Saliva collection and lysis system for self-testing of novel coronavirus antigens

Abstract

The present invention relates to a saliva collection and lysis system suitable for self-testing of novel coronavirus antigens, including a saliva collection funnel, a test tube, a dripper and a lid; a two-way valve is fixedly provided at the bottom of the saliva collection funnel; the test tube includes an integrally connected hose part and a hard connector part, and the hose part is provided with saliva scale lines and diluent scale lines from top to bottom in sequence; the dripper includes a first shell, a second shell, a drainage shell and a break-off head integrally connected from bottom to top, and a fold is provided between the drainage shell and the break-off head; after the break-off head is broken, a drip hole is formed on the drainage shell, and the dripper and the two-way valve can be connected to the test tube respectively; the lid is detachably fixedly connected to the second shell on the dripper, and is used to encapsulate the break-off head on the dripper therein. This technical solution facilitates the quantitative collection of saliva in the user's mouth into a test tube, and the drip hole can easily drip the mixture of saliva and diluent into the test card, and the diluent can improve the sensitivity of the detection.

Description

Technical Field

[0001] The present invention relates to the technical field of novel coronavirus detection, and in particular to a saliva collection and lysis system suitable for novel coronavirus antigen self-testing. Background Art

[0002] At present, the novel coronavirus antigen test strips are used to detect novel coronavirus infection, usually with nasopharyngeal or oropharyngeal samples. These samples need to be collected by inserting the break point swab into the nasopharynx or oropharynx, and then rotating it in the nasopharynx or oropharynx for 4-5 weeks for sampling. The collection method is related to the safety of the collection and the amount of samples collected. The swab is easy to break at the break point when collecting, which is easy to cause harm to personal safety. If the collection method is incorrect, the amount of samples collected does not meet the requirements, which is easy to affect the test results. Therefore, the professional requirements of the sampling personnel are relatively high. After the sample is collected, the sample is diluted with a diluent. The quality of the diluent is also related to the sensitivity and specificity of the result detection.

[0003] Studies have found that the saliva of people infected with the new coronavirus contains a certain amount of the new coronavirus. In view of the safety and sample volume of sample collection, this study invented a saliva collection and lysis system suitable for self-testing of the new coronavirus antigen. Saliva samples can be collected and diluted and lysed according to requirements. It is simple and convenient, with enhanced sensitivity and specificity. It is suitable for testing a large number of people and self-testing at home during an epidemic outbreak. Summary of the invention

[0004] The technical problem to be solved by the present invention is to make up for the deficiencies of the prior art and provide a saliva collection and lysis system suitable for self-testing of new coronavirus antigens.

[0005] To solve the above technical problems, the technical solution of the present invention is:

[0006] A saliva collection and lysis system suitable for self-testing of novel coronavirus antigens, comprising a saliva collection funnel, a test tube, a dropper and a cover;

[0007] The saliva collection funnel is used to assist in collecting saliva from the human body's mouth; a two-way valve is fixedly provided at the bottom of the saliva collection funnel, the two-way valve includes a first interface, a second interface and a switch knob, the first interface of the two-way valve is connected to the inner cavity of the saliva collection funnel, and the second interface of the two-way valve is an internal thread interface T;

[0008] The test tube is used to hold diluent and saliva; the test tube includes a hose part and a hard connection head part which are connected in one piece; the hard connection head part is provided with an external thread interface S, and the external thread interface S matches the internal thread interface T of the two-way valve; the hose part is provided with saliva scale lines and diluent scale lines from top to bottom in sequence;

[0009] The dripper is used to drip a mixture of saliva and diluent into the novel coronavirus antigen colloidal gold test card; the dripper includes a first shell, a second shell, a drainage shell and a breaking head which are integrally connected from bottom to top, and a fold is provided between the drainage shell and the breaking head; after the breaking head is broken, a drip hole is formed on the drainage shell, and an internal thread interface D is provided on the first shell, and the internal thread interface D matches the external thread interface S of the test tube;

[0010] The cover is detachably fixedly connected to the second shell on the dripper and is used to encapsulate the drainage shell and the breaking head on the dripper therein.

[0011] Furthermore, it also includes a stirring rod, which is fixed on the first shell of the dripper. After the internal thread interface D of the dripper is screwed with the external thread interface S of the test tube, the stirring rod is located in the inner cavity of the test tube, and the bottom end of the stirring rod is below the dilution liquid scale line.

[0012] Furthermore, the stirring rod is provided with an external thread J, and the lower end of the external thread J starts from the lower end of the stirring rod; when the internal thread interface D of the dripper is screwed with the external thread interface S of the test tube, the upper end of the external thread J is located above the saliva scale line.

[0013] Furthermore, the stirring rod includes an integrally connected rod body and a connecting head, the connecting head is fixed on the first shell of the dripper, and a notch is provided on the connecting head. When the internal thread interface D of the dripper is screwed with the external thread interface S of the test tube, the inner cavity of the first shell of the dripper is connected with the inner cavity of the test tube through the notch on the connecting head.

[0014] Furthermore, it also includes a plurality of glass beads, which are used to be placed in the inner cavity of the test tube.

[0015] Furthermore, the diameter of the glass beads is 1 to 3 mm, and the number of the glass beads is 3 to 10.

[0016] Furthermore, the contact point between the saliva collecting funnel and the human face is provided with an arc-shaped incision that fits the human face.

[0017] Furthermore, the hose portion of the test tube is made of soft plastic, and the hard connection head is made of hard plastic.

[0018] A diluent for the saliva collection and lysis system suitable for self-testing of novel coronavirus antigens as described above, comprising the following components: 0.5% to 1.5% by mass of SDS, 3% to 5% by mass of trehalose, 0.05% to 0.1% by mass of tris(2-carbonylethyl)phosphine hydrochloride, and pH 7.8 to 8.5.

[0019] Furthermore, the invention comprises the following components: 0.5% to 1.5% by mass of SDS, 0.1% to 0.3% by mass of EDTA.2Na, 3% to 5% by mass of trehalose, 0.3% to 0.7% by mass of sodium lauryl sarcosinate, 0.3% to 0.7% by mass of Triton X-100, 0.05% to 0.1% by mass of tris(2-carbonylethyl)phosphine hydrochloride, 0.1% to 0.2% by mass of Tris, 0.5% to 1.5% by mass of NaCl, 0.1% to 0.2% by mass of HY-500, and pH 7.8 to 8.5.

[0020] The beneficial effects that can be achieved by the present invention are:

[0021] (1) It is convenient for users to collect saliva in their mouths through a saliva collection funnel into a test tube containing a diluent, and to control the dilution amount of the saliva;

[0022] (2) The user can easily add the mixture of saliva and diluent to the 2019-nCoV antigen colloidal gold test card through the drip hole that appears after the drip head is broken off.

[0023] (3) After the saliva and the diluent are evenly mixed, the lysis solution can more effectively remove impurities in the saliva, lyse the new coronavirus, fully expose the nucleocapsid protein (N protein) of the new coronavirus, and improve the sensitivity of the new coronavirus antigen colloidal gold method detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is an exploded view of embodiment 1 of the present invention;

[0025] Figure 2 is a stereoscopic diagram of the test tube in Example 1 of the present invention;

[0026] Figure 3 is a stereoscopic diagram of the dripper in Example 1 of the present invention;

[0027] Figure 4 is a three-dimensional diagram of a stirring rod in Example 1 of the present invention;

[0028] Figure 5 is a schematic diagram of the combination of the stirring rod and the dripper in Example 1 of the present invention;

[0029] Figure 6 This is a schematic diagram of the combination of the test tube, the dripper, the cover, the stirring rod, and the glass beads in Example 1 of the present invention;

[0030] Figure 7 Schematic diagram of the drip hole after the breaking head is broken in Example 1 of the present invention;

[0031] Figure 8is a front view of the saliva collection funnel in Example 1 of the present invention;

[0032] Fig. 9 is a schematic diagram of the use steps of Example 1 of the present invention;

[0033] Fig.10 This is the test sensitivity comparison result I of Example 2 of the present invention and the existing diluent products on the market;

[0034] Fig.11 This is the test sensitivity comparison result II of Example 2 of the present invention and the existing diluent products on the market;

[0035] Fig.12 The test sensitivity comparison result of Example 2 of the present invention and the existing diluent products on the market is III;

[0036] In the figure: 1-test tube, 101-hose part, 102-hard connector part, 103-saliva scale line, 104-dilution scale line; 2-drip tip, 201-first shell, 202-second shell, 203-drainage shell, 204-break head, 205-drip hole; 3-lid, 4-stirring rod, 401-rod body, 402-connector, 403-notch, 404-external thread J; 5-glass beads, 6-saliva collection funnel, 601-arc-shaped incision; 7-two-way valve. DETAILED DESCRIPTION

[0037] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0038] Example 1

[0039] like Figure 1 As shown, a saliva collection and lysis system suitable for self-testing of novel coronavirus antigens includes a saliva collection funnel 6, a test tube 1, a dripper 2, a cover 4 and a plurality of glass beads 5;

[0040] The saliva collecting funnel 6 is used to assist in collecting saliva from the human mouth. The cross section of the funnel portion of the saliva collecting funnel 6 can be circular, elliptical, square, or other shapes. For ease of storage, the cross section of the funnel portion is selected to be elliptical in this embodiment. In addition, in order to make the upper opening of the funnel portion better fit the human face, according to the ergonomic design, an arc-shaped incision 601 that fits the human face is provided at the contact point between the saliva collecting funnel 6 and the human face, such as Figure 8 As shown, it is also convenient to scrape off the saliva that is stuck below the lips; a two-way valve 7 is fixedly provided at the bottom of the saliva collecting funnel 6, and the two-way valve 7 includes a first interface, a second interface and a switch knob. The first interface of the two-way valve 7 is connected to the inner cavity of the saliva collecting funnel 6, and the second interface of the two-way valve 7 is an internal threaded interface T.

[0041] Test tube 1 is used to hold diluent and saliva; Figure 2 As shown, the test tube 1 includes an integrally connected hose portion 101 and a hard connection head portion 102, the hard connection head portion 102 is provided with an external thread interface S, and the external thread interface S matches the internal thread interface T of the two-way valve 7; the hose portion 101 is provided with saliva scale lines 103 and diluent scale lines 104 from top to bottom; the hose portion 101 is made of soft plastic, which is easy to knead; the hard connection head portion 102 is made of hard plastic, and the threaded connection does not deform.

[0042] The dripper 2 is used to drip the mixture of saliva and diluent into the novel coronavirus antigen colloidal gold test card; Figure 3 As shown, the dripper 2 includes a first shell 201, a second shell 202, a drainage shell 203 and a break-off head 204 which are integrally connected from bottom to top, and a fold is provided between the drainage shell 203 and the break-off head 204; after the break-off head 204 is broken, a drip hole 205 is formed on the drainage shell 203, as shown in FIG. Figure 7 As shown, an internal thread interface D is provided on the first housing 201 , and the internal thread interface D matches the external thread interface S of the test tube 1 .

[0043] The stirring rod 4 is fixed to the first housing 201 of the dripper 2. After the internal thread interface D of the dripper 2 is screwed to the external thread interface S of the test tube 1, the stirring rod 4 is located in the inner cavity of the test tube 1, and the bottom end of the stirring rod 4 is below the dilution scale line 104, as shown in FIG. Figure 6 As shown;

[0044] like Figure 4 As shown, the stirring rod 4 includes a rod body 401 and a connector 402 that are integrally connected. The connector 402 is fixed to the first shell 201 of the dripper 2. A notch 403 is provided on the connector 402. When the internal thread interface D of the dripper 2 is screwed to the external thread interface S of the test tube 1, the inner cavity of the first shell 201 of the dripper 2 is connected to the inner cavity of the test tube 1 through the notch 403 on the connector 402. Figure 5 As shown;

[0045] In order to better mix the saliva and the diluent, an external thread J is provided on the stirring rod 4. Figure 4 As shown, the lower end of the external thread J starts from the lower end of the stirring rod 4; after the internal thread interface D of the dripper 2 is screwed to the external thread interface S of the test tube 1, the upper end of the external thread J is located above the saliva scale line 103.

[0046] In order to further mix the saliva and the diluent evenly, a number of glass beads 5 are provided. In this embodiment, 10 glass beads 5 with a diameter of 1 mm are placed in the inner cavity of the test tube 1. Figure 6 shown.

[0047] The cover 4 is detachably fixedly connected to the second housing 202 on the dripper 2 via threads, and is used to encapsulate the drainage housing 203 and the breaking head 204 on the dripper 2 therein.

[0048] The steps of using this embodiment are as follows: Fig. 9 As shown:

[0049] The initial state of use is: add diluent to the test tube 1 to the diluent scale line 104, add glass beads 5 to the test tube 1, connect the dripper 2 fixedly connected with the stirring rod 4 to the test tube 1, and set aside; the use steps are as follows:

[0050] (1) Separate the test tube 1 containing the diluent from the dripper 2.

[0051] (2) Set the state of the two-way valve 7 below the saliva collection funnel 6 to "off".

[0052] (3) The saliva collecting funnel 6 is connected to the test tube 1 through the internal thread interface T at the bottom of the two-way valve 7, and the user spits saliva into the saliva collecting funnel 6; the switch knob of the two-way valve 7 is opened appropriately to control the saliva to enter the test tube 1, and when the amount of saliva added reaches the saliva scale line 103, the switch knob of the two-way valve 7 is closed; then the two-way valve is unscrewed from the test tube 1 to disconnect the internal thread interface T at the bottom of the two-way valve 7 from the test tube 1, and the combination of the saliva collecting funnel 6 and the two-way valve 7 is removed.

[0053] (4) The mixture of saliva and diluent in the test tube 1 is stirred by the stirring rod 4, and the two are evenly mixed under the joint action of the stirring rod 4 and the glass beads 5; then the dripper 2 fixedly connected with the stirring rod 4 is connected to the test tube 1.

[0054] (5) Break off the break-off head 204 on the dripper 2 to form a drip hole 205 on the drainage shell 203; tilt the test tube 1 downward, squeeze the hose part 101 of the test tube 1 to allow the mixture of saliva and diluent to drip through the drip hole 205 into the SARS-CoV-2 antigen colloidal gold test card for testing, and interpret the results within 15-20 minutes.

[0055] (6) After the dripping is completed, the cover 4 is screwed onto the second shell 202 on the dripper 2 so that the cover 4 encloses the drip hole 205 therein.

[0056] Advantages of this embodiment:

[0057] (1) It is convenient for users to collect saliva in their mouths through a saliva collection funnel into a test tube containing a diluent, and to control the dilution amount of the saliva;

[0058] (2) After saliva collection is completed, the saliva and diluent can be more effectively mixed with the glass beads and stirring rod;

[0059] (3) The user can easily add the mixture of saliva and diluent to the 2019-nCoV antigen colloidal gold test card through the drop hole.

[0060] Example 2

[0061] A diluent for use in Example 1, comprising the following components: 1% by mass of SDS, 0.2% by mass of EDTA.2Na, 5% by mass of trehalose, 0.5% by mass of sodium lauryl sarcosinate, 0.5% by mass of Triton X-100, 0.07% by mass of tris(2-carbonylethyl)phosphine hydrochloride (TCEP), 0.12% by mass of Tris, 0.8% by mass of NaCl, and 0.1% by mass of HY-500, and the pH is adjusted to 8.2.

[0062] SDS can effectively lyse the new coronavirus, trehalose and tri(2-carbonylethyl)phosphine hydrochloride (TCEP) can effectively protect the new coronavirus antigen, sodium lauryl sarcosine, Triton X-100, and EDTA.2Na can effectively remove impurities in saliva, Tris is a buffer component, and HY-500 is a preservative to prevent bacterial growth.

[0063] Advantages of this embodiment: After the saliva and the diluent are evenly mixed, the lysis solution can more effectively remove impurities in the saliva, lyse the new coronavirus, and fully expose the nucleocapsid protein (N protein) of the new coronavirus; improve the sensitivity of the new coronavirus antigen colloidal gold method detection.

[0064] The test sensitivity comparison results of this embodiment and the existing diluent products on the market are as follows: Figure 10-12 As shown in the figure, the mark (1) is the test result of this embodiment, and the marks (2) and (3) are the test results of diluent products currently available on the market from two different manufacturers.

[0065] from Figure 10-12 It can be clearly seen that the test result of mark (1) is clearer, which means that the diluent in this embodiment has a higher detection sensitivity in the novel coronavirus antigen colloidal gold method.

[0066] In the description of the present invention, words indicating orientation or positional relationship such as "inside", "outside", "upper", "lower", "front", and "back" are only used to facilitate the description of the present invention, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0067] The above is only one embodiment of the present invention. The protection scope of the present invention is not limited to the above embodiment. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications made without departing from the idea of ​​the present invention are all within the protection scope of the present invention.

Claims

1. A saliva collection and lysis system suitable for self-testing of novel coronavirus antigens, characterized by: It includes a saliva collection funnel (6), a test tube (1), a dripper (2) and a cover (3); The saliva collection funnel (6) is used to assist in collecting saliva from the human body's mouth; a two-way valve (7) is fixedly provided at the bottom of the saliva collection funnel (6); the two-way valve (7) comprises a first interface, a second interface and a switch knob; the first interface of the two-way valve (7) is in communication with the inner cavity of the saliva collection funnel (6); and the second interface of the two-way valve (7) is an internal thread interface T; The test tube (1) is used to contain diluent and saliva; the test tube (1) comprises a hose portion (101) and a hard connection head portion (102) which are integrally connected; the hard connection head portion (102) is provided with an external threaded interface S, and the external threaded interface S matches the internal threaded interface T of the two-way valve (7); the hose portion (101) is provided with saliva scale lines (103) and diluent scale lines (104) in order from top to bottom; The dripper (2) is used to drip a mixture of saliva and a diluent into a novel coronavirus antigen colloidal gold test card; the dripper (2) comprises a first shell (201), a second shell (202), a drainage shell (203) and a break-off head (204) which are integrally connected from bottom to top, and a fold is provided between the drainage shell (203) and the break-off head (204); after the break-off head (204) is broken, a drip hole (205) is formed on the drainage shell (203), and an internal thread interface D is provided on the first shell (201), and the internal thread interface D matches the external thread interface S of the test tube (1); The cover (3) is detachably fixedly connected to the second housing (202) on the dripper (2), and is used to encapsulate the drainage housing (203) and the breaking head (204) on the dripper (2) therein; It also comprises a stirring rod (4), which is fixed on the first shell (201) of the dripper (2); when the internal thread interface D of the dripper (2) is screwed to the external thread interface S of the test tube (1), the stirring rod (4) is located in the inner cavity of the test tube (1), and the bottom end of the stirring rod (4) is below the dilution scale line (104); It also includes a plurality of glass beads (5), which are used to be placed in the inner cavity of the test tube (1); the diameter of the glass beads (5) is 1 to 3 mm, and the number is 3 to 10; The diluent comprises the following components: SDS in an amount of 0.5% to 1.5% by mass, EDTA·2Na in an amount of 0.1% to 0.3% by mass, trehalose in an amount of 3% to 5% by mass, sodium lauryl sarcosinate in an amount of 0.3% to 0.7% by mass, Triton X-100 in an amount of 0.3% to 0.7% by mass, tris(2-carbonylethyl)phosphine hydrochloride in an amount of 0.05% to 0.1% by mass, Tris in an amount of 0.1% to 0.2% by mass, NaCl in an amount of 0.5% to 1.5% by mass, HY-500 in an amount of 0.1% to 0.2% by mass, and pH 7.8 to 8.5; The initial state of use is: add diluent to the test tube (1) to the diluent scale line (104), add glass beads (5) to the test tube (1), connect the dripper (2) fixedly connected with the stirring rod (4) to the test tube (1) and set aside; the use steps are as follows: S1: Separate the test tube (1) containing the diluent from the dripper (2); S2: setting the state of the two-way valve (7) below the saliva collection funnel (6) to "off"; S3: The saliva collection funnel (6) is connected to the test tube (1) via the internal threaded interface T at the bottom of the two-way valve (7), and the user spits saliva into the saliva collection funnel (6); the switch knob of the two-way valve (7) is opened appropriately to control the saliva to enter the test tube (1); when the amount of saliva added reaches the saliva scale line (103), the switch knob of the two-way valve (7) is closed; the two-way valve (7) is then unscrewed from the test tube (1), so that the internal threaded interface T at the bottom of the two-way valve (7) is disconnected from the test tube (1), and the combination of the saliva collection funnel (6) and the two-way valve (7) is removed; S4: stirring the mixture of saliva and diluent in the test tube (1) by means of a stirring rod (4), and mixing the two uniformly under the combined action of the stirring rod (4) and the glass beads (5); and then connecting the dripper (2) fixedly connected to the stirring rod (4) to the test tube (1); S5: breaking off the breaking head (204) on the dripper (2) to form a drip hole (205) on the drainage shell (203); tilting the test tube (1) downward, squeezing the hose portion (101) of the test tube (1) to allow the mixture of saliva and the diluent to drip through the drip hole (205) into the novel coronavirus antigen colloidal gold test card for testing, and interpreting the result within 15-20 minutes; S6: After the dripping is completed, the cover (3) is screwed onto the second shell (202) on the dripper (2), so that the cover (3) encloses the dripping hole (205) therein.

2. The saliva collection and lysis system suitable for self-testing of novel coronavirus antigens according to claim 1 is characterized in that: The stirring rod (4) is provided with an external thread J, the lower end of the external thread J starting from the lower end of the stirring rod (4); when the internal thread interface D of the dripper (2) is screwed to the external thread interface S of the test tube (1), the upper end of the external thread J is located above the saliva scale line (103).

3. The saliva collection and lysis system suitable for self-testing of novel coronavirus antigens according to claim 1 is characterized in that: The stirring rod (4) comprises a rod body (401) and a connecting head (402) which are integrally connected. The connecting head (402) is fixed to the first shell (201) of the dripper (2). A notch (403) is provided on the connecting head (402). When the internal thread interface D of the dripper (2) is screwed to the external thread interface S of the test tube (1), the inner cavity of the first shell (201) of the dripper (2) is connected to the inner cavity of the test tube (1) through the notch (403) on the connecting head (402).

4. The saliva collection and lysis system suitable for self-testing of novel coronavirus antigens according to claim 1 is characterized in that: The saliva collection funnel (6) is provided with an arc-shaped incision (601) which fits the human face at the point where it contacts the human face.

5. The saliva collection and lysis system suitable for self-testing of novel coronavirus antigens according to claim 1 is characterized in that: The hose portion (101) of the test tube (1) is made of soft plastic, and the hard connector portion (102) is made of hard plastic.

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