Male Fertility Home Test Kit

Main technical information of this SP10 test kit is listed in the following table:

Former Cat. No.:	SPM 122
Description:	Male Fertility Home Test Kit
Category:	Immunological Infertility
Style:	Card
Unit:	PCS
Specimen:	Semen
No. of Step:	One Step
Reading Time:	15 Minutes
Cut Off:	1.5*107 units/mL
Specification:	4.0 mm
Quan. or Qual.:	Qualitative
Sensitivity:	98.3%
Specificity:	97%
Assay Principle:	Colloidal Gold Chromatographic Immuno Double Antibody Sandwich

The standard kit size of this Sperm Count Card Test Kit is 2 tests per box; 140 boxes per carton.

To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.

Tests per Kit:	2 Tests
Dimension of Kit Box:	16.5 * 6.5 * 5.0 CM
Boxes per Carton:	140 Kits
Tests per Carton (BULK):	1000 Tests
G.W. per Carton (Boxed):	8.5 KG
G.W. per Carton (Bulk):	15.0 KG
Carton Dimension:	53 * 44 * 35 CM
Carton Volume:	0.082 CBM

Materials Provided

• Test Cassettes (2×)
• Assay Diluent Dropper (2×)
• Disposable Specimen Container (2×)
• Disposable Specimen Transfer Pipette (2×)
• Instruction for Use (1×)

To carry out the assay with a Male Fertility Home Test Kit, Semen should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.

Semen Collection

Wait at least 48 hours, but not more than 7 days since the last ejaculation. Obtain semen specimen by manual stimulation (masturbation) or other proper ways. Ejaculate the specimen directly into a clean and dry container without losing any portion of the semen.

Lay the container on flat platform for about 1 hour at room temperature until semen specimen turn into liquid.

Gently stir the semen specimen with transfer pipette in the specimen container about 10 times until it is well mixed.

With specimen transfer syringe, transfer 100 μL semen specimen into assay diluent dropper which contains 2 mL assay diluent. Try to avoid any solid or sticky material, and avoid forming air bubbles syringe. If this happens, push the semen back out completely and then draw semen again.

Close the cap of assay diluent dropper, shake the diluent dropper at least 10 times to guarantee specimen well mixed with solution and place it on a flat platform for 2min.

Twist off the cap of the assay diluent dropper prepared from the SAMPLE PREPARATION, transfer 3 drops of specimen processing solution (80-100μL) vertically into the cassette sample well (S sign).

Place the cassette at room temperature for 15 minutes, and read the test result.

Semen Storage Condition

The semen specimen should be tested within 3 hours after collection.

Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this Male Fertility Home Test Kit to detect the SP10 Protein in human Semen specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.