One Step Male Fertility Sperm Concentration Test for Home Use Diagnostic Test Kits

• Type: IVD Reagent
• Accuracy: 99.2%
• Sensitivity: 98.1%
• Specimen: Sperm
• Format: Strips, Cassettes, Midstreams
• Certificate: CE0123
• Model NO.: SP-1013
• Specificity: 99.5%
• Transport Package: Carton
• Origin: Hangzhou
• HS Code: 3822190090
• Production Capacity: 3000000PCS/Day

Product Description

One Step Male Fertility Sperm Concentration Test For Home Use diagnostic test kits

The SP-10 Male Fertility Rapid Test is for in vitro qualitative detection of Acrosomal Protein SP-10 found on sperms to estimate of sperm concentration in human semen above or below 15 million/mL as an aid in male infertility diagnosis.

SP-10 Male Fertility Rapid Test Kit Parameters:
 

Produt name	One Step Male Fertility Sperm Concentration Test
Sensitivity	98.1%
Accuracy	98.2%
Cut-off	15 million/mL
Shelf time	24-36 month
OEM time	20 days
Certificate	CE/ISO13485/FDA
Specimen	Sperm
Format	Cassette
Reading time	within 5  minutes.

SP-10 Male Fertility Rapid Test Kit Contents:
 

Product name	Quantity(pcs)
Test Cassette	2
Semen transfer devices	2
Sample dilution buffer	2
Collection cups	2
Washing Solution	1
Package insert	1
Workstation	1

Picture Display:

 READING THE RESULTS

(Please refer to the illustration below)
NORMAL:* Two colored 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 SP- 10 protein present in the specimen. Therefore, any shade of color in the test line region (T) should be considered normal .

ABNORMAL: 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.
Note: If for any reason, the results are considered to be doubtful or inaccurate, the test should be repeated with another test unit. However, the subject must not ejaculate through any sexual activity for 6 days before carrying out the second test. If the second test is still abnormal,
discussed with doctor or medical professional .





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One Step Fertility & Eugenic Test Products Profile
 

Product	Specimen	Type	Sensitivity
Pregnancy HCG Test Kit	Urine/Serum	strip/cassette/midstream	25mIU/ml
Digital Pregnancy Test Kit	Urine	midstream	25mIU/ml
Ovulation (LH) Test Kit	Urine	strip/cassette/midstream	25mIU/ml
FSH(Follicle-stimulating Hormone)	Urine	strip/cassette/midstream	25mIU/ml
fFN(Fetal Fibronectin)	cervical mucus	strip/cassette	25ng/ml
Sperm-density	Semen	cassette	N/A
HSV I lgG/lgM	whole blood/ serum/plasma	cassette	N/A
HSV II lgG/lgM	whole blood/ serum/plasma	cassette	N/A
HSV 1+2 lgG/lgM	whole blood/ serum/plasma	cassette	N/A
TOXO IgG/IgM	whole blood/ serum/plasma	cassette	N/A
RV IgG/IgM	whole blood/ serum/plasma	cassette	N/A
CMV IgG/IgM	whole blood/ serum/plasma	cassette	N/A
TORCH IgM combo-5	whole blood/ serum/plasma	cassette	N/A
TORCH IgG/IgM combo-5	whole blood/ serum/plasma	cassette	N/A