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hCG Pregnancy Rapid Test

FDA approved and CE marked HCG Pregnancy test kits, highly sensitive for the confirmation of pregnancy in the very earlier stage.

HCG Midstream

Intended Use

CE0123 markNOVAtest ® one-step HCG Pregnancy rapid test kits are approved by US.FDA, and with CE0123 mark for self-testing. These kits are a highly sensitive testing kit for the detection of human chorionic gonadotrophin hormone (hCG) in urine or serum specimen, as a rapid test device to confirm pregnancy in the very earlier stage.

With hCG urine test, positive levels (higher than 10 mIU/ml) in the blood can be detected as early as 1 to 2 days after missing a period. The merits of HCG urine pregnancy test kits are: less expensive; can be done at home if only following the testing procedures shown in the instruction leaflet.

NOVAtest ® hCG rapid tests are easy to use and give a visual, qualitative result, and have been inspected by EU notified party TUV and can be sold to self-testing market, so our hCG pregnancy self-testing kit are suitable to be performed in the home with the confidentiality and privacy that one's house can offer.

hCG Concentration

the chart of HCG Concentration

The hCG level in non-pregnant females is less than 5.0 mIU/ml, which reaches 5-50 mIU/ml three weeks after the last menstrual period, and 2,000mIU/mL a month after conception. The rapid rise of hCG concentration after conception makes it an excellent marker for early confirmation of pregnancy. Following delivery, the hCG normally drops to non-pregnant level within two weeks. Ectopic pregnancies and pregnancies terminating in spontaneous abortion tend to have lower than normal circulating hCG levels, while somewhat higher levels are often seen in multiple pregnancies.

The function of hCG

Human chorionic gonadotropin (hCG) is initially secreted by the trophoblastic cells of the placenta shortly after implantation of the fertilized ovum into the uterine wall. This hormone is critical to the viability of the fetus, by preventing the disintegration of the corpus luteum of the ovary and thereby maintaining progesterone production that is critical for a pregnancy in humans; it also affects the immune tolerance of the pregnancy so as the fetus is not rejected by the maternal body.

 

Human Chorionic Gonadotropin (hCG) Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
HCG 112 HCG Urine Test Strip urine 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HCG 113 HCG Test Cassette 4.0 mm urine 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HCG 113N HCG Test Cassette 3.0 mm urine 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HCG 114 HCG Test Midstream urine 1 Bulk: 1200 PCS
Boxed: 400 Boxes
HCG 115 HCG Combo Test Strip urine/serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HCG 116 HCG Combo Test Cassette urine/serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
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HCG Pregnancy Urine test kit

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HCG Urine Test Strip

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HCG 112
Description:HCG Urine Test Strip
Category:Fetility & Eugenics
Style:Dipstick
Unit:PCS
Specimen:urine
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:2.5 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

Specimen

Urine Collection

A urine specimen must be collected in a clean and dry container.

For hormone test such as HCG prenancy test, the first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.

Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.

urine Storage Condition

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C.

Frozen specimens should be thawed and mixed before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

HCG Test Cassette 4.0 mm

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HCG 113
Description:HCG Test Cassette 4.0 mm
Category:Fetility & Eugenics
Style:Card
Unit:PCS
Specimen:urine
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.

Specimen

Urine Collection

A urine specimen must be collected in a clean and dry container.

For hormone test such as HCG prenancy test, the first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.

Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.

urine Storage Condition

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C.

Frozen specimens should be thawed and mixed before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

HCG Test Cassette 3.0 mm

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HCG 113N
Description:HCG Test Cassette 3.0 mm
Category:Fetility & Eugenics
Style:Card
Unit:PCS
Specimen:urine
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.

Specimen

Urine Collection

A urine specimen must be collected in a clean and dry container.

For hormone test such as HCG prenancy test, the first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.

Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.

urine Storage Condition

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C.

Frozen specimens should be thawed and mixed before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

HCG Test Midstream

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HCG 114
Description:HCG Test Midstream
Category:Fetility & Eugenics
Style:Midstream
Unit:PCS
Specimen:urine
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:6.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:1 Test
Box Dimension:18.5 * 6.0 * 1.5 CM
Kits per CTN:400 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • HCG Urine Test Midstream in single foil pouch;
  • Disposable Urine Cup (optional);
  • Instruction for use.

Specimen

Urine Collection

A urine specimen must be collected in a clean and dry container.

For hormone test such as HCG prenancy test, the first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.

Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.

urine Storage Condition

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C.

Frozen specimens should be thawed and mixed before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

HCG Combo Test Strip

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HCG 115
Description:HCG Combo Test Strip
Category:Fetility & Eugenics
Style:Dipstick
Unit:PCS
Specimen:urine/serum
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

Specimen

Urine Collection

A urine specimen must be collected in a clean and dry container.

The first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

urine/serum Storage Condition

The specimens should be tested as soon as possible after collection.

The serum specimens can be stored up to 3 days at 2-8°C. For longer time storage, the specimens should be frozen at -20°C.

Urine specimens may be stored at 2-8°C for up to 48 hours. For long-term storage, specimens may be frozen and stored below -20°C.

Don’t freeze and thaw the specimens repeatedly.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

HCG Combo Test Cassette

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HCG 116
Description:HCG Combo Test Cassette
Category:Fetility & Eugenics
Style:Card
Unit:PCS
Specimen:urine/serum
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.

Specimen

Urine Collection

A urine specimen must be collected in a clean and dry container.

The first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

urine/serum Storage Condition

The specimens should be tested as soon as possible after collection.

The serum specimens can be stored up to 3 days at 2-8°C. For longer time storage, the specimens should be frozen at -20°C.

Urine specimens may be stored at 2-8°C for up to 48 hours. For long-term storage, specimens may be frozen and stored below -20°C.

Don’t freeze and thaw the specimens repeatedly.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle