Serology Accreditation Validation Study 1 - February 2008

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Purpose: To validate SSDI laboratory semen detections by performing three separate tests. The first two consist of chemical testing 20 vaginal swabs containing a controlled semen standard. Test number one is for Prostate Specific Antigen (PSA). PSA is a glycoprotein produced by the prostate gland and secreted in seminal fluid at concentrations (from 2.0x105 to 5.5x106 ng/ml). Test number two is to detect Acid Phosphatase (AP). AP is an enzyme present in semen at concentrations of 20 to 400 times other body fluids. The presence of AP is a presumptive test for the presence of semen. The third test is a physical microscopic examination for whole spermatozoa.

Twenty vaginal swabs (Seri part number R675D lot 0903114) with semen standard (Seri part number R563 lot 759) diluted to the following concentrations.

Serological Research Institute Semen Standard R563
Swab Number	Concentration ng	Dilution	Swab Number	Concentration ng	Dilution
1	10,000	Undiluted	11	9.765625	1:1,024
2	5000	1:2	12	4.8828125	1:2,048
3	2500	1:4	13	2.44140625	1:4,096
4	1250	1:8	14	1.220703125	1:8192
5	625	1:16	15	0.610351563	1:16,384
6	312.5	1:32	16	0.305175781	1:32,766
7	156.25	1:64	17	0.152587891	1:65,536
8	78.125	1:128	18	0.076293945	1:131,072
9	39.0625	1:256	19	0.038146973	1:264,144
10	19.53125	1:512	20	0.019073486	1:524,288

Test Results
Swab #	DTC0220 PSA	ABAcard PSA	AP	Swab #	DTC0220 PSA	ABAcard PSA	AP
1	Positive	N/A	Positive	11	Positive	N/A	N/A
2	Positive	N/A	Positive	12	Positive	Positive	N/A
3	Positive	N/A	Positive	13	Positive	Positive	N/A
4	Positive	N/A	Positive	14	Positive	Positive	N/A
5	Positive	N/A	Positive	15	Positive	Negative	N/A
6	Positive	N/A	Positive	16	Positive	Negative	N/A
7	Positive	N/A	Positive	17	Negative	N/A	N/A
8	Positive	N/A	Negative	18	Negative	N/A	N/A
9	Positive	N/A	Negative	19	Negative	N/A	N/A
10	Positive	N/A	N/A	20	Negative	N/A	N/A

AP -Acid Phosphatase
N/A Not Applicable (no reason to test)

PSA and AP Test Result Photographs
(Select picture for full size)

Conclusions: Prostate specific antigen can be detected from the undiluted range of 10,000 ng to a diluted range as low as 0.305175781 ng. Acid phosphatase can be detected from the undiluted range of 10,000 ng to a diluted range as low as 78.125 ng. The microscopic inspection was negative because there were no sperm heads contained in the semen standard.

Reproducibility and Precision: In order to determine reproducibility and precision, a positive control sample was tested ten times by PSA and AP in the following tests:

Test Number	Case Number	Result
1	AP00514	POS
2	AP00683	POS
3	AP40810	POS
4	AP40947	POS
5	AP51525	POS
6	PSA61715	POS
7	PSA51928	POS
8	PSA71931A-C	POS
9	PSA71950	POS
10	PSA81988	POS

The reproducibility and precision of microscopic inspection is accomplished by confirming the presence of whole sperm heads mounted on a positive control sample Christmas tree stained slide (Kernechtrot-Picroindigocarmine Stain).