KR20230139802A - Specimen Validation Line and Immunodiagnostic Kit Comprising the Same - Google Patents

Abstract

The present invention relates to a sample validity confirmation line and an immunodiagnostic kit including the same, which can control false negative reactions for diagnostic samples of a target disease by determining whether standard substances present in the diagnostic sample are detected at the diagnostic sample collection stage. It works.

Description

Specimen Validation Line and Immunodiagnostic Kit Comprising the Same}

The present invention relates to a sample effectiveness confirmation line for controlling false negative reactions to a diagnostic sample of a target disease by determining whether a standard substance present in the diagnostic sample is detected at the diagnostic sample collection stage and an immunodiagnostic kit including the same.

Antigen testing is a testing method that detects the presence or absence of virus-specific antigens in a patient sample. An antibody that specifically binds to a specific antigen, such as the capsid or envelope protein of the virus, is used as a detection reagent. Detection methods that use this antigen-antibody reaction include enzyme-linked immunosorbent assay, chemiluminescence immunoassay, and immunochromatography, and lateral flow immunoassay, a type of immunochromatography, is a disposable device. It has been developed and is widely used in self-diagnosis kits because of its advantages of not losing reagents even when testing one sample at a time, and of being able to obtain results within 15 to 30 minutes through simple operation without special equipment.

The principles of immunochromatography are as follows. The test line of the device is coated with a primary antibody that can bind to the target antigen, so if there is a target antigen in the diagnostic sample, the antigen is captured by the antibody on the test line through an antigen-antibody reaction. If a secondary antibody bound to colloidal gold or a fluorescent substance reacts with this and the test line appears as a band, it is read as positive.

However, since the antigen test does not have a process to amplify the target antigen like the nucleic acid amplification method, detection requires the presence of a large amount of virus in the patient's sample, and therefore has a problem of lower sensitivity compared to genetic tests such as the nucleic acid amplification method. In addition, the nucleic acid amplification method uses internal control (IC) technology to confirm test abnormalities or abnormalities in the collected samples. When using an immunodiagnostic kit for self-diagnosis, which is an antigen test, this technology is not applied, so if the sample is not properly collected and only the diagnostic sample is deployed in the immunodiagnostic kit, the result may be negative. In this case, the person who performed the test is read as negative even though there is no target antigen in the diagnostic sample. Additionally, individuals who are not fully familiar with the product's instructions may not be able to collect a sufficient amount of target antigen during the diagnostic sample collection stage to proceed with the test. In this case, a person infected with the pathogen may be read as a false negative. As shown in Figure 2, in the case of immunodiagnostic kits developed to date, Rabbit IgG, Chicken IgY, Anti-Rabbit IgG, Anti-Chicken IgY, etc. are used even when a control line (50) is present, allowing for sample collection. It is impossible to verify the validity of . As an example case, for quarantine purposes in a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; hereinafter referred to as 'COVID-19 virus') pandemic, based on the results of a self-diagnosis kit test There was a case where access to the building was controlled, but an infected patient placed only the diagnostic sample in an immune diagnostic kit and disguised it as a negative in order to hide the fact of infection. Accordingly, there is a demand for an immunodiagnostic kit that can confirm the effectiveness of sample collection at the diagnostic sample collection stage.

Republic of Korea registered patent 10-0735080

The purpose of the present invention is to provide a confirmation line that can confirm the effectiveness of sample collection at the diagnostic sample collection stage.

Another object of the present invention is to provide an immunodiagnostic kit equipped with the sample collection effectiveness confirmation line.

The purpose of the present invention is to describe the internal control technology used in nucleic acid amplification method and provide a confirmation line that can confirm the effectiveness of sample collection so that it can be applied to immunodiagnostic kits.

As a means to increase sensitivity by universalizing self-diagnosis kits, the purpose is to provide a confirmation line to confirm the effectiveness of sample collection with the goal of personal quarantine and early diagnosis.

In order to achieve the above object, the present invention provides a confirmation line that can confirm the effectiveness of sample collection in the diagnostic sample collection step. More specifically, false negative reactions for diagnostic samples of the target disease can be controlled by determining whether standard substances such as Human IgM present in the diagnostic sample are detected.

Additionally, the present invention provides an immunodiagnostic kit equipped with the sample validity confirmation line.

The present invention provides a method for confirming the effectiveness of sample collection using the above immunodiagnostic kit.

The present invention has the effect of confirming the effectiveness of sample collection by determining whether or not standard substances present in the diagnostic sample are detected at the diagnostic sample collection stage.

In addition, the present invention has the effect of improving the reliability of the immunodiagnostic kit by controlling false negative reactions to diagnostic samples of the target disease.

Figure 1 is a diagram showing an immune diagnostic kit according to an embodiment of the present invention.
Figure 2 is a diagram showing an immunodiagnostic kit according to the prior art, which does not have a means for confirming standard substances.
Figure 3 shows an immunodiagnostic kit including a sample validity confirmation line that can confirm the standard substance of the present invention. More specifically, when a sample is effectively collected, the effectiveness of sample collection is confirmed through the sample validity confirmation line of the present invention. This diagram shows the confirmation process.
Figure 4 shows an immunodiagnostic kit including a sample validity confirmation line that can confirm the standard substance of the present invention. More specifically, if the sample is not collected effectively, the effectiveness of sample collection is checked through the sample validity confirmation line of the present invention. This diagram shows the process of checking.
Figure 5 shows a comparison between the control line of a conventional immunodiagnostic kit and the sample validity confirmation line of the immunodiagnostic kit of the present invention. Unlike the prior art, the sample effectiveness confirmation line of the present invention has a means for confirming a standard substance. This diagram shows that the effectiveness of sample collection can be confirmed.
Figure 6 shows that, using the immunodiagnostic kit of the present invention, samples were collected from 9 people according to the standard sample collection method, and when samples were collected without following the standard sample collection method, each was tested and the sample collection was performed. This diagram shows the results of confirming effectiveness.

The present invention relates to a sample effectiveness confirmation line and an immunodiagnostic kit including the same, which confirms the effectiveness of sample collection by determining whether standard substances such as human IgM present in the diagnostic sample are detected at the diagnostic sample collection stage, thereby performing immunodiagnosis. It has the effect of improving the reliability of the kit.

Hereinafter, the present invention will be described in more detail.

<Sample validity confirmation line>

The sample effectiveness confirmation line of the present invention is a line that can confirm the effectiveness of sample collection by detecting standard substances present in the diagnostic sample,

Specifically, the standard substance present in the diagnostic sample reacts specifically with the anti-standard substance antibody immobilized on the sample validity confirmation line to produce a band.

standard material

The standard substance may be a substance inherently included in the diagnostic sample.

The diagnostic sample may be bodily fluid or secretion from a human or non-human animal. For example, it includes blood, serum, plasma, lymph, tissue fluid, urine, tears, saliva, milk, vomit, and feces, and may be a sample passed through the respiratory tract such as exhaled breath, and preferably may be human blood.

Additionally, the diagnostic sample can be used by itself or diluted in a developing solution. In the present invention, 'diagnostic sample' refers to both those diluted in the developing solution and those that are not diluted. The developing solution is not particularly limited and any known in the art can be used, but preferably a buffer solution of pH 7 to 8 can be used, such as phosphate buffer solution (PBS) of pH 7.4, 0.5% TW-20, 50mM. A solution containing KCl, 300mM NaCl, and 0.1% NaN3 can be used.

Specifically, the standard materials may be secreted antibodies and housekeeping proteins, such as IgG, IgA, IgE, IgM, albumin, transferrin, GAPDH (glyceraldehyde 3-phosphate dehydrogenase), beta -It may be actin, alpha-tubulin, etc., and preferably may be IgG, IgA, IgM, albumin, and transferrin.

In particular, in the present invention, the standard material may be IgM, which is suitable for confirming the effectiveness of sample collection. Specifically, even though the concentration of human IgM in diagnostic samples such as runny nose is lower than that of human IgG, it shows a clearly superior confirmation effect in specimen validation experiments.

Anti-standard antibody

The anti-standard antibody binds specifically to the standard material and may be coated on the sample validity confirmation line.

The anti-standard antibodies include, for example, anti-human IgG antibodies, anti-human IgA antibodies, anti-human IgE antibodies, anti-human IgM antibodies, anti-human albumin antibodies, anti-human transferrin antibodies, anti-human GAPDH antibodies, It may be an anti-beta-actin antibody, an anti-alpha-tubulin antibody, etc., preferably an anti-human IgG antibody, an anti-human IgA antibody, an anti-human albumin antibody and an anti-human transferrin antibody, but are not limited thereto. No.

Sample validity confirmation line

The sample validity confirmation line of the present invention is characterized by including a means for confirming a standard substance, and can be located on the analysis strip 30 of the kit, preferably in a form having a width on the short side and a length on the long side. It may be, but is not limited to this.

The above-described anti-standard antibody is fixed to the sample validity confirmation line, and as described above, in the present invention, the standard material is a substance inherently included in the diagnostic sample, so the anti-standard material of the sample effectiveness confirmation line As the antibody detects the standard substance in the sample, it can be confirmed whether the diagnostic sample was collected effectively.

Specifically, according to one example of the present invention, the sample validity confirmation line of the present invention is present on an analysis strip, and more specifically, includes a sample pad for absorbing a diagnostic sample; Gold pad containing label-attached antibody; analysis strip; and an absorption pad that absorbs the diagnostic sample developing solution may be present in a kit that is overlapped and combined.

Figure 5 shows a comparison between the control line of a conventional immunodiagnostic kit and the sample validity confirmation line of the immunodiagnostic kit of the present invention. Unlike the prior art, the sample effectiveness confirmation line of the present invention has a means for confirming a standard substance. This diagram shows that the effectiveness of sample collection can be confirmed. Specifically, referring to Figure 5, (a) the control line 50 of the conventional immunodiagnostic kit includes a control line confirmation antibody 521, which merely detects the label-attached control line confirmation antibody, and thus is used as a diagnostic sample. It is impossible to confirm the validity of . In contrast, (b) the sample effectiveness confirmation line 51 of the present invention includes an anti-standard material antibody 511 and can detect the standard material in the diagnostic sample.

Figure 3 shows an immunodiagnostic kit including a sample validity confirmation line that can confirm the standard substance of the present invention. More specifically, when a sample is effectively collected, the effectiveness of sample collection is confirmed through the sample validity confirmation line of the present invention. This diagram shows the confirmation process.

Figure 4 shows an immunodiagnostic kit including a sample validity confirmation line that can confirm the standard substance of the present invention. More specifically, if the sample is not collected effectively, the effectiveness of sample collection is checked through the sample validity confirmation line of the present invention. This diagram shows the process of checking.

Referring to Figures 3 and 4, the immunodiagnostic kit of the present invention includes a label-attached anti-standard antibody (212) on the gold pad (21) or an anti-standard antibody (212) on the specimen validation line (51). It is also possible to detect standard substances in diagnostic samples, including the standard antibody 511.

As a more specific example, referring to FIGS. 3 and 4, when 3 to 4 drops of the diagnostic sample 10 in FIGS. 3A and 4A are dropped onto the sample pad 20, the diagnostic sample 10 is applied to the sample pad (20). It is absorbed through 20) and capillary action begins. Thereafter, in FIGS. 3B and 4B, the diagnostic sample 10 is labeled with a label-attached disease detection antibody (211; e.g., Black Gold COVID19 antibody conjugate) and a label-attached anti-standard antibody (212; e.g., Red Gold + Anti-Human IgM antibody conjugate) is moved to the fixed gold pad (21).

At this time, as shown in Figure 3b, when both the disease marker (e.g., COVID19 antigen) and the standard material (e.g., Human IgM) in the diagnostic sample 10 are present, they are each labeled-attached disease detection antibody ( 211) and a labeled anti-standard antibody (212). In FIG. 3C, when the diagnostic sample containing each of the combined conjugates flows to the test line 40 and the sample validity confirmation line 51 in the immunodiagnostic kit, if there is a disease marker in the diagnostic sample 10, A black band is observed on the test line 40, and when the diagnostic sample 10 is effectively collected and contains a standard material, a red band is detected by the anti-standard material antibody 511 on the sample validity confirmation line 51. A band on the back is observed. Additionally, label-attached antibodies flowing through the diagnostic sample accumulate on the absorbent pad 60.

Or, as an example, as shown in Figure 4b, when there is no disease marker (eg, COVID19 antigen) and standard material (eg, Human IgM) in the diagnostic sample 10, the label-attached disease detection antibody (211) ) and the label-attached anti-standard antibody (212) does not bind, and as shown in Figure 4c, the diagnostic sample (10) that does not contain the conjugate is shown in the test line (40) and the sample validity confirmation line ( When it flows to 51), a red band is not observed not only in the inspection line 40 but also in the sample validity confirmation line 51.

The sample effectiveness confirmation line of the present invention can appropriately select and apply conventional immune response principles depending on the diagnostic sample.

For example, when applying sandwich lateral flow immunochromatography (Sandwich Lateral Flow Immunochromatography Assay) to the sample validity confirmation line, (if the diagnostic sample is blood or serum), dropping an appropriate amount of diagnostic sample on the sample pad (a in Figure 3) ), the standard substance present in the diagnostic sample binds to the label-attached disease detection antibody 212 and is spread on a sample pad such as a nitrocellulose membrane by capillary action (Figure 3b). The label-attached disease detection antibody and antigen complex (212a) continues to unfold and combines with the anti-standard antibody immobilized on the specimen validation line (51) to form a sandwich complex (212b; Figure 3) c). Positiveness is diagnosed by visually checking the band indicated by the label of the antigen-antibody complex fixed on the specimen validation line (51). The unreacted contents seep into the absorbent pad, and the membrane of the inspection window appears clear white, making it easy to read the formed band.

(When the diagnostic sample is collected through the respiratory tract) When the collected diagnostic sample is dropped onto the sample pad (a in Figure 3), the standard substance present in the diagnostic sample binds to the label-attached disease detection antibody 212 and forms a capillary. By development, it is spread on a sample pad such as a nitrocellulose membrane (Figure 3b). The label-attached disease detection antibody and antigen complex (212a) continues to unfold and combines with the anti-standard antibody immobilized on the specimen validation line (51) to form a sandwich complex (212b; Figure 3) c). Positiveness is diagnosed by visually checking the band indicated by the label of the antigen-antibody complex fixed on the specimen validation line 51. The unreacted contents seep into the absorbent pad, and the membrane of the inspection window appears clear white, making it easy to read the formed band.

In contrast, Figure 2 is a diagram showing an immunodiagnostic kit according to the prior art, which does not have a means for confirming standard substances. Referring to FIG. 2, the conventional immunodiagnostic kit does not include a label-attached anti-standard antibody 212 on the gold pad 21, and therefore cannot detect the standard substance in the sample. In addition, the control line 50 does not include the anti-standard antibody 511, so the standard in the sample cannot be detected.

<Immune diagnostic kit>

The immunodiagnostic kit of the present invention is intended to confirm the effectiveness of sample collection by detecting a standard substance in a diagnostic sample, and is not particularly limited as long as it includes the sample validity confirmation line described above. Specifically, in the immunodiagnostic kit of the present invention, the standard substance in the diagnostic sample combines with the labeled anti-standard antibody of the gold pad to form a conjugate, and the anti-standard antibody of the specimen validity confirmation line forms the conjugate. It may be for detection.

Additionally, the disease to be diagnosed by the immunodiagnostic kit of the present invention is not particularly limited, but may be the COVID-19 virus.

More specifically, the immunodiagnostic kit of the present invention includes a sample pad (20), a gold pad (21), an analysis strip (30), and an absorption pad (60), and the analysis strip has a test line (40) and a sample effectiveness test kit. It may include a confirmation line 51. In particular, the sample validity confirmation line may be the sample validity confirmation line described above. Additionally, the sample validity confirmation line may be comprised of a control line and a sample validity confirmation line as one piece, or the analysis strip may further include a separate control line.

The sample pad 20, gold pad 21, analysis strip 30, and/or absorbent pad 60 of the present invention can be made of materials used in conventional diagnostic kits, for example, nitrocellulose, It may be one type selected from various synthetic polymers such as cellulose, cellulose acetate, and polyethylene.

An immunodiagnostic kit according to an embodiment of the present invention is shown in Figures 1, 3, and 4. According to the drawing, the immunodiagnostic kit of the present invention includes a sample pad 20, a gold pad 21, an analysis strip 30, and an absorption pad 60, and a test line 40 is placed on the analysis strip 30. ) In addition, the sample validity confirmation line (51) and control line (50) are located on the same line. The present invention is not limited to this, and includes a test line 40, a sample validity confirmation line 51, and a control line 50 located on different lines on the analysis strip 30, and also includes other forms.

The sample pad 20 is a part that absorbs a diagnostic sample, and sample pads from conventionally known kits can be applied without limitation.

The gold pad 21 is also referred to as a gold conjugation pad, and is located adjacent to the sample pad 20, and may be configured to be bonded to a portion of the sample pad as shown in FIG. 1. Specifically, the gold pad 21 is a portion containing a label-attached antibody, and the label is a fluorescent compound such as florescein, phycobiliprotein, and rhodamine, a chemiluminescent compound, a metal sol, a dye sol, and a color indicator. It may be one or more types selected from the group consisting of, but is not limited thereto. The label-attached antibody may preferably be a conjugate of gold and antibody.

In particular, the present invention includes a labeled anti-standard antibody (212) as a label-attached antibody on the gold pad (21), and thus the standard substance and the labeled anti-standard substance present in the diagnostic sample. A complex 212a of an antibody and a standard substance can be formed. This label-attached anti-standard antibody and standard substance conjugate (212a) can be visualized in combination with the anti-standard antibody (511) in the sample validation line (51) of the present invention. The ‘anti-standard material’ is as described above. In particular, in the present invention, the labeled anti-standard antibody is preferably a labeled anti-human IgM antibody.

In addition, the present invention also includes a label-attached disease detection antibody 211 as a label-attached antibody on the gold pad 21, and accordingly, disease marker substances and label-attached disease detection antibodies and antigens present in the diagnostic sample. A combination 211a can be formed. This label-attached complex of disease detection antibody and antigen (211a) can be visualized in combination with the disease detection antibody (411) in the test line (40) of the present invention.

The test line 40 has one or more stationary phases selected from disease marker substances and antibodies that can be obtained through an immune reaction, and conventional techniques can be applied without limitation. The disease marker material is not particularly limited as long as it is a marker material that can confirm the presence or absence of the disease to be diagnosed. For example, it may be an antigen, such as a protein such as a disease-causing bacterium or virus, or a part thereof, or a variant thereof. , It may be a substance generated in the body through the above disease. As an example, the disease marker may be a COVID-19 virus antigen or antibody, and an antigen of the COVID-19 virus is more suitable for the present invention.

The sample validity confirmation line 51 confirms the effectiveness of sample collection, thereby improving the reliability of the immunodiagnostic kit, and the contents of the <specimen validity confirmation line> described above are applied without limitation.

The control line 50 is a line that determines whether the immunodiagnostic kit has been properly developed using the diagnostic sample, and conventional techniques can be applied without limitation.

The immunodiagnostic kit includes a lower case (not shown) supporting one side of the sample pad 20, analysis strip 30, and absorption pad 60; And an upper case (not shown) coupled to the lower case, covering the other side of the absorption pad 60, and including a sample inlet corresponding to the sample pad 10 and a result display window corresponding to the absorption pad 60. Poetry) may be additionally included.

The lower case is formed to support one side, for example, the lower side, of the embedded analysis strip. The upper case is formed to cover the other side, for example, the upper side, of the analysis strip that is coupled to and embedded in the lower case.

The upper case may include a sample input port formed corresponding to the sample pad, and a result display window formed corresponding to the test line 40 and the sample validity confirmation line 51.

In addition, the scope of the present invention is a method of confirming the effectiveness of specimen collection using the specimen validity confirmation line and/or immunodiagnostic kit described above.

Specifically, the method for confirming the effectiveness of sample collection of the present invention includes adding a diagnostic sample to the above-described immunodiagnostic kit; A step of forming a conjugate by combining the standard substance in the diagnostic sample with the labeled anti-standard substance antibody on the gold pad; and detecting the conjugate using an anti-standard antibody of the sample validity confirmation line.

All contents described in the <Sample validity confirmation line> and <Immunodiagnostic kit> items above apply without limitation to the method for confirming the effectiveness of sample collection of the present invention.

Hereinafter, experimental examples including specific examples and comparative examples are presented to aid understanding of the present invention, but these are only illustrative of the present invention and do not limit the scope of the appended claims, and do not limit the scope and technical idea of the present invention. It is obvious to those skilled in the art that various changes and modifications to the embodiments are possible within the scope, and it is natural that such changes and modifications fall within the scope of the appended patent claims.

Preparation Example 1: Preparation of an immunodiagnostic kit including a sample validity confirmation line according to the present invention

The analysis strip 30 of the present invention was prepared as follows. Anti-human IgM and human IgG (Human IgG1 Anti SARS-CoV-2 Spike (S1) Antibody) were coated on the nitrocellulose membrane. Specifically, a nitrocellulose membrane mixed with 30 parts by weight of polylactic acid with an average molecular weight of 30,000 to 50,000, 65 parts by weight of 80 w/w% ethanol, and 5 parts by weight of 1% sodium caseinate was used to confirm the validity of each sample (51). and applied to the line position of the test line 40, dried at 40°C for about 10 minutes, and then 1㎕ of each 1㎍/㎕ antibody aqueous solution was applied to the same line position, and then the antibody aqueous solution was absorbed into the membrane and formed at the band position. Antibodies were fixed. Then, the nitrocellulose membrane was dried.

Additionally, the gold pad 21 was manufactured as follows. First, gold condensate was prepared as colloidal particles as follows. When the 0.1% HAuCl4 solution starts to boil while stirring and heating, 0.5% sodium citrate solution is added to reduce the solution to make gold particles, and the NP and anti-human IgM of SARS-CoV-2 known here are added to the gold particle solution. and condensed. Specifically, a polyester membrane was prepared and cut to a width similar to the analysis strip 30, and 0.4 M of Tris (pH 6.5), 0.2% of Tween-20, 1% of sodium caseinate, and 0.1% of sodium azide were added. azide), and 0.05% Proclin 300. The prepared gold condensate was prepared by dialyzing a solution with the same composition as the above solution. Then, the dialyzed gold condensate was treated with the polyester and dried to complete the gold pad 21.

Then, a membrane made of glass fiber was prepared with an absorbent pad (60), Cytocep 1662, and a sample pad (20), and then each pad was placed to complete the kit.

Experimental Example 1: Confirmation of sample collection effectiveness of the immunodiagnostic kit of the present invention

Using the immunodiagnostic kit according to Example 1, a coronavirus diagnosis was performed by collecting samples from 9 people randomly selected by gender, age, etc. by sweeping the nasal cavity using a cotton swab.

Figure 6 shows that, using the immunodiagnostic kit of the present invention, samples were collected from 9 people according to the standard sample collection method, and when samples were collected without following the standard sample collection method, each was tested and the sample collection was performed. This diagram shows the results of confirming effectiveness. 'Standard' means that the sample was collected by rotating the swab 10 times on both sides of the nose according to the instructions, and 'one round trip' means that the sample was simply put in and removed from the nose without being collected according to the standard instructions, as shown in the table above. 'Neg' refers to the extract from which no sample was collected, and shows the results when only the sample extract was developed without the sample collection process.

Referring to Figure 6, it can be seen that the sensitivity is high when sample collection is performed according to standard instructions.

10 Diagnostic samples
20 sample pad
21 Gold Pad
211 Label-attached disease detection antibodies
211a Label-attached disease detection antibody and antigen conjugate
212 Labeled Anti-Standard Antibodies
212a Labeled Anti-Standard Conjugate of Antibody and Standard
211b Label-attached disease detection antibody and antigen and conjugate of the antibody
212b Labeled anti-standard antibodies and conjugates of standards and antibodies
222 Labeled control line identification antibody
30 analysis strips
40 inspection line
411 Disease detection antibodies
51 Sample validity confirmation line
511 anti-standard antibody
522 control line confirmed antibody conjugate
60 absorbent pads

Claims (10)

A sample validation line containing an anti-standard antibody that specifically binds to one or more standards selected from IgG, IgA, IgM, albumin, and transferrin.
The method of claim 1, wherein the standard substance is IgM.
An immunodiagnostic kit containing a sample pad, gold pad, analysis strip, and absorption pad.
The analysis strip includes a test line and a sample validity confirmation line,
An immunodiagnostic kit, wherein the sample validity confirmation line is a sample validity confirmation line according to claim 1.
In claim 3,
An immunodiagnostic kit, wherein the sample validity confirmation line is comprised of a control line and a sample validity confirmation line.
In claim 3,
An immunodiagnostic kit, wherein the analysis strip further includes a separate control line.
In claim 3,
The gold pad contains a labeled anti-standard antibody,
Immunity diagnostic kit.
In claim 6,
The labeled anti-standard antibody is a labeled anti-human IgM antibody,
Immunity diagnostic kit.
In claim 6,
To confirm the effectiveness of sample collection by detecting standard substances in diagnostic samples,
Immunity diagnostic kit.
In claim 8,
The standard substance in the diagnostic sample combines with the labeled anti-standard substance antibody on the gold pad to form a conjugate.
The anti-standard antibody of the sample validity confirmation line is for detecting the conjugate.
Immunity diagnostic kit.
A method of confirming the effectiveness of sample collection using the immunodiagnostic kit according to any one of claims 3 to 9,
Adding a diagnostic sample to an immunodiagnostic kit;
A step of forming a conjugate by combining the standard substance in the diagnostic sample with the labeled anti-standard substance antibody on the gold pad; and
Detecting the conjugate using an anti-standard antibody of the sample validity confirmation line,
How to determine the validity of specimen collection.