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Serology Accreditation Validation Study 1 - February 2008 

EMAIL: Info@Semen-Detection.com for complete 10 page report

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)

DSCN2492.JPG (83388 bytes)DSCN2493.JPG (81208 bytes)DSCN2494.JPG (83793 bytes)DSCN2495.JPG (81932 bytes)DSCN2498.JPG (86653 bytes)

DSCN2497.JPG (82782 bytes)DSCN2505.JPG (84060 bytes)DSCN2502.JPG (81604 bytes)DSCN2503.JPG (82198 bytes)

 

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).