The Saliva Pregnancy Test Kit is a rapid chromatographic immunoassay for the qualitative detection of HCG in saliva to aid in the early detection of pregnancy.

HCG is a glycoprotein produced by the placenta during pregnancy, which can enter the whole body through the blood circulation of pregnant women. Saliva is known to be very similar to its blood components, so it can be used as a test of HCG. The content of HCG changes with the growth of the embryo. In normal pregnancy, HCG can be detected in saliva after 7 to 10days after conception, whch can assis in the diagnosis ofearly pregnancy.

The test strip uses a double antibody sandwich immunochromatographic method and consists of a nitrocellulose membrane coated with anti-α-HCG monoclonal antibody and anti-mouse IgG polyclonal antibody, and a latex microsphere binding pad labeled with anti-β-HCG monoclonal antibody, as wellas other reagents. The LoD of this product is 5mlU/mL.

For detection, an appropriate amount of treated saliva samples is dropped into the sample well and chromatographed upward under capillary effect. If positive the HCG in the specimen first binds to the latex mcrosphere-labeled HCG antibody during the chromatography process to form the HCG-antibody-latex microsphere complex. Then, the complex will continue to chromatograph and bind to the a HCG antibody fixed on the membrane resulting in a red band appearing in the detection line area (T). If negative, there will be no red band in the test line area (T). With or without HCG in the sample, a red band should appear in the quality control area (C) to prove the validity of the test results.

FAQs

	What is the Bioteke Saliva Pregnancy Test Kit and how does it work?
	The Bioteke Saliva Pregnancy Test Kit is a lateral flow immunochromatographic rapid test that detects the HCG in human saliva. The user collects a small saliva sample using a collector and diluent tube, applies it to the test cassette, and reads results in 5-10 minutes. Two visible lines indicate a positive (pregnant) result; one line indicates negative.

	Is a saliva pregnancy test as accurate as a urine test?
	The Bioteke Saliva Pregnancy Test achieves ≥99% clinical accuracy compared to urine-based reference methods in controlled clinical studies.

What regulatory certifications does this product hold?

The Bioteke Saliva Pregnancy Test Kit holds CE marking under the EU IVD Directive (98/79/EC) & EU 2017/746 (IVDR), is manufactured under an ISO 13485:2016-certified quality management system. The product technical file, Declaration of Conformity, and clinical evaluation report are available to B2B buyers upon request for regulatory affairs and market access teams in the EU, UK, Southeast Asia, Middle East, and other regulated markets.

Does this test require refrigeration during shipping or storage?

No refrigeration is required. The test is stable at 2°C–30°C for 24 months from manufacture date when stored in the original sealed foil pouch. This ambient temperature stability makes the Bioteke Saliva Pregnancy Test Kit suitable for sea freight, air freight, and last-mile distribution in tropical climates without cold-chain infrastructure. Cartons should be kept away from direct sunlight, high humidity, and temperatures above 30°C.

	How is the saliva sample collected and applied to the test?
	The user stimulates saliva production naturally, keep your mouth clean for at least 30 minutes. Insert the saliva collector into the diluent tube. Spit saliva into a saliva collector. Screw the diluent tube cap, upside down mixing for 10 seconds. Squeeze 3 drops onto the sample well of the test card.

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Our sales team responds within 8 hours. Samples, pricing, and regulatory documents available on request.

E-mail

zr@bioteke.cn

Whatsapp/Phone/Wechat

+8613357927939

Download

• saliva pregnancy test brochure V0.pdf

• IFU-ICA2235.pdf