A rapid test for the qualitative detection of PSA for assessing
presence of Human Semen in vaginal fluid or other areas, where a
liquid/ stain is suspected to be semen. For forensic use only.
INTENTED USE
The Human Semen Rapid Test Dipstick is a rapid chromatographic
immunoassay for qualitative detection of PSA found in human semen
in vagina using swab specimen as an evidence for coitus or other
areas, where a stain/ liquid is suspected to be semen.
SUMMARY
Rape, as the criminal activity, exist every country. An examination
after rape requires the use of a reliable semen detection test that is
sensitive and has very good negative predictive power.1 the PSA test is the best
marker of the presence of semen and is well suited for use in emergency
consultations.
PSA (Prostate-specific antigen) is a glycoprotein produced in the
prostate and secreted into the seminal fluid. PSA is one of the major proteins
in seminal fluid. The fact that PSA is found only at very low concentrations
in female vaginal fluid (0.4-0.9 ng/mL and 0.0-1.25 ng/mL, respectively)2,3
makes PSA an important marker in forensic science for the detection of even
small amounts of seminal fluid in vagina to confirm coitus. Human Semen
Rapid
Test detects PSA to confirm the presence of semen in vaginal fluids
collected with the swab. The test just confirms the presence of PSA as a
result of seminal ejaculation, without any indication for coitus being forced
sexual assault (Rape) or consensual.
PRINCIPLE
The Human Semen Rapid Test Dipstick (Stain) is a qualitative,
lateral flow immunoassay for the detection of PSA found in human semen in
vaginal fluid. The membrane is pre-coated with PSA antibodies on the test line
region. During testing, the specimen reacts with the particle coated with
anti-PSA antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-PSA
antibodies on the membrane and generate a colored line.
REAGENTS
The test dipstick contains PSA monoclonal antibody conjugated
particles and PSA monoclonal antibody coated on the membrane.
PRECAUTIONS
Please read all the information in this package insert before
performing the test.
1. For forensic use only. Do not use after the expiration date.
2. The test should remain in the sealed pouch or closed canister
until ready to use.
3. Do not eat, drink or smoke in the area where the specimens or
kits are handled.
4. Do not use the test if the pouch is damaged.
5. All specimens should be considered potentially hazardous and
handled in the same manner as an infectious agent.
6. Wear protective clothing such as laboratory coats, disposable
gloves or eye protection when specimens are being tested.
7. The used test should be discarded according to local
regulations.
8. Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION AND PREPARATION
• The Human Semen Rapid Test Dipstick (Stain) can be performed
using soaking solution of uncertainty stain.
• Specimen collection from vagina: Before specimen collection,
remove excess mucus from the endocervical area with a cotton ball and
discard. The swab should be inserted into the endocervical canal, past the squamocolumnar junction until most of the tip is no longer visible.
Firmly rotate the swab 360°in one direction (clockwise or
counterclockwise), let stand for 15 seconds, then withdraw the swab. Avoid contamination
from exocervical or vaginal cells. Do not use 0.9% sodium chloride to
treat swabs
before collection specimens. Dispense the tip of the swab thus
obtained in a sterile cup of clean water (Approx. 30 ml water) and mix well by
rotating the swab for 10 times. Allow swab to be in the water for at least 2
minutes.
• Specimen collection from other sources: Place the sterile swab in
clean water for a while, then wipe the suspected place (liquefied or dry
stain) with the swab for 3 times, then place the moist swab into the water
(Approx. 30 ml water) and turn the swab in one position for 10 times. Allow
swab to be in water for at least 2 minutes. Alternatively, If the suspected
stain is on apiece of cloth, such as trousers or bed sheet, the cloth around the
stain can be cut out and put in the water kept for specimen collection
processing (Approx. 30 ml water).
• The Test Solution thus prepared with the mix of specimen obtained
through swab or cloth and water (Approx. 30 ml water) should be used as specimen for testing as soon as possible, best results would be
obtained within 1 hour of this Test Solution preparation.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test dipstick from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the Test Solution, immerse the test
dipstick vertically in the Test Solution for 10-15 seconds. DO NOT PASS THE
“MAX” LINE on the lower strip label of the dipstick when immersing the
dipstick.
3. Place the dipstick on a level and clean desk, start the timer
and wait for the color line (s) to appear. Read the result at 5 minutes, do not
interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the
control line region (C) and another apparent colored line should be
in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of human semen present in the
specimen. Therefore, any shade of color in the test line region (T)
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C).
No line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line
failure. Review the procedure and repeat the test with a new test.
If the problem persists, discontinue using the test kit immediately
and contact your local distributor.
Order Information
| Cat. No. | Product | Specimen | Pack |
| OHS-901 | Human Semen Rapid Test Dipstick | Stain | 50 T |
| OHS-902 | Human Semen Rapid Test Cassette | Stain | 40 T |
