Q&A for Aware™ HIV-1/2 OMT

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Q: What if there is no control line but there is a test line?

A: The result is defined as an invalid test. In order for the control line to be present, the test must be run correctly andthere must be sufficient sample present in the buffer. IgG in the specimen binds at the control line causing a reddish colored line to appear. Retest with a new strip and buffer tube ensuring that the specimen is thoroughly mixed into the buffer.

Q:What if the test ran but there are no lines?

A: If liquid sample migrated up the test but no lines appear, the result is defined as invalid.  There are a number of reasons why there would be no lines present:

the sample was not collected correctly or mixed with the buffer properly (or inadequate sample was collected); the test strip did not function correctly (e.g. the pouch was damaged and the strip was previously exposed to moisture); the test was not kept at proper temperature during storage; the test was used beyond its expiration date;
Regardless of the cause, you must retest with a new test strip using a new buffer tube and specimen.


Q: What if the test did not appear to run (no liquid migrated up the test)?

A: The two most common causes of a test failing to run are if the strip is placed into the specimen upside down or the strip has been placed into a tube that does not have a specimen.  Insure that the strip has been placed with the arrows pointing down into a tube with specimen.


If the strip was placed into a specimen correctly, then a less common cause of a strip not running is if there has been an interruption in the overlapping of materials in the strip. Occasionally, if the strip was not handled carefully while it was being removed from the package, the interface of the various strip components to one another can get interrupted.  Carefully remove a new strip from its package and retest a fresh specimen.

Q:The membrane appears to have more red on the edge. What does that mean?

A: This is not of concern as long as the areas where the lines form are relatively clear. This phenomenon can be caused by non-uniform sections within the membrane where the flow is faster or slower than other sections.  If in doubt, you should allow the strip to continue to run the full 45 minutes and then read the result. Often, the strip will clear up after some time has elapsed to allow all of the gold conjugate to be released from the conjugate pad.

Q:The membrane appears to have a pinkish red color. Is that OK?

A: Yes. This phenomenon is called background and happens because the conjugate/sample is continuing to migrate up the strip. Occasionally, some specimen attributes will cause a clearing of the conjugate/sample that is slower than usual.  In these cases, you should allow the strip to continue running the full 45 minutes. The strip should eventually clear as the conjugate/sample is drawn into the wick. Results from test strips with background are valid provided the control line is present.

Q:What if one or both of the test and control lines are incomplete?

A: Sample attributes can sometimes cause minor interruptions in the line.  If a majority of the line is present, the specimen is considered reactive.  In the rare event that there is color on only a minor portion of the line, the test should be rerun.

Q:Why does the test or control line appear thicker than the diagram in the instructions?

A: Sometimes, a highly reactive specimen or a specimen with high levels of IgG can generate a thick line at the test or control line, respectively.  Test results where a thick line is present are considered valid.

Q: Why does the test or control line appear thinner than the diagram in the instructions?

A: Sometimes, a weakly reactive specimen or a specimen with low levels of IgG can generate a thin line at the test or control line, respectively.  Test results where a thin line is present are considered valid.

Q:I dropped the strip on the floor. Can I still use it?

A: No. Due to possible contamination, it is best to test with a new strip.

Q:While processing the specimen, a small amount of fluid spilled out. Can I still run the test?

A: See the next question and answer.

Q:While taking the cap off the tube, a small amount of fluid spilled out.  Can I still use the tube?

A: Both questions #10 and #11 depend upon the amount of loss.  The test will still run with as little as 0.2 mL of sample.  You will see a delineation where the curved bottom of the buffer tube starts; that mark represents a volume of approximately 0.2 mL (200 µL). If the buffer level is at that line or above after the swab has been mixed with the buffer and removed, there is sufficient buffer volume to run the test.

Q:While removing the strip from the package, I accidentally touched the membrane. Can I still use it?

A: Although the test strip is very robust and touching the membrane usually is not a problem, it is possible that oils or dirt from your finger may have contaminated the strip. If in doubt, you should use a new test strip.

Q:What if I see a strong line develop before 20 minutes.  Do I have to wait the entire time period?

A: Yes. The test is designed to be read between 20 and 45 minutes. The test should not be evaluated before 20 or after 45 minutes.  It is possible that if you read the results before 20 minutes you will get an incorrect result.

Q: Can I read a test after 45 minutes?

A: No. The test is designed to be read between 20 and 45 minutes. Ensure adequate time before running a test.  It is possible that if you read the results after 45 minutes you will get an incorrect result.

Q:Can I use a strip from a different Calypte product such as the blood or urine test kits to test an oral fluid sample?

A: No. Each test platform is designed to function within the test parameters of that specific sample type.

Q:Are panels or controls available for training purposes?

Yes. Calypte has a set of positive and negative controls (one of each) as well as a Proficiency Panel made up of various specimens  including negative, invalid and several positives from a dilution series where the results change from positive to negative. Inquire with our Customer Service Department for further details (call: 1-877-225-9783, or e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ).

Q:Does the assay work for both HIV-1 and HIV-2?

A: Yes.  The test line contains both HIV-1 and HIV-2 antigens which will react with specimens containing HIV-1 antibodies, HIV-2 antibodies, or both.

Q:How should I confirm a positive result?

A: Consult with your public health authority in your area (country) for the approved testing algorithm. Different countries may have different requirements. Most approved algorithms use a confirmatory assay, such as an EIA, Western Blot assay or a different rapid test. 

Q:Does the swab have any treatments or taste?

A: No. Our unique swab has no displeasing taste or treatments of any kind.

Q:I recently ate or drank.  How long do I have to wait before I can collect and test a specimen?

A: Wait at least ten minutes after eating or drinking before collecting an oral specimen.

Q:I recently smoked a cigar/cigarette.  How long do I have to wait before I can collect and test a specimen?

A: You may test immediately after smoking without adverse effect on test results.

Q:Does the test work with children?

A: Limited data collected by other researchers suggest the test is suitable for testing children as young as two years old, however studies have not determined the accuracy in such a population.  Our clinical supporting data is based on studies conducted with adult (18 years of age and older) specimens.

Q:Should I have a person remove their dentures before collecting a specimen?

A: It is preferred that a denture wearer remove any dentures.

Q:I recently brushed my teeth.  How long do I have to wait before I can collect and test specimen?

A: You should wait at least ten minutes after brushing your teeth before collecting an oral specimen.

Q:I accidentally plunged the swab ten times instead of 6-8 times.  Is the test still valid?

A: Yes. We require the swab be plunged up and down at least 6-8 times in the buffer to fully release the oral fluid from the swab head.  Additional mixing will not adversely affect the results.

Q:How do I know if a valid specimen was collected?

 A: If there is an adequate amount of IgG in the specimen, there should be a distinct red-pink colored line in the control zone for a negative specimen.  This means that the specimen collected was valid and the test ran properly. 

 

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