER THAN 20 MINUTES and NO LATER THAN 40 MINUTES after introducing the specimen into the developer solution.



Read and Document Results

After recording results, dispose of the test vial and test device in the biohazard waste container.



Rapid HIV Testing: Internal Control ResultAn internal control is built into the test unit.

A line appears at the “C” (control) , indicating a valid test

This is read as “control is positive”



Rapid HIV Testing: Internal Control ResultAn internal control is built into the test unit.

If the control line does not appear, the test is not valid and must be repeatedThe lack of a control line may mean that an insufficient amount of blood has been added to the test device or the test device is not working



Rapid HIV Testing: Negative (Nonreactive) Test Result This is a negative test with

no line appearing at the “T” on the testing unit and a positive control line appearing at the “C”



Rapid HIV Testing: Negative Test Result

A Non-Reactive result does not preclude the possibility of exposure to HIV or infection with HIV.An antibody response to recent exposure may take several months to reach detectable levels. Rule out a history of exposure to HIV within 3 months. Recommend a retest for clients with a recent exposure.



Rapid HIV Testing: Positive (Reactive) Test ResultVV

The intensity of the test line does not correlate with disease activity/severity.All OraQuick reactive (preliminary positive) results must be followed up with either a Western Blot (WB) for confirmation.Whenever the OraQuick® test result is reactive, the Health Care Provider must explain the results to the patient and provide the patient with a confirmatory testing lab slip to be performed at the lab. A follow up appointment must be scheduled to review the results with the patient.The health care provider must indicate on the specimen requisition form that the specimen is from an individual who had a reactive OraQuick rapid test result. Click here


TRUE or FALSE - The intensity of the color of the line next to the “T” zone that appears during a test signifies

the amount of HIV antibodies in the specimen. True

False



answer



The intensity of the test line does not correlate with disease activity/severity.



TRUE or FALSE: A Western Blot must be ordered for preliminary positive results

True

False



answer


The correct answer is TRUE• A Western Blot (not an ELISA) must be

ordered as confirmatory testing.• Be sure to indicate on the specimen

requisition form that the specimen is from an individual who had a reactive OraQuick rapid test result.



Rapid HIV Testing: Invalid Test ResultsNo line is present in the area adjacent to either the “C” or “T” triangle (figure 1)A line appears opposite the “T” triangle but not the “C” triangle (figure 2)A red background in the result window makes it difficult to read the results after 20 minutes (figure 3)A line appears, but not opposite the “C” (or “T”) triangle – misalignment

(figure 4)



Which of the following is an example of an invalid test result using an OraQuick ADVANCE® test kit?

No line is present in the areanext to either the “C” or “T”triangle.

A line appears opposite the “T” triangle butnot the “C” triangle.

The pinkish red background in the resultwindow does not disappear and makes itdifficult to read the result after 20 minutes.

All of the above.



answerClick

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answer


The Correct Answer is……

All of the above



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