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CD4 STATUS
Rapid Diagnostic Screening Test for the assessment of Immune Status in HIV/AIDS Patients through Semi-Quantitative Detection of Specific Protein that Directly Correlates to CD4 Counts (CD4 Equivalents)in human Plasma or Serum Samples
“US AND FOREIGN PATENTS PENDING”
Introduction:
Amgenix International, Inc., USA has developed a novel rapid diagnostic test to determine the immune status of HIV/AIDS patients in resource poor settings so that the need for anti-retroviral therapy can be established or to identify those whose current treatment may need changing.
The Test:
The OnSight™ – CD4 STATUS One-Step Test measures proteins that correlate to CD4 counts. The test, which is a VISUAL assay, employs a test line with a cutoff, which is subject to some degree of interpretation by the user as to when the test line disappears which is indicative of a negative result. As it is difficult to have an exact cutoff point using lateral flow technology, the tests stated cutoff is actually in a range, in this case equivalent to a CD4 count of 200 +/- 25 CD4 cells which is where the test line signal will in most cases disappear from the OnSight™ – CD4 STATUS test device. Based on outside evaluations to date, the OnSight™ – CD4 STATUS Test is showing a correlation of approximately 89 percent versus flow cytometry. It is also important to understand that there is a fair degree of variation in test results from one brand of flow cytometer to another brand even when using the same test sample and from one CD4 count to another CD4 count even on the same sample when using the same equipment so any comparison of results between theOnSight™ – CD4 STATUS Test and flow cytometry should take into account that variation.
Test Results for the OnSight™ – CD4 STATUS Test:
Sample Number |
CD4 Count |
Viral Load |
OnSight™ – CD4 STATUSTest Type |
OnSight™ – CD4 STATUSTest Results |
Date Run |
|
|
|
|
NOTE: |
|
0005-041-01472 |
1000 |
|
OS200 |
Positive |
07/01/07 |
0006-041-01825 |
225 |
|
OS200 |
Negative |
07/01/07 |
0008-041-00640 |
174 |
|
OS200 |
Negative |
07/01/07 |
0008-214-02462 |
528 |
|
OS200 |
Positive |
07/01/07 |
0009-041-01357 |
354 |
|
OS200 |
Positive |
07/01/07 |
0006-041-00754 |
994 |
63 |
OS200 |
Positive |
09/05/07 |
0008-041-01001 |
599 |
188 |
OS200 |
Positive |
09/05/07 |
0008-214-02455 |
200 |
5730 |
OS200 |
Positive |
09/05/07 |
0009-041-01333 |
554 |
<25 |
OS200 |
Positive |
09/05/07 |
0009-041-01345 |
376 |
<50 |
OS200 |
Positive |
09/05/07 |
0010-258-02458 |
400 |
1640 |
OS200 |
Positive |
09/05/07 |
0006-041-01826 |
402 |
<50 |
OS200 |
Positive |
09/24/07 |
0009-096-01781 |
451 |
800 |
OS200 |
Positive |
09/24/07 |
0009-214-01609 |
501 |
<50 |
OS200 |
Positive |
09/24/07 |
0010-214-00041 |
456 |
15679 |
OS200 |
Positive |
09/24/07 |
0005-041-01454 |
278 |
13211 |
OS200 |
Positive |
11/06/07 |
0005-041-01695 |
301 |
6629 |
OS200 |
Positive |
11/06/07 |
0006-041-00772 |
254 |
26801 |
OS200 |
Positive (very weak) |
11/06/07 |
0006-041-01524 |
256 |
<50 |
OS200 |
Positive (very weak) |
11/06/07 |
0007-041-01775 |
205 |
70 |
OS200 |
Negative |
11/06/07 |
0008-041-00993 |
226 |
4972 |
OS200 |
Negative |
11/06/07 |
0009-214-01940 |
301 |
39652 |
OS200 |
Positive |
11/06/07 |
145719 |
1165 |
N/A |
OS200 |
Positive |
10/08/07 |
145721 |
920 |
N/A |
OS200 |
Positive |
10/08/07 |
145723 |
1012 |
N/A |
OS200 |
Positive |
10/08/07 |
145725 |
578 |
N/A |
OS200 |
Positive |
10/08/07 |
145726 |
641 |
N/A |
OS200 |
Positive |
10/17/07 |
146106 |
923 |
N/A |
OS200 |
Positive |
10/17/07 |
146108 |
880 |
N/A |
OS200 |
Positive |
10/17/07 |
IN 01 |
457 |
N/A |
OS200 |
Positive |
12/06/07 |
IN 02 |
142 |
N/A |
OS200 |
Positive (very weak) |
12/06/07 |
IN 03 |
304 |
N/A |
OS200 |
Positive |
12/06/07 |
IN04 |
604 |
N/A |
OS200 |
Positive |
12/20/07 |
IN05 |
287 |
N/A |
OS200 |
Negative |
12/20/07 |
IN06 |
99 |
N/A |
OS200 |
Positive (very weak) |
12/20/07 |
IN07 |
214 |
N/A |
OS200 |
Positive (very faint) |
12/20/07 |
IN08 |
537 |
N/A |
OS200 |
Positive |
12/20/07 |
IN09 |
634 |
N/A |
OS200 |
Positive |
12/20/07 |
IN10 |
225 |
N/A |
OS200 |
Positive (weak line) |
12/20/07 |
IN11 |
32 |
N/A |
OS200 |
Positive |
12/20/07 |
IN12 |
171 |
N/A |
OS200 |
Positive (very faint line) |
12/20/07 |
IN13 |
193 |
N/A |
OS200 |
Positive (very faint line) |
12/20/07 |
IN14 |
395 |
N/A |
OS200 |
Positive |
12/20/07 |
IN15 |
384 |
N/A |
OS200 |
Positive |
12/20/07 |
IN16 |
103 |
N/A |
OS200 |
Negative |
12/20/07 |
IN17 |
639 |
N/A |
OS200 |
Positive |
12/20/07 |
SA1 |
133 |
N/A |
OS200 |
Positive |
03/10/08 |
SA2 |
176 |
N/A |
OS200 |
Positive |
03/10/08 |
SA3 |
211 |
N/A |
OS200 |
Positive |
03/10/08 |
SA4 |
222 |
N/A |
OS200 |
Positive |
03/10/08 |
Results in RED are discordant
All results at 200 +/- 25 CD4 cells were considered positive based on the tests low end cutoff
N = 50
Correlation to Flow Cytometry = 89.1 %
Please Note:
Results for the OnSight™ – CD4 STATUS Test are reported as either Positive when a colored band of any intensity is seen in the Test area of the device or Negative when no colored band is visible in the Test area. As the amount of CD4 Equivalent proteins approaches the dynamic cutoff for the test which is approximately 200 +/-25 CD4 cells, the colored band in the Test area of the device will become lighter and lighter until it disappears at approximately 200+/-25 CD4 cells
Conclusion:
The OnSight™ – CD4 STATUS Test is producing results so far that would indicate the test would be clinically useful in determining the immune status of an HIV/AIDS infected person in resource poor settings where standard tests such as flow cytometry are; unavailable, unaffordable or where the need for test results are time sensitive.
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