DRG RAP-4808 Rapid Screen Test Instruction Manual
- June 15, 2024
- DRG
Table of Contents
Instructions for Use
PMSG (Horse)
Rapid Screen Test
Please use only the valid version of the Instructions for Use provided with
the kit.
For the detection of PMSG in serum or plasma samples of mare between 40 – 120
days after fertilization to confirm pregnancy
INTRODUCTION
PMSG (Pregnant Mare Serum Gonadotrophin) is a glycoprotein hormone secreted by
a part of the foetal placenta called endometrial cups. It stimulates and forms
additional corpora lutea.
In pregnant mares, PMSG is usually first detectable in blood between 35 and 40
days of gestation, rise rapidly to peak about 60 days, then decline slowly to
become undetectable at about 140 days of gestation. After 140 days the PMSG
level decreases rapidly when the placenta starts producing the necessary
amount of progesterone to maintain pregnancy.The PMSG (Horse) Rapid Screen Test (One-
step test) as a means of pregnancy testing is a suitable and easy to use
method to confirm earlier ultrasound scanning techniques and allows the
practitioner to obtain this information quickly.
This test detects levels of ± 10 IU.
The test uses an inhibition principle.
A weak signal means PMSG level is between 35 -65 IU.
No signal means a PMSG level higher than 65 IU.
INTENDED USE
This One-Step Test is intended to use as practical/routine screening test that can be done in a few minutes. This test kit is designed to detect PMSG by use of a blocking rapid immunochromatic assay.
PRINCIPLE
The PMSG One- Step Test is based on the blocking principle for the detection
of PMSG. Anti-PMSG is conjugated to colloidal gold particles and the PMSG is
immobilized on the strip in the test zone “T”. PMSG in a sample that is
applied to the strip at the sample zone “S” will bind to the gold particles
which then migrate to zone “T”. No colour change in zone “T” indicates a
positive test.
Labelled colloidal gold particles are also immobilized on the test strip in
the control zone “C”, to indicate that the test is working properly.
CONTENTS
6 or 24 pouches, each containing 1 test strip and 1 pipette
6 or 24 vials containing buffer
1 Instructions for Use
HANDLING AND STORAGE OF REAGENTS/SPECIMENS
The test should be stored at room temperature (± 21 °C).
An unopened package can be used until the expiry date.
An opened package must be used immediately.
If the conditions are no longer fulfilled the test can no longer be used.
Avoid freezing and heating as this will contribute to destruction of the test.
Samples may be used fresh or may be kept frozen below -20 °C before use.
SAMPLE MATERIAL
It is advised to test fresh serum or plasma samples.
Do not use haemolytic or lipaemic serum.
PRECAUTIONS
− Handle all biological materials as though capable of transmitting infectious
diseases.
− Do not pipette by mouth.
− Do not eat, drink, smoke, prepare foods or apply cosmetics within the
designated work area.
− Do not use components which passed the expiry date and do not mix components
from different serial lots together.
− Optimal results will be obtained by strict adherence to this protocol.
Careful pipetting and sampling throughout this procedure are necessary to
maintain precision and accuracy.
− Each test strip is ultimately used as an optical reference. Therefore, do
not touch the surface of the test strip and protect it from damage and dirt.
TEST PROTOCOL
-
Unpack the test strip and pipette.
Only open the amount of pouches to be used. An opened package should be used immediately. -
Add 2 drops of serum/ plasma to the buffer vial by using the pipette (Figure 1).
-
Mix well by using the pipette (Figure 2).
-
Add 4 drops of the buffer vial containing the sample, with the included pipette slowly to the sample zone “S” (Figure 3).
-
Read the result after 25 – 45 minutes (for the interpretation of the test result see chapter 10 and chapter 11).
VALIDATION OF THE TEST
To validate this Rapid Screen test a control line should always be visible at
control zone “C”.
If no control line is visible the test should be considered invalid.
Results should be read in the given time. Results read after the given time
should be considered invalid.
Invalid tests should be repeated with a new test.
INTERPRETATION OF TEST RESULTS POSITIVE:
Only one line is visible in zone “C” (Figure A). The sample contains PMSG.
Positive results may vary in optical density due to variations in antibody
concentrations in the sample.
WEAK POSITIVE:
Two lines are visible, a weak line in zone “T” and a line in zone “C” (Figure
B). The sample contains low concentrations PMSG.
The intensity of line “T” will vary depending on the concentration of PMSG in
the sample.
NEGATIVE:
Two lines are visible in zone “T” and zone “C” (Figure C). The sample does not
contain PMSG.
NOT VALID:
No band is visible in zone “C” (Figure D). Repeat the test procedure.
The
entire risk as to the performance of these products is assumed by the
purchaser. DRG shall not be liable for indirect, special or consequential
damages of any kind resulting from use of the products. In case of problems or
questions contact DRG.
SYMBOLS USED
Symbol|
---|---
| Consult instructions for use
| Catalogue number
| Batch code
| Contains sufficient for
| Temperature limit
| Use-by date
| Manufacturer
| Caution
| For research use only
| For veterinary use only
Distributed by| Distributed by
Content| Content
Volume/No.| Volume / No.
Version 4.0;
2023-02-27 – vk RAP-4807
24 tests
RAP-4808
6 tests DRG Instruments GmbH, Germany
Frauenbergstraße 18, 35039 Marburg
Phone: +49 (0)6421-1700 0, Fax: +49 (0)6421-1700 50
Website: www.drg-diagnostics.de
E-mail: [email protected]
Distributed by:
DRG International, Inc., USA
841 Mountain Ave., Springfield, NJ 07081
Phone: 973-564-7555, Fax:
973-564-7556
Website: www.drg-international.com
E-mail: [email protected]